Contains Nonbinding Recommendations 
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 DigitalHealth@fda.hhs.gov.  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 ocod@fda.hhs.gov.  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 
combination@fda.gov. 
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  Contains Nonbinding Recommendations 
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-
Guidance@fda.hhs.gov 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, ocod@fda.hhs.gov, 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, druginfo@fda.hhs.gov, or from the Internet at https://www.fda.gov/drugs/guidance-
compliance-regulatory-information/guidances-drugs.  Contains Nonbinding Recommendations 
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  Contains Nonbinding Recommendations 
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 FDAs 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.1  This guidance explains 
FDAs 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 
                                                          
1 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. 
1  Contains Nonbinding Recommendations 
review practices, and policies for FDAs 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.2 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 Devices3 and Standards Development and the Use of Standards in Regulatory 
Submissions Reviewed in the Center for Biologics Evaluation and Research.4
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys 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).5
Functions that fall within this definition are devices and, therefore, subject to FDAs oversight.  
FDAs regulation of devices is tailored based on risk.  For example: 
                                                          
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-
and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation. 
5 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). 
2 Contains Nonbinding Recommendations 
  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,6 good manufacturing practices,7 and adverse 
event reporting.8  
  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, FDAs guidance Policy for Device Software Functions and 
Mobile Medical Applications9 and General Wellness: Policy for Low Risk Devices.10
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. 
                                                          
6 Section 510 of the FD&C Act. 
7 Section 520(f) of the FD&C Act. 
8 Section 519 of the FD&C Act. 
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-
functions-and-mobile-medical-applications. 
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-
policy-low-risk-devices. 
3 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)-exempt11); 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 FDAs 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.12
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.  
                                                          
11 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. 
12 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). 
4 Contains Nonbinding Recommendations 
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.13  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 FDAs 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.14 Such other functions are not the subject of 
FDAs 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.15  
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.16  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 
                                                          
13 21 CFR 3.2(e). 
14 520(o)(2) of the FD&C Act. 
15 520(o)(2) of the FD&C Act. 
16 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. 
5 Contains Nonbinding Recommendations 
multiple function device product.17  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, FDAs 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-reviews 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.18  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.19
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 
                                                          
17 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). 
18 Please see the CDRH Premarket Review Submission Cover Sheet, available at https://www.fda.gov/medical-
devices/premarket-notification-510k/content-510k. 
19 During an inspection, upon FDAs 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. 
6 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-reviews 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. 
7 Contains Nonbinding Recommendations 
VI.  Assessing the Impact of Other Functions on the 
Device FunctionUnderReview
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. 
8 Contains Nonbinding Recommendations 
A.  Is There an Impact on the Safety or Effectiveness of the 
Device FunctionUnderReview 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 
9 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. 
10 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.20  
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. 
                                                          
20 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/. 
11 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 
FunctionUnderReview  
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 manufacturers 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 manufacturers 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.21
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 FDAs guidance The Least 
Burdensome Provisions: Concept and Principles.22
                                                          
21 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). 
22 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-
provisions-concept-and-principles. 
12 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-reviews performance), and the sponsor would like the positive impact 
to be considered in FDAs 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 use23 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 FDAs 
assessment of the device function-under-review. 
B.  Device Description  Description of Functions 
The device description should include an explanation of the devices 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. 
                                                          
23  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. 
13 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.24 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 Devices25) 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 
                                                          
24 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). 
25 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-
premarket-submissions-software-contained-medical-devices. 
14 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,26 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,27 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 FDAs 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 products 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
                                                          
26 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-
premarket-submissions-software-contained-medical-devices. 
27 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-
premarket-submissions-software-contained-medical-devices.
15 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.28 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 functions labeling (labeled positive impact), 
then reference the Deciding When to Submit a 510(k) for a Change to an Existing Device 
Guidance,29 Deciding When to Submit a 510(k) for a Software Change to an Existing Device 
Guidance,30 or Modifications to Devices Subject to Premarket Approval (PMA) - The PMA 
Supplement Decision-Making Process Guidance,31 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 functions 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 sponsors 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.32
                                                          
28 21 CFR 807.81(a)(3). 
29 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-
510k-change-existing-device. 
30 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-
510k-software-change-existing-device. 
31 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-
subject-premarket-approval-pma-pma-supplement-decision-making-process. 
32 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.  
16 Contains Nonbinding Recommendations 
IX.  Application of Other Device and Postmarket 
Requirements 
General control requirements33 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.34  
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 Products35 and the Office of 
Combination Products (OCPs) Postmarketing Safety Reporting for Combination Products 
webpage.36 Additional information on regulatory requirements and policies for combination 
products can also be found on OCPs webpage.37
                                                          
33 Sections 501, 502, 510, 516, 518, 519, 520(e), and 520(f) of the FD&C Act. 
34 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). 
35 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-
manufacturing-practice-requirements-combination-products. 
36 Available at https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-
reporting-combination-products.
37 Available at https://www.fda.gov/combination-products. 
17 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  The software app depends on the smart phone camera for the photos and depends on the 
function on the device  computing platform for the analysis. 
function-under-review 
Could there be increased    The output of the camera may not be adequate for detecting skin cancer in photos of 
risk or adverse effect of  suspicious lesions of moles, resulting in misdiagnosis. 
the other function on    The smart phones computing platform performance may not be adequate to support 
the device function-under- the software functions, including the algorithm intended to detect skin cancer in 
review  photos of suspicious lesions of moles. 
Documentation in the    Document testing outcomes that demonstrate that there are adequate computing 
premarket submission  resources (including screen size and resolution) and error handling to accommodate 
demonstrating that the  the common computing platform including that the built-in camera provides 
increased risk or adverse  adequate images. 
effect that could result    Document description of specific feature(s) with adequate testing outcomes that 
from the combination of  mitigate risk from software being used on a smart phone or inadequate camera. 
functions is mitigated    Documentation of specification for the use of the app with the camera and the 
computing platform. 
Documentation of  The sponsor should document the impact assessment and justification for their 
assessment in sponsors  determination regarding adverse impact of the other functions (camera output and 
quality system  smart phone computing platform) in accordance with the sponsors quality system. 
Assessment of other  The smart phone platform and camera are not evaluated as part of the premarket review, 
function in the  though the testing outcomes of the device function-under-reviews performance related 
premarket review  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. 
18 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  The handheld instrument depends on the docking station for charging and data transfer. 
function on the device 
function-under-review 
Could there be increased    Charging of the handheld instrument is necessary for device performance. 
risk or adverse effect of    The recharging of the battery introduces new hazardous situations for the instrument 
the other function on  itself. 
the device function-under-   Instrument may be affected by erroneous or nontrusted data transfer from the HIS 
review  system. 
Documentation in the    Demonstrate that appropriate mitigations were implemented to address hazards 
premarket submission  associated with battery charging. 
demonstrating that the    Document features authenticating data from trusted HIS system. 
increased risk or adverse 
effect that could result 
from the combination of 
functions is mitigated 
Documentation of  The sponsor should document the impact assessment and justification for their 
assessment in sponsors  determination regarding adverse impact of the other functions (docking station and 
quality system  interface software for data transfer) in accordance with the sponsors quality system. 
Assessment of other  The docking station and interface software are not evaluated as part of the premarket 
function in the  review, though the hazard mitigation for the docking station battery and authentication 
premarket review  features for data transfer are evaluated as part of the device function-under-reviews 
safety. 
19 Contains Nonbinding Recommendations 
Example: Traumatic brain injury determination 
Product  A product that analyzes a users 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  The device algorithm depends on the results of the questionnaire. 
function on the 
device function-
under-review 
Could there be    Inaccurate input of questionnaire results may impact the performance of the software. 
increased risk or    Computer performance may not be adequate to support the software functions including 
adverse effect of the  the algorithm intended to determine if the patient has TBI. 
other function on    The output of the questionnaire may not be adequate for determining if the patient has 
the device function- TBI. 
under-review 
Documentation in the    Demonstrate that appropriate mitigations were implemented to limit or minimize 
premarket submission  inaccurate input to the questionnaire. 
demonstrating that    Demonstrate that the algorithm includes features to detect inaccurate input that may 
the increased risk or  impact the performance of the software. 
adverse effect that    Testing outcomes demonstrating adequate computing resources (including screen size) 
could result from the  and error handling to accommodate the common computing platform. 
combination of    Description of specific feature(s) with adequate testing outcomes that mitigate risk from 
functions is mitigated  software being used on a common computing platform. 
Documentation of  The sponsor should document the impact assessment and justification for its determination 
assessment in  regarding adverse impact of the other functions (computing platform and questionnaire) in 
sponsors quality  accordance with the sponsors quality system. 
system 
Assessment of other  The computing platform and the questionnaire are not evaluated as part of the premarket 
function in the  review, though the impact to safety and performance related to using the computing platform 
premarket review  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. 
20 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  The Bluetooth functionality of the mobile platform provides connectivity to the worn device 
function on the  enabling remote control of the stimulation. 
device function-
under-review 
Could there be    The reliability and security of the Bluetooth connectivity could be compromised causing 
increased risk or  the TENS device to operate in an uncontrolled manner. 
adverse effect of the 
other function on 
the device function-
under-review 
Documentation in the    Appropriate demonstration of applicable wireless coexistence and EMC safety standards 
premarket submission  for the intended operating environment for the TENS worn part of the device to ensure 
demonstrating that  the reliability of the connection when used with the Bluetooth functionality. 
the increased risk or    Demonstrate that appropriate cybersecurity controls are included in the design and 
adverse effect that  implementation of the device function-under-review to ensure the reliability and security 
could result from the  of the connection. 
combination of 
functions is mitigated 
Documentation of  The sponsor should document the impact assessment and justification for their determination 
assessment in  regarding adverse impact of the other function (mobile platform Bluetooth transceiver and 
sponsors quality  connectivity) in accordance with the sponsors quality system. 
system 
Assessment of other  The mobile platform Bluetooth transceiver is not evaluated as part of the premarket review, 
function in the  though the evaluation outcomes of the device function-under-reviews safety and 
premarket review  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. 
21 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  As an integral part of the device that allows for a network connection, the Wi-Fi card has 
function on the  inherent risks associated with EMC and other wireless related risks (e.g., the vital 
device function- physiological parameters may be corrupted in transit to the EHR system), including 
under-review  cybersecurity risks. 
Could there be    The Wi-Fi card may affect both the performance and safety of the device or other devices 
increased risk or  in the area. 
adverse effect of the    The network connection may affect the safety of the device by introducing cybersecurity 
other function on  risks. 
the device function-   The misfunction of the interface software may impact the safety of the device as the vital 
under-review  physiological parameters may be corrupted in transit to the EHR system. 
Documentation in the    Demonstrate that appropriate cybersecurity controls were included in the design and 
premarket submission  implementation of the product. 
demonstrating that    Demonstrate that appropriate EMC and wireless testing was conducted and document 
the increased risk or  that the Wi-Fi card does not affect the performance of the monitor. 
adverse effect that 
could result from the 
combination of 
functions is mitigated 
Documentation of  The sponsor should document the impact assessment and justification for their determination 
assessment in  regarding adverse impact of the other functions (transmission software and Wi-Fi card) in 
sponsors quality  accordance with the sponsors quality system. 
system 
Assessment of other  The Wi-Fi card and transmission to the EHR are not evaluated as part of the premarket 
function in the  review, though the cybersecurity controls and performance testing of the device function-
premarket review  under-review are evaluated. 
22 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  The energy-delivering device function is not impacted by the mobile app or smart phone 
function on the  computing platform because the transmission of data cannot occur during energy delivery. 
device function-   Note: In this scenario, cybersecurity and radio frequency present risks that are 
under-review  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    Not applicable. 
increased risk or 
adverse effect of the 
other function on 
the device function-
under-review 
Documentation in the    Not applicable. 
premarket submission 
demonstrating that 
the increased risk or 
adverse effect that 
could result from the 
combination of 
functions is mitigated 
Documentation of  The sponsor should document the impact assessment and justification for their determination 
assessment in  regarding no impact of the other functions (mobile app and smart phone computing 
sponsors quality  platform) in accordance with the sponsors quality system. 
system 
Assessment of other  The mobile app and smartphone platform are not evaluated as part of the premarket review 
function in the  and no documentation on the other functions is necessary for premarket submission of the 
premarket review  device function-under-review. 
23 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  The biopsy needle guide kit is a convenience tray that combines a number of other ultrasound 
function on the  accessories that have already received 510(k) clearance (e.g., needle guide brackets, sterile 
device function- ultrasound gel, sterile probe covers) or are class I 510(k)-exempt (e.g., sterile tray, drape 
under-review  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    The biopsy needle tracking software may not be compatible with all ultrasound needle 
increased risk or  biopsy kits.  Incompatibility may lead to inaccurate or imprecise guiding of the needle to 
adverse effect of the  the target area. 
other function on 
the device function-
under-review 
Documentation in the    For biopsy needle tracking software intended to be compatible with various ultrasound 
premarket submission  needle biopsy kits, performance testing should be provided showing that the accuracy 
demonstrating that  and precision meets the specifications and requirements for the subject device.  For 
the increased risk or  example, data can show that the software, when used with the biopsy guide kit, guides 
adverse effect that  the needle to the target area within +/- 0.5 mm, which is substantially equivalent to the 
could result from the  predicate device. 
combination of 
functions is mitigated 
Documentation of  The sponsor should document the impact assessment and justification for their determination 
assessment in  regarding potential adverse impact of the other function (biopsy needle guide kit) in 
sponsors quality  accordance with the sponsors quality system.  The sponsor should document that any further 
system  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.38
Assessment of other  The biopsy needle guide kit is not evaluated as part of the premarket review, though the 
function in the  safety and effectiveness demonstration of the device function-under-review related to the 
premarket review  compatibility of the biopsy needle tracking software with the biopsy needle guide kit is 
evaluated. 
                                                          
38 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/convenience-kits-
interim-regulatory-guidance. 
24