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Multiple Function Device Products: 

Policy and Considerations 

Final Guidance

Sonja Fulmer, Ph.D.

Assistant Director for Digital Health Policy

Division of Digital Health

Office of Strategic Partnerships and Technology Innovation 

Center for Devices and Radiological Health (CDRH)

September 10, 2020
3

Agenda

This presentation will cover:

̶ Background 

̶ Definitions

̶ Summary of Final Guidance

̶ Additional resources
4

Webinar Objectives

After this webinar, you should be familiar with:

̶ How the FDA defines function and other key terms for purposes of this 

guidance

̶ The FDA’s regulatory approach and policy for all multiple function device 

products

̶ Considerations for the design and risks of multiple function device 

products

̶ How the FDA intends to assess the impact of non-device software 

functions/“other functions” on the safety and effectiveness of a device 

function

̶ Premarket submission content for a device function-under-review
5

Functionality Focused Approach to Software

Risk Based 

Functionality 

Focused

Platform 

Independent

Promote 

Innovation

Narrowly 

Tailored

Promote 

Patient 

Engagement

Protect 

Patient 

Safety
6

Recognition of low risk

Digital Health products 

21st Century Cures Act:

Building on FDA’s Digital Health Policy

Codification of existing 

enforcement discretion 

policies

Applying a least 

burdensome approach for 

device regulation
7

• Defines software functions that are not devices

• States that the FDA shall not regulate non-device functions of a product with 

multiple functions – but can consider the impact of non-device functions on the device 

functions

• Provides for the FDA regulation of software functions that are excluded from the 

device definition by the Cures Act, if the FDA finds that it would be reasonably likely 

to have serious adverse health consequences (substantive and procedural criteria must 

be met)

• Exclusions from device definition do not include software used in the manufacture and 

transfusion of blood and blood components to assist in the prevention of disease in 

humans

Overview of Cures Act Software Provisions 

(Section 3060)
8

21st Century Cures Act (Section 3060) and FDA Policies

Amended the definition of “device” in the Federal Food, Drug, and 

Cosmetic Act to exclude certain software functions intended for...

FDA policies 

affected/codified

Administrative Functionality

(B) General Wellness

(C) Electronic Patient Records

(D) Transfer, Store, Convert formats, 

Display related information 

(E) Clinical Decision Support

(A) Administrative support

FDA Policy for Low-Risk General 

Wellness Products

Health Management Functionality

Policy for Clinical Decision Support 

Software included in 

Health Management Functionality

Medical Device Data System 

(MDDS)

*Addition of 520(o)(2) describes the regulation and assessment of a software product with multiple functions

(*) Multiple Function Device Products Multiple Function Device Products: 

Policy and Considerations
9

• 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.

21st Century Cures Act: Added Section 

520(o)(2) to the FD&C Act
10

Policy: Premarket Review of Multiple Function Device Products

Considerations for Multiple Function 

Device Products

Content of a Premarket Submission for Device Function-Under-Review 

Assessing the Impact of “Other 

Functions” on the Device FunctionUnder-Review

Sections Covered in Multiple Function Guidance
11

Definitions*

Function A distinct purpose of a product 

Device Function A function that meets the definition of a device under 

section 201(h) of the FD&C Act

Other Function A function that:

̶ does not meet the definition of a device;

̶ meets the definition of device, but is not subject to 

premarket review (for example, 510(k)-exempt); or 

̶ meets the definition of device, but for which the FDA 

has expressed its intention not to enforce compliance 

with applicable regulatory controls.

Device 

Function-UnderReview

A function for which the FDA is conducting a premarket 

review 

Multiple 

Function Device 

Product

A product that contains at least one device function and 

at least one other function.

Function could be the intended 

use or a subset of the intended 

use of the product. 

Examples

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. 

*These terms are used for the purposes of this guidance. 
12

• 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 

• This guidance expands that policy to apply to the assessment of all multiple 

function device products, whether those functions are software-based, 

hardware-based, or both. 

• This guidance applies in the premarket review context: a multiple function 

device product is a product with at least one device function-under-review and 

one “other function.” 

• This guidance applies in the postmarket context: a multiple function device 

product is a product with at least one device function that is the focus of the 

FDA’s oversight and one “other function.” 

Guidance Scope
13

• “Other functions” are not the subject of the FDA’s review 

simply because they are part of a multiple function 

device product. 

• However, the 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.1

Software Example:

A general-purpose computing platform is not 

regulated by the FDA. 

The FDA may assess its impact on the safety and 

effectiveness of a device function-under-review, 

such as a mobile medical application. 

Hardware Example: 

Product includes an intragastric balloon subject to 

premarket approval and an endoscope accessory 

that is 510(k)-exempt (for example, an endoscope 

guidewire). 

The FDA may assess the impact of the endoscope 

accessory on the safety and effectiveness of the 

intragastric balloon. 

1 Section 520(o)(2) of the FD&C Act

Policy: Premarket Review of Multiple Function Device 

Products

Other Function

̶ does not meet the definition of 

a device;

̶ meets the definition of device, 

but is not subject to premarket 

review (for example, 510(k)-

exempt); or 

̶ meets the definition of device, 

but for which the FDA has 

expressed its intention not to 

enforce compliance with 

applicable regulatory controls.
14

Positive effects: 

enhance safety and 

effectiveness (for 

example, improve 

processing speed)

Adverse effects: 

adversely affect 

performance (for 

example, slow 

computation time)

Policy: Premarket Review of Multiple Function Device Products

Conduct Risk Assessment: Determine if an “other function” impacts the 

safety or effectiveness of the device function-under-review

Include in a Premarket 

submission:

information related to 

impacts of “other 

functions” only if they... 

Could positively impact the 

device function-under-review 

and

this fact will be represented in 

the device function-underreview’s labeling (“labeled 

positive impact”)

Could negatively impact the 

device function-under-review 
15

Policy: Premarket Review of Multiple Function Device Products

Considerations for Multiple Function 

Device Products

Content of a Premarket Submission for Device Function-Under-Review 

Assessing the Impact of “Other 

Functions” on the Device FunctionUnder-Review

Sections Covered in Multiple Function Guidance
16

•The device function-under-review should be separated from “other 

functions” in its design and implementation (for example, logical 

separation, architectural separation, code, and data partitioning).

•Architecture decisions early in the design cycle can facilitate 

optimal separation and support segregation necessary for risk 

control.

•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. 

•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. 

Considerations for Multiple Function Device Products

Separation in Design and Implementation of the 

Device Function

Separation and 

Architecture

Risk Analysis
17

Considerations for Multiple Function Device Products

Impact of “Other Functions”:

Manufacturer of a multiple function device product should consider the following regarding all “other 

functions” of the product: 

– Role of the “other function” in the device function-under-review’s performance;

– 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.”
18

Policy: Premarket Review of Multiple Function Device Products

Considerations for Multiple Function 

Device Products

Content of a Premarket Submission for Device Function-Under-Review 

Assessing the Impact of “Other 

Functions” on the Device FunctionUnder-Review

Sections Covered in Multiple Function Guidance
19

Assessing the Impact of “Other Functions” on the 

Device Function-Under-Review

Start

Is there an impact 

on the Safety or 

Effectiveness of the 

Device FunctionUnder Review as a 

Result of the “Other 

Function?” (Section 

VI.A)

Could the Impact 

Result in Increased 

Risk or Have an 

Adverse Effect on 

Performance? 

(Section VI.B)

Could the Impact 

Result In a Positive 

Impact that the 

Sponsor Intends to 

Include in the 

Labeling?

Document the impact assessment and 

justification for determination of impact 

of the “other function(s)” on the device 

function-under-review in accordance 

with your quality system. (Section VII)

Yes

Yes

Yes

No

No No

Include the appropriate 

documentation in the 

premarket submission. 

(Section VII)

In addition, document the 

impact assessment and 

justification for 

determination of impact of 

the “other function(s)’ on the 

device function-under-review 

in accordance with your 

quality system. (Section VII)
20

The premarket assessment of a product with multiple functions is summarized 

in a two-step process:

Assessing the Impact of “Other Functions” on the 

Device Function-Under-Review

A) Is There an Impact on the 

Safety or Effectiveness of the 

Device Function-UnderReview as a Result of the 

“Other Function?”

B) Could the Impact Result in 

Increased Risk or Have an 

Adverse Effect on 

Performance, that is, a 

Negative Impact? 

• Impacts to Safety

• Impacts to Effectiveness
21

• 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? 

(For example, 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?”

Examples of Questions to Consider while answering... 

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

Result of the “Other Function?”

This is not a comprehensive list of considerations. Manufacturers should conduct their own risk assessments. 
22

Following examples help illustrate impacts to safety:

• 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.

– A “hazardous situation” exists when there is exposure to a hazard (that is, 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.

Examples of Questions to Consider while answering... 

B) Could the Impact Result in Increased Risk or Have an Adverse Effect on 

Performance, that is, a Negative Impact? 

This is not a comprehensive list of considerations. Manufacturers should conduct their own risk assessments. 
23

Following examples help illustrate adverse impacts to effectiveness:

• 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.”

Examples of Questions to Consider while answering... 

B) Could the Impact Result in Increased Risk or Have an Adverse Effect on 

Performance, that is, a Negative Impact? 

This is not a comprehensive list of considerations. Manufacturers should conduct their own risk assessments. 
24

Policy: Premarket Review of Multiple Function Device Products

Considerations for Multiple Function 

Device Products

Content of a Premarket Submission for Device Function-Under-Review 

Assessing the Impact of “Other 

Functions” on the Device FunctionUnder-Review

Sections Covered in Multiple Function Guidance
25

21 CFR 820.30(g):

Manufacturer must establish and maintain procedures for validating its device design. 

Design validation includes software validation and risk analysis, where appropriate. 

Multiple Function Device Products: Manufacturers should include an impact assessment 

and rationale for 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 manufacturer’s quality system. 

Content of a Premarket Submission for Device 

Function-Under-Review 

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

Impact assessment should include: 
26

Considerations for “Other Function(s)” in Premarket 

Submission Content for Device Function-Under-Review

Indications for Use Not needed unless sponsor would like the positive impact of the “other 

function(s)” to be considered by the FDA.

Device Description 

– Description of 

Functions

Include description of “other function(s)” that could adversely impact the 

device-function-under-review and how it is impacted.

Include the same information for positive impacts if included in label.

Labeling Include description of the “other function(s)” adequate to ensure 

appropriate use of the device

Architecture and 

Design

Include architecture and design documents that provide adequate detail 

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

device function-under-review when the latter includes software.

Device Hazard 

Analysis

Include results of a risk-based assessment of any potential adverse 

impact or labeled positive impact of the “other function(s)” .

Requirements and 

Specifications

Include adequate detail to describe any expected relationship, utility, 

reliance, or interoperability with any “other function.”

Performance 

Testing

Include performance testing results that demonstrate that the impact of 

the “other function(s)” to safety or effectiveness is appropriately 

addressed.

If the “other function” does not 

impact the device function-underreview then the premarket 

submission for the device functionunder-review does not need to 

include the documentation 

described to the right. However, 

the labeling should include a 

description of the “other 

function(s)” adequate to ensure 

appropriate use of the device

If the “other function” could 

adversely impact the device 

function-under-review, or if the 

device function-under-review could 

be positively impacted by the 

“other function” 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 documentation 

described to the right.
27

Modifications to the “other function(s)” of a multiple function device product should be 

assessed to determine if the change could significantly impact the safety or effectiveness of 

the device function that was the subject of the FDA’s review. 

At this time, the FDA does not intend to enforce the applicable premarket submission 

requirements for modifications of “other function(s)” that could positively impact the device 

function unless the positive impact is included in the labeling.

Modifications to “Other Function” of Multiple Function 

Device Product

Reference “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). 
28

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.

Examples

1) Device functions in multiple function 

device products must comply with design 

control requirements under the Quality 

System regulation (21 CFR Part 820). 

2) In accordance with 21 CFR 803.50, the 

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.

Combination Products

For more information on current good 

manufacturing and postmarketing

safety reporting requirements and 

policies applicable to combination 

products, see 21 CFR Part 4, the FDA 

“Current Good Manufacturing Practice 

Requirements for Combination 

Products” and the Office of 

Combination Product’s (OCP’s) 

“Postmarketing Safety Reporting for 

Combination Products” webpage.
29

Examples: Assessing the Impact of “Other Functions” 

on the Device Function-Under-Review

Start

Is there an impact 

on the Safety or 

Effectiveness of the 

Device FunctionUnder Review as a 

Result of the “Other 

Function?” (Section 

VI.A)

Could the Impact 

Result in Increased 

Risk or Have an 

Adverse Effect on 

Performance? 

(Section VI.B)

Could the Impact 

Result In a Positive 

Impact that the 

Sponsor Intends to 

Include in the 

Labeling?

Document the impact assessment and 

justification for determination of impact 

of the “other function(s)” on the device 

function-under-review in accordance 

with your quality system. (Section VII)

Yes

Yes

Yes

No

No No

Include the appropriate 

documentation in the 

premarket submission. 

(Section VII)

In addition, document the 

impact assessment and 

justification for 

determination of impact of 

the “other function(s)’ on the 

device function-under-review 

in accordance with your 

quality system. (Section VII)
30

Example: A smart phone software application (app) that detects 

skin cancer from photos of suspicious lesions of moles

Start

Is there an impact on 

the Safety or 

Effectiveness of the 

Device Function-Under 

Review as a Result of 

the “Other Function?” 

(Section VI.A)

Device function-under-review:

• Software app that detects skin cancer

“Other function:”

• Smart phone computing platform 

• Camera on the computing platform 

Yes
31

Start

Is there an impact on 

the Safety or 

Effectiveness of the 

Device Function-Under 

Review as a Result of 

the “Other Function?” 

(Section VI.A)

Yes

Could the Impact 

Result in Increased 

Risk or Have an 

Adverse Effect on 

Performance? 

(Section VI.B)

Yes

The software app depends on 

the smart phone camera for the 

photos and depends on the 

computing platform for the 

analysis.

Example: A smart phone software application (app) that detects 

skin cancer from photos of suspicious lesions of moles

Device function-under-review:

• Software app that detects skin cancer

“Other function:”

• Smart phone computing platform 

• Camera on the computing platform 
32

Start

Is there an impact on 

the Safety or 

Effectiveness of the 

Device Function-Under 

Review as a Result of 

the “Other Function?” 

(Section VI.A)

Yes

Could the Impact 

Result in Increased 

Risk or Have an 

Adverse Effect on 

Performance? 

(Section VI.B)

The software app depends on 

the smart phone camera for the 

photos and depends on the 

computing platform for the 

analysis.

Include the appropriate 

documentation in the 

premarket submission. 

(Section VII)

In addition, document the 

impact assessment and 

justification for 

determination of impact of 

the “other function(s)’ on the 

device function-under-review 

in accordance with your 

quality system. (Section VII)

Yes

Example: A smart phone software application (app) that detects 

skin cancer from photos of suspicious lesions of moles

Device function-under-review:

• Software app that detects skin cancer

“Other function:”

• Smart phone computing platform 

• Camera on the computing platform 
33

Example: 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

Start

Is there an impact on 

the Safety or 

Effectiveness of the 

Device Function-Under 

Review as a Result of 

the “Other Function?” 

(Section VI.A)

Device function-under-review:

• Energy-delivering aesthetic device

“Other function:”

• Mobile app that integrates with device and 

transfers treatment parameter data to a cloudbased storage system – no real-time transmission 

• Smart phone computing platform

No
34

Example: 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

Start

Is there an impact on 

the Safety or 

Effectiveness of the 

Device Function-Under 

Review as a Result of 

the “Other Function?” 

(Section VI.A)

Device function-under-review:

• Energy-delivering aesthetic device

“Other function:”

• Mobile app that integrates with device and 

transfers treatment parameter data to a cloudbased storage system – no real-time transmission 

• Smart phone computing platform

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

Document the impact assessment and 

justification for determination of impact 

of the “other function(s)” on the device 

function-under-review in accordance 

with your quality system. (Section VII)

No
35

Example: Pulsed ultrasound and biopsy needle guide kit

Start

Is there an impact on 

the Safety or 

Effectiveness of the 

Device Function-Under 

Review as a Result of 

the “Other Function?” 

(Section VI.A)

Device function-under-review:

• General purpose diagnostic 

ultrasound system

• Biopsy needle tracking functionality

“Other function:”

• 510(k)-exempt biopsy needle guide 

kit

Yes
36

Example: Pulsed ultrasound and biopsy needle guide kit

Start

Is there an impact on 

the Safety or 

Effectiveness of the 

Device Function-Under 

Review as a Result of 

the “Other Function?” 

(Section VI.A)

Yes

Could the Impact 

Result in Increased 

Risk or Have an 

Adverse Effect on 

Performance? 

(Section VI.B)

Yes

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.

Device function-under-review:

• General purpose diagnostic 

ultrasound system

• Biopsy needle tracking functionality

“Other function:”

• 510(k)-exempt biopsy needle guide 

kit
37

Example: Pulsed ultrasound and biopsy needle guide kit

Start

Is there an impact on 

the Safety or 

Effectiveness of the 

Device Function-Under 

Review as a Result of 

the “Other Function?” 

(Section VI.A)

Yes

Could the Impact 

Result in Increased 

Risk or Have an 

Adverse Effect on 

Performance? 

(Section VI.B)

Yes

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.

Include the appropriate 

documentation in the 

premarket submission. 

(Section VII)

In addition, document the 

impact assessment and 

justification for 

determination of impact of 

the “other function(s)’ on the 

device function-under-review 

in accordance with your 

quality system. (Section VII)

Device function-under-review:

• General purpose diagnostic 

ultrasound system

• Biopsy needle tracking functionality

“Other function:”

• 510(k)-exempt biopsy needle guide 

kit
38

• The FDA recognizes that regulations play a crucial role in the development of 

technologies that could significantly impact everyday life. The FDA believes that 

our approach to regulating these products should foster innovation while 

protecting public health.

• This guidance is aimed at clarifying the FDA’s policy for all multiple function 

products that contain at least one device function. 

• The final guidance incorporates feedback from the public comments to clarify and 

provide examples to describe the FDA’s policy on products with multiple 

functions.

• The guidance intends to provide clarity for manufacturers, the FDA’s staff, and 

other stakeholders on the medical software provisions of the 21st Century Cures 

Act, which is part of the FDA's long-term Digital Health Innovation Action Plan.

Summary
39

Web link to “Multiple Function Device Products: Policy and Considerations”: 

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/multiple-function-device-products-policy-and-considerations

If you are unsure whether your product that contains software functions 

would be considered a multiple function device, please contact 

DigitalHealth@FDA.HHS.gov

Resources
40

Questions?

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording 

will be available at:

http://www.fda.gov/training/cdrhlearn Under the 

Heading: How to Study and Market Your Device; Sub 

heading: Cross-Cutting Premarket Policy 

Please complete a short survey about your FDA CDRH webinar 

experience. The survey can be found at www.fda.gov/CDRHWebinar

immediately following the conclusion of the live webinar