Multiple Function Device Products: Policy and Considerations - Guidance for Industry and Food and Drug Administration Staff

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Multiple Function Device Products:

Policy and Considerations

Guidance for Industry and

Food and Drug Administration Staff

Document issued on July 29, 2020.

The draft of this document was issued on April 27, 2018.

For questions about this document regarding CDRH-regulated devices, contact the Division of

Digital Health at [email protected]. For questions about this document regarding

CBER-regulated devices, contact the Office of Communication, Outreach and Development

(OCOD), by calling 1-800-835-4709 or 240-402-8010, or by email at [email protected]. For

questions about this document regarding CDER-regulated products, contact the Center for Drug

Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51,

Rm. 6158, Silver Spring, MD 20993-0002, 301-796-8936. For questions about this document

regarding combination products, contact the Office of Combination Products at

[email protected].

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

Office of Combination Products in the Office of the Commissioner

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Preface

Public Comment

You may submit electronic comments and suggestions at any time for Agency consideration to

https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food

and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.

Identify all comments with the docket number FDA-2018-D-1339. Comments may not be acted

upon by the Agency until the document is next revised or updated.

Additional Copies

CDRH

Additional copies are available from the Internet. You may also send an e-mail request to CDRH-

[email protected] to receive a copy of the guidance. Please use the document number 17038

and complete title of the guidance in the request.

CBER

Additional copies are available from the Center for Biologics Evaluation and Research (CBER),

Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,

Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-

8010, by email, [email protected], or from the Internet at https://www.fda.gov/vaccines-blood-

biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

CDER

Additional copies are available from the Center for Drug Evaluation and Research, Office of

Communications, Division of Drug Information, 10001 New Hampshire Ave., Hillandale Bldg.,

4th Floor, Silver Spring, MD 20993-0002, or by calling 855-543-3784 or 301-796-3400, or by

email, [email protected], or from the Internet at https://www.fda.gov/drugs/guidance-

compliance-regulatory-information/guidances-drugs.

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Table of Contents

I. Introduction ........................................................................................................................................................... 1

II. Background ........................................................................................................................................................... 2

III. Scope..................................................................................................................................................................... 4

IV. Policy: Premarket Review of Multiple Function Device Products ....................................................................... 5

V. Considerations for Multiple Function Device Products ........................................................................................ 6

A. Separation in Design and Implementation of the Device Function .................................................................. 6

B. Impact of “Other Functions” ............................................................................................................................ 7

VI. Assessing the Impact of “Other Functions” on the Device Function-Under-Review ........................................... 8

A. Is There an Impact on the Safety or Effectiveness of the Device Function-Under-Review as a Result of the

“Other Function?” ...................................................................................................................................................... 9

B. Could the Impact Result in Increased Risk or Have an Adverse Effect on Performance, i.e., a Negative

Impact? .................................................................................................................................................................... 10

1. Impacts to Safety ......................................................................................................................... 11

2. Impacts to Effectiveness ............................................................................................................. 11

VII. Content of a Premarket Submission for Device Function-Under-Review .......................................................... 12

A. Indications for Use ......................................................................................................................................... 13

B. Device Description – Description of Functions .............................................................................................. 13

C. Labeling .......................................................................................................................................................... 14

D. Architecture and Design ................................................................................................................................. 14

E. Device Hazard Analysis ................................................................................................................................. 14

F. Requirements and Specifications .................................................................................................................... 15

G. Performance Testing ....................................................................................................................................... 15

H. Submission Summary ..................................................................................................................................... 15

VIII. Modifications to the “Other Function” of a Multiple Function Device Product ................................................. 16

IX. Application of Other Device and Postmarket Requirements .............................................................................. 17

Appendix 1: Examples of Multiple Function Device Products .................................................................................. 18

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Multiple Function Device Products:

Policy and Considerations

Guidance for Industry and

Food and Drug Administration Staff

This guidance represents the current thinking of the Food and Drug Administration (FDA or

Agency) on this topic. It does not establish any rights for any person and is not binding on

FDA or the public. You can use an alternative approach if it satisfies the requirements of the

applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff

or Office responsible for this guidance as listed on the title page.

I. Introduction

Medical products may contain several functions, some of which are subject to FDA’s regulatory

oversight as medical devices, while others are not. Section 3060(a) of the 21st Century Cures

Act (Cures Act) amended the Federal Food Drug, and Cosmetic Act (FD&C Act) to add section

520(o), which excludes certain software functions from the definition of device in section 201(h)

of the FD&C Act. The Cures Act also states that in the case of a product with multiple functions

that contains both a software non-device function and a device function, FDA may assess the

impact that the software non-device function has on the device function when assessing the

safety and effectiveness of the device function (section 520(o)(2) of the FD&C Act). FDA

believes that a similar approach should be used for the assessment of all multiple function device

products.

Products with at least one device function and at least one “other function” (see Section III) are

referred to in this guidance as “multiple function device products.” For purposes of this

guidance, for any given product, the term “function” is a distinct purpose of the product, which

could be the intended use or a subset of the intended use of the product.

This guidance explains

FDA’s regulatory approach and policy for all multiple function device products. Specifically,

this guidance clarifies when and how FDA intends to assess the impact of “other functions” that

are not the subject of a premarket review on the safety and effectiveness of a device function that

is subject to FDA review. The purpose of this guidance is to identify the principles, premarket

A device per section 201(h) of the FD&C Act may be comprised of one or more device functions. The term

“function” is not synonymous with the term “device.” “Distinct purpose of the product,” as used in this guidance to

explain the meaning of “function,” is not synonymous with “primary intended purposes” in section 201(h) of the

FD&C Act.

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review practices, and policies for FDA’s regulatory assessment of such products, and to provide

examples of the application of these policies.

For the current edition(s) of the FDA-recognized consensus standard(s) referenced in this

document, see the FDA Recognized Consensus Standards Database.

For more information

regarding use of consensus standards in regulatory submissions, please refer to the FDA

guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

for Medical Devices”

and “Standards Development and the Use of Standards in Regulatory

Submissions Reviewed in the Center for Biologics Evaluation and Research.”

FDA’s guidance documents, including this guidance, do not establish legally enforceable

responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should

be viewed only as recommendations, unless specific regulatory or statutory requirements are

cited. The use of the word should in Agency guidance means that something is suggested or

recommended, but not required.

II. Background

Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a device as:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other

similar or related article, including any component, part, or accessory, which is:

· recognized in the official National Formulary, or the United States Pharmacopoeia, or

any supplement to them,

· intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,

treatment, or prevention of disease, in man or other animals, or

· intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on

the body of man or other animals and which is not dependent upon being metabolized for the

achievement of its primary intended purposes. The term "device" does not include software

functions excluded pursuant to section 520(o).

Functions that fall within this definition are devices and, therefore, subject to FDA’s oversight.

FDA’s regulation of devices is tailored based on risk. For example:

Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-

voluntary-consensus-standards-premarket-submissions-medical-devices.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-

and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation.

A software function described in section 520(o)(1)(C)-(E) of the FD&C Act is not excluded from the device

definition under 201(h) if the software meets the criteria under section 513(a)(1)(C) of the FD&C Act or if the

software is used in the manufacture and transfusion of blood and blood components to assist in the prevention of

disease in humans (section 520(o)(4)(B) and (C) of the FD&C Act).

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· Some devices are subject to premarket review, either through a premarket notification

under section 510(k) of the FD&C Act, a premarket approval (PMA) application under

section 515 of the FD&C Act, a De Novo classification request under section 513(f)(2) of

the FD&C Act, an investigational device exemption (IDE) application under 21 CFR 812,

or a humanitarian device exemption (HDE) under section 520(m) of the FD&C Act.

Certain devices are subject to premarket review through a biological license application

(BLA) under section 351 of the Public Health Service Act.

· Other, lower-risk devices are exempt from premarket review, but are subject to general

controls, including registration and listing,

good manufacturing practices,

and adverse

event reporting.

· FDA has issued guidance that it does not intend to focus its regulatory oversight on some

devices that pose a low risk to patients. FDA has done this for many low-risk software

functions. See, for example, FDA’s guidance “Policy for Device Software Functions and

Mobile Medical Applications”

and “General Wellness: Policy for Low Risk Devices.”

On December 13, 2016, the Cures Act was signed into law. Section 3060(a) of this legislation,

titled “Clarifying Medical Software Regulation,” amended the FD&C Act to add section 520(o),

which describes software functions that are excluded from the definition of the term device in

section 201(h). In addition, section 520(o)(2), reproduced below, describes the regulation and

assessment of a software product with multiple functions, including at least one device function

and at least one software function that is not a device.

Section 520(o)(2) of the FD&C Act (21 U.S.C. 360j(o)(2))

In the case of a product with multiple functions that contains—

(A) at least one software function that meets the criteria under

paragraph (1) or that otherwise does not meet the definition of device

under section 201(h); and

(B) at least one function that does not meet the criteria under

paragraph (1) and that otherwise meets the definition of a device under

section 201(h),

the Secretary shall not regulate the software function of such product

described in subparagraph (A) as a device. Notwithstanding the

preceding sentence, when assessing the safety and effectiveness of the

device function or functions of such product described in subparagraph

(B), the Secretary may assess the impact that the software function or

functions described in subparagraph (A) have on such device function

or functions.

Section 510 of the FD&C Act.

Section 520(f) of the FD&C Act.

Section 519 of the FD&C Act.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-

functions-and-mobile-medical-applications.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-

policy-low-risk-devices.

Contains Nonbinding Recommendations

III. Scope

As mentioned above, in this guidance for any given product, the term “function” is a distinct

purpose of the product, which could be the intended use or a subset of the intended use of the

product. For example, a product with an intended use to analyze data has one function: analysis.

A product with an intended use to store, transfer, and analyze data has three functions: (1)

storage, (2) transfer, and (3) analysis. As this example illustrates, a product may contain

multiple functions.

The following terms are used for the purposes of this guidance:

· Device function: function that meets the definition of a device under section 201(h) of the

FD&C Act.

· “Other function:” function that:

· does not meet the definition of device;

· meets the definition of device, but is not subject to premarket review (e.g.,

510(k)-exempt

); or

· meets the definition of device, but for which FDA has expressed its intention not

to enforce compliance with applicable regulatory controls.

· Device function-under-review: function for which FDA is conducting premarket review.

A multiple function device product contains at least one device function and at least one “other

function.” In the premarket review context (see Sections IV-VIII), a multiple function device

product is a product with at least one device function-under-review and one “other function.”

For example, during premarket review of a multiple function device product, a device function

that requires a PMA would be evaluated according to the principles in this guidance. In the

postmarket context (see Section IX), a multiple function device product is a product with at least

one device function that is the focus of FDA’s oversight and one “other function.” For example,

during an inspection of a facility manufacturing a multiple function device product, the

principles of this guidance would apply to a 510(k)-exempt device function. In accordance with

existing policies, FDA intends not to review a device function subject to an enforcement

discretion policy merely because it is part of a multiple function device product.

Although section 520(o)(2) of the FD&C Act applies to the regulation of products containing at

least one device function and at least one non-device software function, FDA believes the same

principles should apply to the assessment of all multiple function device products, whether those

functions are software-based, hardware-based, or both. This document does not provide

guidance on which functions do and do not meet the definition of a device. It also does not

provide guidance on which functions meet the device definition but are those for which FDA has

expressed its intention not to enforce compliance with applicable requirements of the FD&C Act.

Note that a device may not be 510(k)-exempt if it exceeds the limitations outlined in 21 CFR Part 862.9 through

892.9. A similar analysis would apply for drug- or biologic-led combination products.

“Nothing in this subsection shall be construed as limiting the authority of the [FDA] to— (A) exercise

enforcement discretion as to any device subject to regulation under this Act . . .” (section 520(o)(4) of the FD&C

Act).

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Sections IV-VI and VIII-IX of this document discuss the policy in this guidance for multiple

function device products, as well as modifications to “other functions” and postmarket

requirements. Generally, these policies (in Sections IV-VI and VIII-IX) apply to device

functions-under-review within a multiple function device product, including multiple function

device products included in a combination product.

Section VII addresses the premarket

submission content for device functions-under-review of a multiple function device product; this

approach also applies to multiple function device products that are part of a device-led

combination product. Similar principles may apply for drug- or biologic-led combination

products that include a multiple function device product. This guidance does not address the

premarket submission requirements, nor submission requirements for modifications, of a drug or

biologic constituent part of a combination product. This guidance does not change FDA’s review

of a drug or biologic constituent part of a combination product.

The principles outlined in this guidance reflect a safety-based approach to risk management

aligned with ANSI/AAMI/ISO 14971: Medical devices – Application of risk management to

medical devices.

IV. Policy: Premarket Review of Multiple Function Device

Products

Consistent with the FD&C Act, as amended by the Cures Act, certain software functions in a

multiple function device product are not a device because they do not meet the statutory device

definition in section 201(h) of the FD&C Act.

Such “other functions” are not the subject of

FDA’s review simply because they are part of a multiple function device product. However,

FDA may assess the impact of “other functions” when assessing the safety and effectiveness of

the device functions-under-review of a multiple function device product.

For example, FDA does not regulate a general-purpose computing platform, but may assess its

impact on the safety and effectiveness of a device function-under-review, such as a mobile

medical application.

This approach is similar to how FDA considers a product that includes an

intragastric balloon subject to premarket approval and an endoscope accessory that is 510(k)-

exempt (e.g., an endoscope guidewire); in this case, FDA may assess the impact of the

endoscope accessory on the safety and effectiveness of the intragastric balloon.

For some device functions, FDA has expressed its intention not to enforce compliance with

applicable requirements. In accordance with existing policies, FDA intends not to review a

device function subject to an enforcement discretion policy merely because it is part of a

21 CFR 3.2(e).

520(o)(2) of the FD&C Act.

Please see the “Policy for Device Software Functions and Mobile Medical Applications” guidance document for

the definition of mobile medical application, available at https://www.fda.gov/regulatory-information/search-fda-

guidance-documents/policy-device-software-functions-and-mobile-medical-applications.

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multiple function device product.

Instead, FDA intends to review the device function(s) for

which clearance or approval is being sought (e.g., the device function-under-review). For

example, if a manufacturer seeks clearance or approval for a device function (e.g., analysis), and

not the device function for which FDA has expressed its intention not to enforce compliance

(e.g., trend), then FDA intends to only review the analysis function and assess the trend function

only insofar as it could negatively impact the analysis function. In that instance, because FDA is

reviewing the analysis function only, FDA’s decision to clear or approve applies only to the

analysis function.

As described in Section VI.A, in their risk assessment process, manufacturers should determine

if an “other function” impacts the safety or effectiveness of the device function-under-review.

Such impacts can be negative, e.g., “other functions” that may adversely affect the performance

of the device function-under-review by slowing computation time, or positive, e.g., “other

functions” that enhance safety and effectiveness of the device function-under-review because

they improve processing speed. As described in Section VII, for multiple function device

products, manufacturers should provide in their premarket submission information that is related

to the impacts of “other functions” only if they could negatively impact the device function-

under-review or if they positively impact the device function-under-review and this fact will be

represented in the device function-under-review’s labeling (“labeled positive impact”). For those

premarket submissions during which FDA reviews draft labeling, a labeled positive impact

should be included in the indications on the CDRH Premarket Review Submission Cover

Sheet.

Although FDA does not recommend submitting information about all positive impacts

from “other functions” in a premarket submission, all impact assessments (negative, positive,

and no impact) must be performed and documented as part of design validation under 21 CFR

820.30(g) for multiple function device products (see also Section VII) and are subject to FDA

review during an inspection.

V. Considerations for Multiple Function Device Products

FDA guidances with premarket submission recommendations for medical devices apply to

products with at least one device function-under-review. The following sections describe

additional considerations for multiple function device products. However, there is no one-size-

fits-all approach for the wide variety of multiple function device products, and manufacturers

should consider their products’ specific functions and conditions of use.

A. Separation in Design and Implementation of the Device

Function

“Nothing in this subsection shall be construed as limiting the authority of the [FDA] to— (A) exercise

enforcement discretion as to any device subject to regulation under this Act . . .” (section 520(o)(4) of the FD&C

Act).

Please see the CDRH Premarket Review Submission Cover Sheet, available at https://www.fda.gov/medical-

devices/premarket-notification-510k/content-510k.

During an inspection, upon FDA’s request, a manufacturer must allow FDA to access, copy, and verify certain

records, including the results of the design validation. See sections 704(a) & (e) of the FD&C Act; see also 21 CFR

820.180.

Contains Nonbinding Recommendations

The device function-under-review should, to the extent possible, be separated from “other

functions” in its design and implementation (e.g., logical separation, architectural separation,

code, and data partitioning). The use of partitions in software systems can be an effective or

sometimes necessary strategy to limit hazardous situations and to reduce risk in order to prevent

the “other function” from negatively impacting the device function-under-review.

Documenting the results of a thorough risk analysis of the impacts of “other functions” and

mitigation strategies employed is a critical component of a risk management process. The higher

the degree of separation, the easier it is to independently review the safety and effectiveness of

the device function-under-review. Separation will also increase the likelihood that the device

function-under-review is not dependent on the “other function(s)” in the product.

Architecture decisions early in the design cycle can facilitate optimal separation and support

segregation necessary for risk control. When separation is not achievable, the interconnection

and interdependencies between the device function-under-review and “other functions” should

be explained and included in the hazard analysis, and appropriate controls should be created to

reduce the adverse impact of the connectivity on the safety and effectiveness of the device

function-under-review.

When considering cybersecurity risks, some level of separation of the device function-under-

review from the “other function(s)” in design and implementation may be necessary to mitigate

cybersecurity risks to the device function-under-review. For example, modular and/or separation

architectures can help reduce the possibility that a cybersecurity threat to/from an “other

function” could impact the device function-under-review.

See Sections VI and VII for discussion regarding how to assess the impact of “other functions”

on the device function-under-review and what content resulting from this assessment should be

included in a premarket submission for the device function-under-review.

B. Impact of “Other Functions”

The manufacturer of a multiple function device product should consider the following regarding

all “other functions” of the product:

• the role of the “other function” in the device function-under-review’s performance;

• any limitations of the device function-under-review when using the “other function;”

• developing appropriate hardware and software resource specification(s) for the product

with multiple functions to ensure minimal impact of the “other function” on the

performance of the device function-under-review;

• how to ensure appropriate actions are taken by the end user when using the device

function-under-review with the “other function;” and

• identification, evaluation, and mitigation of any additional risks, including cybersecurity

risks, in the device function-under-review when used in combination with the “other

function.”

Contains Nonbinding Recommendations

VI. Assessing the Impact of “Other Functions” on the

Device FunctionUnderReview

In the premarket review of a device function-under-review, FDA may assess the impact of “other

functions” on the device function-under-review. The premarket assessment of a product with

multiple functions is summarized in a two-step process:

(A) Is there an impact on the safety or effectiveness of the device function-under-review

as a result of the “other function?;” and, if there is an impact,

(B) Could the impact result in increased risk or have an adverse effect on performance of

the device function-under-review, i.e., negative impact?

The flowchart below is intended as a guide to be used with the textual descriptions in this

guidance.

Each decision point in the flowchart and its relevant considerations are described in the Sections

below. Section VII describes what should be included in the documentation for a premarket

submission for a multiple function device product if the device function-under-review is

impacted by the “other function,” and if the impact could result in increased risk or an adverse

effect on performance.

Contains Nonbinding Recommendations

A. Is There an Impact on the Safety or Effectiveness of the

Device FunctionUnderReview as a Result of the “Other

Function?”

Manufacturers should determine if an “other function” impacts the safety or effectiveness of the

device function-under-review. If so, FDA recommends that manufacturers evaluate that impact

and include the relevant parts of the “other function” in their hazard analysis.

When assessing the impact of “other functions” on the device function-under-review, it is

important to consider the various relationships between the functions that may exist in a multiple

function device product. The existence of a relationship does not necessarily mean that there

may be an impact on the safety or effectiveness of the device function-under-review. For

example, a software device function, including a mobile medical application, has a relationship

with the computing platform on which it is executed. The computing platform may or may not

Contains Nonbinding Recommendations

have an impact on the safety or effectiveness of the software device function. See the examples

in Appendix 1: Examples of Multiple Function Device Products.

When assessing if an “other function” impacts the device function-under-review within the same

product, considerations should include whether there are shared computational resources, data

dependencies, or any other type of relationship between the functions. The following are

examples of questions that may help to determine if an “other function” may impact the safety or

effectiveness of the device function-under-review. Note that this is not intended to be a

comprehensive list of considerations, and manufacturers should conduct their own risk

assessments.

• Does the “other function” provide input data that is used for a critical calculation

within the device function-under-review?

• Does the device function-under-review rely on results from the “other function?”

• Do the “other function” and the device function-under-review share code that is

necessary for proper execution of the device function-under-review?

• Does the “other function” write to memory or other storage that stores code or data of

the device function-under-review? (E.g., does the “other function” directly modify the

configuration of the device function-under-review, bypassing the designed input and

output methods?)

• Do the “other function” and the device function-under-review share the same output

screen or graphical user interface?

• Does the “other function” affect the processing time necessary for the performance of

the device function-under-review when the functions share a processor?

• Does the “other function” affect the memory requirements for the performance of the

device function-under-review when the functions share memory on the computer

platform?

• Do the “other function” and the device function-under-review share programming

pointers?

• Does the device function-under-review need privileges to prevent delays or

interruptions that may result from the “other function?”

B. Could the Impact Result in Increased Risk or Have an

Adverse Effect on Performance, i.e., a Negative Impact?

If the “other function” impacts the device function-under-review, the extent of the impact should

be evaluated and included in the hazard analysis. The manufacturer should determine whether

the impacts could be positive or negative. For positive impacts, the manufacturer should identify

the beneficial impact that the “other function” has on the device function-under-review when

operating as intended and confirm that there is no adverse impact on the device function-under-

review if the “other function” were to fail to operate as intended. For negative impacts, the

manufacturer should identify whether there could be increased risk and/or an adverse effect on

performance due to the combination of the “other function” with the device function-under-

review.

Contains Nonbinding Recommendations

1. Impacts to Safety

The impacts to safety are often impacts associated with risk. A risk-based assessment should be

used to identify and analyze all risks of a device function-under-review, including those that may

result from the inclusion of “other functions” in the product. If the impact results in no increased

risk, then no additional risk mitigation is necessary. If there could be increased risk, then the risk

should be appropriately documented and mitigated, and the appropriate verification and/or

validation should be performed to ensure the effectiveness of the mitigation. The following

examples can be used as a guide to understand increased risk.

· The “other function” introduces a new hazardous situation or a new cause of an existing

hazardous situation that is not otherwise present in the device function-under-review.

o A “hazardous situation” exists when there is exposure to a hazard (i.e., a potential

source of harm) that can lead to physical injury or damage to the health of people.

· The “other function” increases the severity of harm associated with a hazardous situation

identified for a device function-under-review.

· The “other function” is a risk control measure for a device function-under-review.

· The use of or implementation of the “other function” impacts a risk control measure for a

device function-under-review.

When assessing the cybersecurity risks of “other functions” on the device function-under-review,

it should be assumed that the “other function(s)” may be employed (maliciously or

unintentionally) to cause an adverse impact on the device function-under-review (e.g., as a result

of a cyberattack). For example, the unavailability of the device function-under-review could

present risks that should be considered and appropriately mitigated, because a cybersecurity

threat to the “other function(s)” may lead to the device function-under-review becoming

unavailable to the intended user. Software transparency methods aid in the identification of

software dependencies between a device function-under-review and “other function(s),” as well

as identify vulnerable software components in “other functions” that can be used to impact

device functions.

2. Impacts to Effectiveness

The impacts to effectiveness are typically impacts to the performance of the device, for example,

impacts to the responsiveness, usability, or efficiency of the device. If there could be adverse

impacts to the device function-under-review as a result of the “other function(s),” then

appropriate verification and validation should be performed with the product to characterize the

performance of the device function-under-review and evaluate if there may be an adverse effect

on the performance. The following examples can be used as a guide to determine whether there

could be an adverse impact on performance.

One example of such a software transparency method is a Software Bill Of Materials that lists software

components – including commercial, open source, off-the-shelf, and custom software components – and can aid in

the management of risk in both medical device manufacturer-developed software components and purchased, third-

party components, which may comprise “other functions.” Please see, for example, “Healthcare Sector

Coordinating Council (HSCC) Joint Strategy Plan (JSP)” Appendix G, available at

https://healthsectorcouncil.org/the-joint-security-plan/.

Contains Nonbinding Recommendations

· The performance or clinical functionality of the device function-under-review depends on

the “other function” for the device function-under-review to perform as specified.

· The performance of the device function-under-review fails to meet the specified

performance level due to the “other function.”

Note that the relationship between a device function-under-review and the “other function(s)”

may be limited to sharing resources on a general-purpose computing platform. If the only

identified relationship between the device function-under-review and an “other function” is the

sharing of a common computing platform, the risk assessment for the device function-under-

review should include the hazards associated with running on a common general-purpose

computing platform. For examples of multiple function device products and explanations of the

assessment of how “other functions” impact the device function(s)-under-review, see Appendix

1: Examples of Multiple Function Device Products.

VII. Content of a Premarket Submission for Device

FunctionUnderReview

Under 21 CFR 820.30(g), a manufacturer must establish and maintain procedures for validating

its device design. Such design validation shall include software validation and risk analysis,

where appropriate. For a multiple function device product, FDA recommends that this validation

and risk analysis include an impact assessment and rationale for a manufacturer’s determination

of the impact of the “other function(s),” whether no impact, negative, or positive, on the device

function-under-review in accordance with the manufacturer’s quality system, where appropriate.

The impact assessment should include:

1) whether or not there is an impact on the safety or effectiveness of the device function-

under-review as a result of the “other function,” and if there is,

2) whether the impact could result in increased risk or either an adverse or positive effect on

performance.

FDA may request to see design validation documents, including, for example, the documentation

of the impact assessment of the “other function(s)” on the device function-under-review, during

an inspection.

If the “other function” does not impact the device function-under-review (i.e., there is no impact

on the safety and effectiveness of the device function-under-review), then the premarket

submission for the device function-under-review does not need to include the documentation

described in this section for the “other function,” consistent with FDA’s guidance “The Least

Burdensome Provisions: Concept and Principles.”

See 21 CFR 820.30(g) (requiring that the manufacturer establish and maintain procedures for validating the device

design and that design validation shall include software validation and risk analysis, where appropriate); see also

sections 704(a) & (e) of the FD&C Act; and 21 CFR 820.180 (FDA may request to review such records during an

inspection).

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-

provisions-concept-and-principles.

Contains Nonbinding Recommendations

If the “other function” could adversely impact the device function-under-review (i.e., the impact

of the “other function” may be increased risk or adverse effect on performance of the device

function-under-review), then the premarket submission for the device function-under-review

should include the appropriate documentation identified below for the “other function.”

If the device function-under-review could be positively impacted by the “other function” (i.e., the

impact of the “other function” has a beneficial impact on the device function-under-review when

operating as intended and does not have an adverse impact on the device function-under-review

if the “other function” fails to operate as intended; for example, the “other function” improves

the computational speed of the device function-under-review, and therefore positively impacts

the device function-under-review’s performance), and the sponsor would like the positive impact

to be considered in FDA’s assessment of the device function-under-review, then the premarket

submission for the device function-under-review should include the appropriate documentation

identified below for the “other function.” If the device function-under-review could be

positively impacted, but is not considered a labeled positive impact, then the submission does not

need to include the documentation described in this section for the “other function.”

A. Indications for Use

The indications for use should include only the indications for use

of the device function-

under-review. The indications for use should not include the indications for use of any “other

function,” unless the sponsor would like the positive impact to be considered in FDA’s

assessment of the device function-under-review.

B. Device Description – Description of Functions

The device description should include an explanation of the device’s functions.

For a multiple function device product, the device description should include a description of the

“other function(s)” that could adversely impact the device function-under-review and should

address how the device function-under-review is impacted by each of the “other functions.”

If the device function-under-review could be positively impacted by the “other function,” and the

labeling reflects the positive impact (labeled positive impact), the device description should

include the information outlined above in regard to the positive impact of the “other function” on

the device function-under-review.

Sponsors may also describe “other functions” that either do not have an impact or could have a

positive impact that is not suggested in the labeling of the device function-under-review, to

provide an explanation of how the device functions overall.

We have a long-standing policy of applying the definition of indications for use in the PMA regulation at 21 CFR

814.20(b)(3)(i) in the same way in the 510(k) context. See FDA guidance “The 510(k) Program: Evaluating

Substantial Equivalence in Premarket Notifications [510(k)],” available at https://www.fda.gov/regulatory-

information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-

notifications-510k.

Contains Nonbinding Recommendations

C. Labeling

FDA regulates device labeling in several ways. For example, section 502(f) of the FD&C Act

requires that labeling include adequate directions for use. Under section 502(a)(1) of the FD&C

Act, a medical device is deemed misbranded if its labeling is false or misleading in any

particular. Under section 201(n), labeling may be misleading if it fails to reveal facts material

with respect to consequences that may result from use of the article under the conditions of use

prescribed in the labeling or under such conditions of use as are customary or usual. See also 21

CFR 1.21.

For multiple function device products, the labeling should include a description of the “other

function(s)” adequate to ensure appropriate use of the device.

Device labeling must comply with applicable statutes and regulations.

When developing the

labeling for a multiple function device product, it may be necessary to include additional

information or limitations (e.g., contraindications, warnings, precautions, adverse reactions)

associated with the “other function(s),” or other instructions that are appropriate for your device,

depending on its specific design, features, and performance characteristics.

D. Architecture and Design

When the device function-under-review or “other function” includes software, the architecture

and design documents appropriate to the software level of concern should be included in the

premarket submission (“Guidance for the Content of Premarket Submissions for Software

Contained in Medical Devices”

) for the device function-under-review, and should include

adequate detail to understand how or if the “other function(s)” interact with or impact the device

function-under-review. For example, an architecture diagram may demonstrate the

independence of the device function-under-review from the “other function,” or design

documents may demonstrate the use of shared resources.

E. Device Hazard Analysis

The device hazard analysis included in the premarket submission for the device function-under-

review should include the results of a risk-based assessment of any potential adverse impact or

labeled positive impact of the “other function” to the safety or effectiveness of the device

function-under-review as discussed above. The results of the risk-based assessment should

document any risk mitigations employed to mitigate increased risk or adverse effect on

performance due to the combination of the “other function” with the device function-under-

review. For example, if the impact of the “other function” could result in decreased performance

See, e.g., 21 CFR 801.5 (requiring that labeling include adequate directions for use, including statements of all

conditions, purposes, or uses for which the device is intended (e.g., hazards, warnings, precautions,

contraindications); 21 CFR 801.109(c) (for prescription devices, requiring that labeling include any relevant

hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the

device can use the device safely and for the purpose for which it is intended).

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-

premarket-submissions-software-contained-medical-devices.

Contains Nonbinding Recommendations

of the device function-under-review, documentation should include the results of the risk

management process that identifies and describes the hazards that could affect the safety or could

cause decreased performance and any necessary risk mitigations employed. This risk-based

assessment could be performed using the process outlined in ANSI/AAMI/ISO 14971: Medical

devices – Application of risk management to medical devices, or the Device Hazard Analysis

from “Guidance for the Content of Premarket Submissions for Software Contained in Medical

Devices,”

for example.

F. Requirements and Specifications

Documentation of requirements and specifications included in the premarket submission for the

device function-under-review should include adequate detail to describe any expected

relationship, utility, reliance, or interoperability with any “other function.” Software

requirements documentation should describe the functional and non-functional requirements of

the software system, as identified in the “Guidance for the Content of Premarket Submissions for

Software Contained in Medical Devices,”

as appropriate.

G. Performance Testing

Performance testing for the device function-under-review should be conducted considering those

aspects of the “other function(s)” that have an impact (either if there could be an adverse impact

or labeled positive impact) on the performance in order to demonstrate that the impact to safety

or effectiveness is appropriately addressed. If you need to perform safety, performance, or other

testing, you should follow the relevant existing regulations, policies, guidances, and/or FDA-

recognized consensus standards for your device function-under-review.

H. Submission Summary

Where the device function-under-review could not be adversely impacted by an “other function,”

FDA does not intend to assess that “other function” (unless the sponsor would like FDA to

consider the positive impact of the “other function” in FDA’s assessment of the device function-

under-review). Therefore, an approved or cleared device may include functionality that FDA has

not assessed. FDA intends to make the extent of the product’s assessment clear, such as with a

statement in the 510(k) Summary, PMA Summary of Safety and Effectiveness Data (SSED), De

Novo Decision Summary, or HDE Summary of Safety and Probable Benefit (SSPB). For

example, if a product includes a device function-under-review and an “other function” that is not

subject to premarket review, the statement might read:

This medical device product has functions subject to FDA premarket review as well as

functions that are not subject to FDA premarket review. For this application, if the

product has functions that are not subject to FDA premarket review, FDA assessed those

functions only to the extent that they either could adversely impact the safety and

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-

premarket-submissions-software-contained-medical-devices.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-

premarket-submissions-software-contained-medical-devices.

Contains Nonbinding Recommendations

effectiveness of the functions subject to FDA premarket review or they are included as a

labeled positive impact that was considered in the assessment of the functions subject to

FDA premarket review.

VIII. Modifications to the “Other Function” of a Multiple

Function Device Product

If there is a modification to the “other function” of a multiple function device product, then, in

accordance with the policy in Section VI, the modification should be assessed to determine if the

change could significantly impact the safety or effectiveness of the device function that was the

subject of FDA review.

If you find such an impact on the device function that was the subject

of FDA review,

and it could adversely impact the device function or positively impact the device

function and that impact is included in the device function’s labeling (labeled positive impact),

then reference the “Deciding When to Submit a 510(k) for a Change to an Existing Device”

Guidance,

“Deciding When to Submit a 510(k) for a Software Change to an Existing Device”

Guidance,

or “Modifications to Devices Subject to Premarket Approval (PMA) - The PMA

Supplement Decision-Making Process” Guidance,

to help determine if a new premarket

submission is necessary for the modification to the “other function” as required by 21 CFR

807.81(a)(3). Unless the positive impact is included in the device function’s labeling (labeled

positive impact), if such a modification could positively impact the device function, then FDA

does not intend at this time to enforce the applicable premarket submission requirements.

The sponsor should document the impact assessment and justification for their determination of

impact of the modification of the “other function” on the device function-under-review in

accordance with the sponsor’s quality system. The impact assessment should include whether or

not there is an impact on the safety or effectiveness of the device function-under-review as a

result of the “other function,” and, if so, whether the impact could result in increased risk or

either an adverse or positive effect on performance.

If the modification to the “other function” of a multiple function device product is part of a

combination product that was submitted under a drug or biologic product application type, the

information related to the change should be submitted using the appropriate drug or biologic

submission, if required.

21 CFR 807.81(a)(3).

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-

510k-change-existing-device.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-

510k-software-change-existing-device.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-

subject-premarket-approval-pma-pma-supplement-decision-making-process.

For more information on requirements related to combination products, cross-cutting combination product

guidance documents are available at https://www.fda.gov/combination-products/guidance-regulatory-

information/combination-products-guidance-documents.

Contains Nonbinding Recommendations

IX. Application of Other Device and Postmarket

Requirements

General control requirements

apply to device functions subject to 510(k), PMA, De Novo, or

HDE requirements and to device functions that are 510(k)-exempt. For example, device

functions in multiple function device products must comply with design control requirements

under the Quality System regulation (21 CFR Part 820). As another example, in accordance with

21 CFR 803.50, FDA expects the manufacturer of a device function to investigate the cause of an

adverse event and to submit an adverse event report when the manufacturer becomes aware of

information that reasonably suggests that the device function may have caused or contributed to

a death or serious injury, among other circumstances.

If the manufacturer of a multiple function device product determines that an “other function”

affected the safety or effectiveness of the device function leading to a reportable death, serious

injury, or malfunction under 21 CFR Part 803, or is not certain about whether the device function

or an “other function” in a product caused or contributed to a reportable event, the manufacturer

would still be required to report it if the information reasonably suggests that the device may

have caused the death or serious injury.

FDA continues to intend not to enforce general control requirements for device functions for

which FDA has expressed its intention to not enforce applicable regulatory controls at this

time.

Combination products that include multiple function device products generally have additional

requirements, such as those requirements applicable to the drug or biologic constituent part. For

more information on current good manufacturing and postmarketing safety reporting

requirements and policies applicable to combination products, see 21 CFR Part 4, FDA “Current

Good Manufacturing Practice Requirements for Combination Products”

and the Office of

Combination Products’ (OCP’s) Postmarketing Safety Reporting for Combination Products

webpage.

Additional information on regulatory requirements and policies for combination

products can also be found on OCP’s webpage.

Sections 501, 502, 510, 516, 518, 519, 520(e), and 520(f) of the FD&C Act.

“Nothing in this subsection shall be construed as limiting the authority of the [FDA] to— (A) exercise

enforcement discretion as to any device subject to regulation under this Act . . .” (section 520(o)(4) of the FD&C

Act).

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-

manufacturing-practice-requirements-combination-products.

Available at https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-

reporting-combination-products.

Available at https://www.fda.gov/combination-products.

Contains Nonbinding Recommendations

Appendix 1: Examples of Multiple Function Device

Products

The following are hypothetical examples of multiple function device products, explaining the

impact assessment of the “other function” on the device function(s)-under-review. These

generalized examples are not intended to cover all possible details, risks, or considerations that

should be evaluated for multiple function device products. In addition, the examples are not

intended to describe all the details of the documentation necessary to demonstrate adequate risk

mitigation.

Example: Skin cancer detection software application

Product

A smart phone software application (app) that detects skin cancer from photos of

suspicious lesions of moles.

Functions

Device function-under-review:

· Software app that detects skin cancer

“Other function:”

· Smart phone computing platform

· Camera on the computing platform

Impact of the “other

function” on the device

function-under-review

The software app depends on the smart phone camera for the photos and depends on the

computing platform for the analysis.

Could there be increased

risk or adverse effect of

the “other function” on

the device function-under-

review

· The output of the camera may not be adequate for detecting skin cancer in photos of

suspicious lesions of moles, resulting in misdiagnosis.

· The smart phone’s computing platform performance may not be adequate to support

the software functions, including the algorithm intended to detect skin cancer in

photos of suspicious lesions of moles.

Documentation in the

premarket submission

demonstrating that the

increased risk or adverse

effect that could result

from the combination of

functions is mitigated

Documentation of

assessment in sponsor’s

quality system

· Document testing outcomes that demonstrate that there are adequate computing

resources (including screen size and resolution) and error handling to accommodate

the common computing platform including that the built-in camera provides

adequate images.

· Document description of specific feature(s) with adequate testing outcomes that

mitigate risk from software being used on a smart phone or inadequate camera.

· Documentation of specification for the use of the app with the camera and the

computing platform.

The sponsor should document the impact assessment and justification for their

determination regarding adverse impact of the “other functions” (camera output and

smart phone computing platform) in accordance with the sponsor’s quality system.

Assessment of “other

function” in the

premarket review

The smart phone platform and camera are not evaluated as part of the premarket review,

though the testing outcomes of the device function-under-review’s performance related

to using the smart phone and camera are evaluated. The software manufacturer is not

responsible for electromagnetic compatibility (EMC) or electrical safety testing of the

commercial smart phone.

Contains Nonbinding Recommendations

Example: Hand-held coagulation device

Product

A hand-held coagulation (prothrombin time) test device that interfaces with a hospital

information system (HIS) through a commercial off-the-shelf docking information

station hardware that meets appropriate U.S. Consumer Product Safety Commission

standards (electrical safety testing, safety certification, etc.) to transfer clinical in vitro

test data.

Functions

Device function-under-review:

· Hand held coagulation instrument

· Coagulation (prothrombin time) test

“Other function:”

· Docking station

· Interface to transmit the data to the HIS

Impact of the “other

function” on the device

function-under-review

The handheld instrument depends on the docking station for charging and data transfer.

Could there be increased

risk or adverse effect of

the “other function” on

the device function-under-

review

· Charging of the handheld instrument is necessary for device performance.

· The recharging of the battery introduces new hazardous situations for the instrument

itself.

· Instrument may be affected by erroneous or nontrusted data transfer from the HIS

system.

Documentation in the

premarket submission

demonstrating that the

increased risk or adverse

effect that could result

from the combination of

functions is mitigated

· Demonstrate that appropriate mitigations were implemented to address hazards

associated with battery charging.

· Document features authenticating data from trusted HIS system.

Documentation of

assessment in sponsor’s

quality system

The sponsor should document the impact assessment and justification for their

determination regarding adverse impact of the “other functions” (docking station and

interface software for data transfer) in accordance with the sponsor’s quality system.

Assessment of “other

function” in the

premarket review

The docking station and interface software are not evaluated as part of the premarket

review, though the hazard mitigation for the docking station battery and authentication

features for data transfer are evaluated as part of the device function-under-review’s

safety.

Contains Nonbinding Recommendations

Example: Traumatic brain injury determination

Product

A product that analyzes a user’s Electroencephalogram (EEG) signals recorded on a

computer platform and specialized hardware and uses data generated from an electronic

questionnaire to determine if the user has suffered from Traumatic Brain Injury (TBI) in an

acute period after an injury.

Functions

Device function-under-review:

· Collection and recording of EEG signals

· Analyzing EEG signals and diagnosing TBI

· Presentation of results

“Other function:”

· General-purpose computing platform

· Electronic administration of questionnaire

Impact of the “other

function” on the

device function-

under-review

The device algorithm depends on the results of the questionnaire.

Could there be

increased risk or

adverse effect of the

“other function” on

the device function-

under-review

· Inaccurate input of questionnaire results may impact the performance of the software.

· Computer performance may not be adequate to support the software functions including

the algorithm intended to determine if the patient has TBI.

· The output of the questionnaire may not be adequate for determining if the patient has

TBI.

Documentation in the

premarket submission

demonstrating that

the increased risk or

adverse effect that

could result from the

combination of

functions is mitigated

· Demonstrate that appropriate mitigations were implemented to limit or minimize

inaccurate input to the questionnaire.

· Demonstrate that the algorithm includes features to detect inaccurate input that may

impact the performance of the software.

· Testing outcomes demonstrating adequate computing resources (including screen size)

and error handling to accommodate the common computing platform.

· Description of specific feature(s) with adequate testing outcomes that mitigate risk from

software being used on a common computing platform.

Documentation of

assessment in

sponsor’s quality

system

The sponsor should document the impact assessment and justification for its determination

regarding adverse impact of the “other functions” (computing platform and questionnaire) in

accordance with the sponsor’s quality system.

Assessment of “other

function” in the

premarket review

The computing platform and the questionnaire are not evaluated as part of the premarket

review, though the impact to safety and performance related to using the computing platform

and questionnaire on the testing outcomes and risk mitigation for the device function-under-

review are evaluated. The manufacturer is not responsible for EMC or electrical safety

testing of the commercial computer.

Contains Nonbinding Recommendations

Example: Pain treatment app

Product

A Transcutaneous Electrical Nerve Stimulation (TENS) device controlled by an app on a

mobile platform worn by the user to treat pain.

Functions

Device function-under-review:

· Electrical Nerve Stimulation as a treatment for pain

· App used to control the level of stimulation

“Other function:”

· Mobile platform Bluetooth transceiver and connectivity

Impact of the “other

function” on the

device function-

under-review

The Bluetooth functionality of the mobile platform provides connectivity to the worn device

enabling remote control of the stimulation.

Could there be

increased risk or

adverse effect of the

“other function” on

the device function-

under-review

· The reliability and security of the Bluetooth connectivity could be compromised causing

the TENS device to operate in an uncontrolled manner.

Documentation in the

premarket submission

demonstrating that

the increased risk or

adverse effect that

could result from the

combination of

functions is mitigated

· Appropriate demonstration of applicable wireless coexistence and EMC safety standards

for the intended operating environment for the TENS worn part of the device to ensure

the reliability of the connection when used with the Bluetooth functionality.

· Demonstrate that appropriate cybersecurity controls are included in the design and

implementation of the device function-under-review to ensure the reliability and security

of the connection.

Documentation of

assessment in

sponsor’s quality

system

The sponsor should document the impact assessment and justification for their determination

regarding adverse impact of the “other function” (mobile platform Bluetooth transceiver and

connectivity) in accordance with the sponsor’s quality system.

Assessment of “other

function” in the

premarket review

The mobile platform Bluetooth transceiver is not evaluated as part of the premarket review,

though the evaluation outcomes of the device function-under-review’s safety and

performance related to EMC standards and cybersecurity mitigation are evaluated. The

manufacturer is not responsible for EMC or electrical safety testing of the Bluetooth product

itself.

Contains Nonbinding Recommendations

Example: Transmission of vital sign measures to an Electronic Health Record (EHR)

Product

A monitor that measures and displays vital physiological parameters and transmits them to an

Electronic Health Records (EHR) system through the hospital network using a built-in Wi-Fi

card.

Functions

Device function-under-review:

· Vital signs acquisition

“Other function:”

· Transmission software for sending data to the EHR system

· Wi-Fi card

Impact of the “other

function” on the

device function-

under-review

As an integral part of the device that allows for a network connection, the Wi-Fi card has

inherent risks associated with EMC and other wireless related risks (e.g., the vital

physiological parameters may be corrupted in transit to the EHR system), including

cybersecurity risks.

Could there be

increased risk or

adverse effect of the

“other function” on

the device function-

under-review

· The Wi-Fi card may affect both the performance and safety of the device or other devices

in the area.

· The network connection may affect the safety of the device by introducing cybersecurity

risks.

· The misfunction of the interface software may impact the safety of the device as the vital

physiological parameters may be corrupted in transit to the EHR system.

Documentation in the

premarket submission

demonstrating that

the increased risk or

adverse effect that

could result from the

combination of

functions is mitigated

Documentation of

assessment in

sponsor’s quality

system

· Demonstrate that appropriate cybersecurity controls were included in the design and

implementation of the product.

· Demonstrate that appropriate EMC and wireless testing was conducted and document

that the Wi-Fi card does not affect the performance of the monitor.

The sponsor should document the impact assessment and justification for their determination

regarding adverse impact of the “other functions” (transmission software and Wi-Fi card) in

accordance with the sponsor’s quality system.

Assessment of “other

function” in the

premarket review

The Wi-Fi card and transmission to the EHR are not evaluated as part of the premarket

review, though the cybersecurity controls and performance testing of the device function-

under-review are evaluated.

Contains Nonbinding Recommendations

Example: Energy-delivering device with optional app (MDDS)

Product

Energy-delivering aesthetic device with an optional mobile application (app) that transfers

treatment parameter data for cloud-based storage for later review by a physician.

Functions

Device function-under-review:

· Energy-delivering aesthetic device

“Other function:”

· Mobile app that integrates with device and transfers treatment parameter data (e.g.,

number of treatments, treatment parameters) to a cloud-based storage system – no

real-time transmission is allowed

· Smart phone computing platform

Impact of the “other

function” on the

device function-

under-review

The energy-delivering device function is not impacted by the mobile app or smart phone

computing platform because the transmission of data cannot occur during energy delivery.

· Note: In this scenario, cybersecurity and radio frequency present risks that are

inherent to the device function-under-review and are not introduced by the “other

functions.” Therefore, documentation on risk mitigation for those identified risks is

necessary for the premarket submission on the energy-delivering aesthetic device,

and not due to the mobile app or smart phone computing platform.

Could there be

increased risk or

adverse effect of the

“other function” on

the device function-

under-review

· Not applicable.

Documentation in the

premarket submission

demonstrating that

the increased risk or

adverse effect that

could result from the

combination of

functions is mitigated

· Not applicable.

Documentation of

assessment in

sponsor’s quality

system

The sponsor should document the impact assessment and justification for their determination

regarding no impact of the “other functions” (mobile app and smart phone computing

platform) in accordance with the sponsor’s quality system.

Assessment of “other

function” in the

premarket review

The mobile app and smartphone platform are not evaluated as part of the premarket review

and no documentation on the “other functions” is necessary for premarket submission of the

device function-under-review.

Contains Nonbinding Recommendations

Example: Pulsed ultrasound and biopsy needle guide kit

Product

An ultrasound pulsed echo imaging system with software-based biopsy needle tracking

functionality used to determine the depth or location of the tissue interfaces for use with

biopsy needle guide kit for delivery.

Functions

Device function-under-review:

· General purpose diagnostic ultrasound system

· Biopsy needle tracking functionality

“Other function:”

· 510(k)-exempt biopsy needle guide kit

Impact of the “other

function” on the

device function-

under-review

The biopsy needle guide kit is a convenience tray that combines a number of other ultrasound

accessories that have already received 510(k) clearance (e.g., needle guide brackets, sterile

ultrasound gel, sterile probe covers) or are class I 510(k)-exempt (e.g., sterile tray, drape

covers). The components of the kit are intended to aid with biopsy acquisition, specifically,

the biopsy needle tracking functionality that is guided via ultrasound imagery. The biopsy

needle tracking functions should be compatible with the biopsy needle guide kit. There are

no additional risks introduced by the biopsy needle guide kit, which has its own inherent

risks, such as possibility of compromising sterility, chance of infection, or potential cross-

contamination, which are not introduced due to the combination with the device function-

under-review.

Could there be

increased risk or

adverse effect of the

“other function” on

the device function-

under-review

· The biopsy needle tracking software may not be compatible with all ultrasound needle

biopsy kits. Incompatibility may lead to inaccurate or imprecise guiding of the needle to

the target area.

Documentation in the

premarket submission

demonstrating that

the increased risk or

adverse effect that

could result from the

combination of

functions is mitigated

· For biopsy needle tracking software intended to be compatible with various ultrasound

needle biopsy kits, performance testing should be provided showing that the accuracy

and precision meets the specifications and requirements for the subject device. For

example, data can show that the software, when used with the biopsy guide kit, guides

the needle to the target area within +/- 0.5 mm, which is substantially equivalent to the

predicate device.

Documentation of

assessment in

sponsor’s quality

system

The sponsor should document the impact assessment and justification for their determination

regarding potential adverse impact of the “other function” (biopsy needle guide kit) in

accordance with the sponsor’s quality system. The sponsor should document that any further

processing of the kit and its components does not significantly affect the safety or

effectiveness of any of its components in their quality system, in accordance with

“Convenience Kits Interim Regulatory Guidance.”

Assessment of “other

function” in the

premarket review

The biopsy needle guide kit is not evaluated as part of the premarket review, though the

safety and effectiveness demonstration of the device function-under-review related to the

compatibility of the biopsy needle tracking software with the biopsy needle guide kit is

evaluated.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/convenience-kits-

interim-regulatory-guidance.