FDA WEBINAR

Moderator: IRENE AIHIE

09-10-20/11:00 a.m. ET

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FDA Webinar: Multiple Function Device Products:

Policy and Considerations

Moderator: Irene Aihie

September 10, 2020

11:00 a.m. ET

Coordinator: Welcome and thank you for standing by. At this time, all participants are in a 

listen-only mode until the question and answer session of today's conference. 

At that time, you may press star one on your phone to ask a question. 

I would like to inform all parties that today's call is being recorded. If you 

have any objections, you may disconnect at this time. 

I would now like to turn to the conference over to Ms. Irene Aihie. Thank 

you. You may begin.

Irene Aihie: Thank you. Hello. And welcome to today's FDA Webinar. I am Irene Aihie 

of CDRH's Office of Communication and Education. On July 29, 2020, the 

FDA issued its final guidance, Multiple Function Device products: Policy and 

Considerations. This final guidance incorporates feedbacks from public 

comments to clarify and provide examples that describe the FDA's policy on 

product with multiple function. It also describes medical software positions of 

the 21s Century Cures Act as part of the FDA's long-term Digital Health 

Innovation Action Plan and identifies the principles, premarket review 

practices and policies for the FDA's regulatory assessment of products with 

multiple function that include at least one device function. 

Today, Sonja Fulmer, Assistant Director for Digital Health Policy in the 

Office of Strategic Partnership and Technology Innovation, in the Division of 

Digital Health here in CDRH will present an overview of the guidance. She is 
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joined by other centers subject matter expert to assist with the Q&A. 

Following the presentation, we will open the lines for your questions related 

to information provided during today's discussion. 

Now, I give you Sonja. 

Sonja Fulmer: Good morning. Thank you for that introduction Irene and thank you to 

everyone joining online for today's webinar on the multiple function device 

products guidance. Next slide.

Today, I'll start by providing background information on the software 

provisions of the 21st Century Cures Act. Then, we'll discuss the definitions

of terms that we use in the guidance in this webinar before moving into the 

details of the final guidance. We'll conclude with some additional resources 

that you can access if you have further questions about this guidance. 

Next slide.

At the end of this webinar, you should be familiar with the few key terms 

including how we define functions for the purposes of this guidance. You 

should understand FDA's regulatory approach and policy for all multiple 

function device products. You'll also be familiar with considerations you 

should keep in mind for the design and risks of these products. You should 

understand how FDA intends to assess the impacts of non-device functions or 

other functions on the safety and effectiveness of a device function in addition 

to knowing what premarket submission content is recommended for a device 

function under review that is part of a multiple function device product. Next 

slide.

This slide describes the basis of FDA's regulation of software. First and 

foremost, we take a risk based approach to the regulation software. 

Importantly and especially for this guidance, that approach is focused on a 

specific functions of devices, and the regulation is narrowly tailored to the risk 

of the devices. These approaches are platform independent, meaning that it 

does not matter on what type of platform the software function is deployed 
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from a general purpose competing platform to a smartphone, we apply our 

regulation based on the function. 

This is intended to promote innovation and patient engagement with these 

digital health products. And ultimately, to protect patient safety. The 

software provisions of the 21st Century Cures Act built from this approach to 

the regulation of software. Next slide.

The Cures Act recognized that there are certain digital health products that are 

low risk. Many of these products were under enforcement discretion policies 

prior to the enactment of the Cures Act which codified many of those existing 

policies by revising the definition of device to exclude certain low software 

functions. This enabled FDA to apply a least burdensome approach for device 

regulation. Next slide.

As I mentioned, the Cures Act defined software functions that are not device 

functions. It also states that FDA shall not regulate non-device software 

functions of a product with multiple functions but we can consider the impact 

if this non-device functions on the safety and effectiveness of the device 

functions. Next.

And as you know, this is the topic -- this topic is the focus of the guidance 

we're discussing today. The Cures Act also provides for the FDA regulation 

of software functions that are excluded from the device definition if we find 

that those functions will be reasonably likely to have serious adverse health 

consequences. 

In order to do that, there are certain substance and procedural criteria that 

must be met. And these exclusions from the device definition don’t include 

software functions involved in the manufacture and transfusion of blood and 

blood components to assist in the prevention of disease in humans. Next 

slide.

We've often described the Cures Act as codifying some existing FDA policies,

including those for software functions intended for administrative support, 

general wellness, electronic patient records, those intended for the transfer 
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storage, converting -- conversion of formats and display of medical device 

data, and certain clinical decision support functions. Next. 

What we have talked about last is the regulation of multiple function device 

products. The Cures Act was also a recognition of our approach to those 

types of products. In that FDA does not regulate non-device functions but we 

can consider the impacts those functions have on the devices we do regulate. 

Next slide.

Here is the full text of a multiple function statutory provision which was 

added to Section 520(o) of the Federal Food, Drug and Cosmetic Act. Simply 

put this provision says that FDA does not regulate non-device software 

functions and that we can assess the impacts of those software functions on 

device functions. In the guidance we're discussing today, we describe how 

that works in practice. Next slide. And next.

The guidance describes the overarching policy of premarket review of 

multifunction device products. Next. It also describes what manufacturers

should consider for those products. Next. The questions to ask when 

assessing the impact on the device function. Next. And the recommend the 

content of a premarket submission for these multiple function device products. 

Next. 

So before we get into those sections, we're going to go over some definitions 

of a few terms that we use for the purposes of this guidance. First the term 

function is the distinct purpose of a product. It could be the intended use or 

subset of the intended use. By way of a simple example, a product could have 

just one function: to analyze data. 

A multiple function product could be intended to store, transfer and analyze 

data and those are three functions. A device function is a function that meets 

the definition of a device according to Section 201(h). An other function can 

be a function that does not meet the definition of device or it meets the 

definition of device but it's not subject to premarket review like a 510(k) 

exempt device. Or it can be a function that meets the definition of device but 

is one that FDA has expressed its intent not to enforce compliance with the 
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applicable regulatory controls. That's what we often describe as a function 

under enforcement discretion. 

A device function under review is a clunky term for the function for which 

FDA is conducting a premarket review. And a multiple function device 

product is a product that contains at least one device function and at least one 

other function. Next.

The Cures Act multiple function provision is limited to multiple function 

products that contain non-device software functions. However, the principles 

in this guidance apply to the assessment of all multiple function device 

products, whether these functions are software-based, hardware-based, or 

both. 

In the premarket review context, this means a multiple function device 

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

other function. And although the guidance mostly focuses on premarket, the 

principals still apply in the post-market context. 

In that 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. So for example in the post-market context, during a -- during an 

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

principles of these guidance would apply to a 510(k) exempt device function. 

Next. Next.

Irene Aihie: Sonja, do you see my slides progressing?

Sonja Fulmer: Yes. Sorry. I think we're now on slide 13. I think I may have had a delay on 

my end. So appreciate that.

So, we are now onto the Policy for Pre-market Review of Multiple Function 

Device Products. So shifting back to the premarket context, to summarize the 

overarching policy of the guidance, we've just gone over the definition of 

other functions showing here again on the right. And these other functions are 

not the subjects of FDA's reviews simply because they're part of a multiple 

function device product. That is, if FDA is conducting a premarket review of 
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a multiple function device product and that product contains a function that is 

not a device, we do not review that non-device function. However, we can 

assess the impact of these other functions when we are conducting that 

premarket review. 

So for example, a software based multiple function device products which 

could be a general purpose computing platform itself is not regulated by FDA. 

However, FDA may assess its impacts on the safety and effectiveness of a 

mobile medical apps that is a device that runs on that computing platform. 

Hardware example is a product that includes an intragastric balloon subject to 

PMA and an endoscope accessory that is 510(k) exempt like a guide wire. 

FDA may assess the impacts of the endoscopic accessory on the safety and 

effectiveness of the intragastric balloon. Next.

So next this guidance describes what this means in practice and what should 

be documented in a premarket submission. First, manufacturer should 

conduct a risk assessment to determine if the other functions impacts the 

safety and effectiveness of the device function under review. Those other 

functions may have positive effects that enhance the safety and effectiveness 

of the device function or they may have adverse effects that adversely affects 

performance and could negatively impact the device functions under review. 

Manufacture should include information related to these other functions and 

their premarket submissions only if the positive effects are represented in the 

device’s labeling: what we call a labeled positive impact. Or if the other 

function could negatively impact the device function under review. Next.

Now that we've covered the overall premarket policies for multiple function 

device products, we'll talk about some considerations for multiple function 

device products. Next.

An important consideration of these products is separation in the design and 

implementation of the device function under review from the other function. 

This could be accomplished through logical separation, architectural 

separation, code and data partitioning. 
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Making these architecture decisions early in the design cycle and facilitate 

option separation and support separation that is necessary for the appropriate 

risk control. Documenting the results of a thorough risk analysis of the impact 

of other functions and mitigation strategies employed is a critical component 

of a risk management process. 

When separation is not achievable, the interconnection and interdependencies 

between the device function under review and other function should be 

explained and included in the hazard analysis, and appropriate control should 

be created to reduce the adverse impact of the connectivity on the safety and 

effectiveness of the device function under review. 

The higher the degree of separation, the easier it is to independently review 

the safety and effectiveness of the device function under review. And 

separation will also increase the likelihood that the device function under 

review did not it is not dependent on the other functions in the product. This

separation is especially important when considering cyber security risk and 

mitigations. Next.

There are few considerations in a manufacturer of a multiple function device 

product to keep in mind regarding the impacts of other functions. The role of 

that other function in the device function under review’s performance and the 

limitations of the device function under review when using the other function. 

The manufacture should develop appropriate resource specification to ensure 

there's minimal impact in the other functions and they should consider what 

the actions the end user may take when using these functions. 

And finally, the manufacture should identify, evaluate, and mitigate any 

additional risk that results in the combination of the other functions with the 

device function under review. Next.

Next, we'll discuss how FDA may assess the impacts of the other function on 

the device function under review. Next. Section 6 of the guidance includes a

flow chart reproduce here with color to guide this assessment. And later we’ll

walk through a few examples with the flow chart. Next.
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To boil it down a little further, this assessment is summarized in a two-step 

process. First we ask, is there an impact on the safety or effectiveness of the 

device function under review as a result of other function. And if there is an 

impact, could the impact result in an increase risk or have an adverse effect on 

performance of the device function under review. What we call a negative 

impact. 

For positive impacts, the manufacture should identify the beneficial impact of 

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 would have failed to operate as intended. 

For negative impacts, the manufacture should identify whether there could be 

increase risk or an adverse effect on performance due to the combination of 

the other function with the device function under review. 

For examples of multiple function and software device products and 

explanations of the assessment of how other function impact the device 

functions impact the device function under review, please see Appendix 1 in 

the guidance. Next.

When assessing the impact of other functions on -- on the device function 

under review, it's important to consider the various relationships between the 

functions that may exist in a multiple function device products. 

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 such as mobile medical application has a 

relationship with the computing platform on which it is executed. The 

computing platform may or may not have an impact on the safety or 

effectiveness of the software device function. 

Here are a few examples of the questions to consider when answering the first 

question which is, is there an impact on the safety and effectiveness of the 

device function under review as a result of the other function. I'll note that 
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this is not a comprehensive list and there may be other questions 

manufacturers should ask themselves when conducting the risk assessment. 

To answer this question, we consider whether the other function provides 

critical input data that is used for the device function under review or if the 

device function under review relies on the result from other function. We also 

consider whether the other function may affect the memory requirements or

processing time that’s important for the performance of the device function 

under review. 

So once we've thought through these considerations and if the answer to the 

question, is there an impact, is no, then the manufacture should document this 

impact assessment and the justification for their determination. If the answer 

is yes, we proceed to determine the extent of the impacts with the next 

question. Next slide.

So to determine the extent of the impacts, we consider whether the impact 

could result an increase risk or have an adverse effect on performance. We 

can break down the second question to two parts, the possible impacts to 

safety and the possible impact to effectiveness. The impacts of safety are 

often impacts associated with risk. 

For example the other function could introduce a new hazardous situation or 

increase the severity of harm associated with the hazardous situation. The 

other function could be a risk control measure or it could impact a risk control 

measure for the device function under review. Next.

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. For example, 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. Or the performance of the 

device function under review fails to meet the specified performance levels

due to the other function. Next.
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So next, we'll discuss recommendations for content of a premarket submission 

for a device function under review. Next slide.

As described in 21 CFR 820.30(g), a manufacturer must establish and 

maintain procedures for validating its device design. This validation includes 

software validation and risk analysis. And for multiple function device 

products, manufacturers should include an impact assessment that describes 

the information we've just reviewed in order to document the manufacturer’s 

determination of the impact of the other function. Next slide.

This slide details what documentation should be included in the premarket

submission for a device function under review. If the other function is 

determined to have an adverse impact or if the sponsor would like to include a 

positive impact of the other function on the device function under review, then 

the premarket submission should include the information in this table. 

If the other function does not impact the device function under review, then 

the premarket submission does not need to include this information. 

However, I'll note that the labeling for the device function under review 

should include a description of the other function, adequate to ensure the 

appropriate use of the device. 

So let's talk through this table. Indications for use does not need to include 

the other function unless the sponsor wants FDA to consider a positive impact 

with the other function. The device description should include how the other 

function adversely impacts the device function under review or how a labeled

positive impact could positively impact the device function under review. 

As I mentioned, the labeling should always include the description of the 

other function adequate to ensure appropriate use of the device and that's even 

if the sponsor determines there’s no impact to the safety or effectiveness of 

the device function under review. 

The architecture and design documentation should explain how the other 

function interacts with the device function under review and the hazard 
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analysis should describe the results of the risk based assessment of these 

impacts. 

The requirements and specifications should describe the relationship and 

interoperability of the device function under review with the other function 

and the performance testing results should demonstrate that the impacts of 

safety and effectiveness are addressed. Next slide.

The guidance also describes what assessment should be made if there is a 

modification to the other function of a multiple function device product. In 

essence, this assessment should follow the modifications policy for devices 

which is that if the change could significantly impact the safety or 

effectiveness of the device function that was a subject of FDA review then

you should reference the appropriate modifications guidance seen on this slide

to help determine if a new premarket submission is necessary. Next slide.

Although this guidance mostly focuses on premarket review of multiple 

function device products. It does include a short section on the applicablity of 

other device and post market requirements. General control requirements 

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

requirements and those are that 510(k) exempts. 

For example, device functions must comply with design control requirements. 

Another example is that -- that if there were an adverse events for multiple 

function device products and the manufacturer is aware of information that the 

device function may have caused or contributed to a death or serious injury 

then the manufacturer -- then the manufacturer should investigate the cause of 

that adverse event and submit an AER. 

This guidance doesn’t change any other requirements for combination 

products. Combination product that include multiple function device products 

have additional requirements such as those requirements applicable to the 

drug or biologic constituent part. Next slide. 

Finally, we're going to use this flowchart to walk through a couple examples

from the guidance. Next slide. We'll start with the first example on page 18 
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of the guidance. This is a smartphone app that detects skin cancer from 

photos of suspicious lesions of moles. 

In this example the device function under review is the software app that 

detects skin cancer. And the other functions are the smartphone computing 

platform and the camera on computing platform. In answering the question --

the first question of the flowchart, we determined that the software app 

depends on the smartphone camera for the photos and depends on the 

computing platform for the analysis. 

Next. So we answer yes to the first question and proceed to the next question. 

Next slide. 

We are asking whether that impact could result in an increased risk or have an 

adverse effect on performance. And the software app depends on the 

smartphone camera so the photos depends on a computing platform for the 

analysis. The output of the camera may not be adequate for detecting skin 

cancer and photos of sufficient lesions of moles resulting in this diagnosis.

And the smartphones computing platform performance may not be adequate 

for the software functions including the algorithm intended to detect skin 

cancer and photos of suspicious legions of moles. 

So we answer yes and determine that we need to -- next slide. While waiting 

for the next slide to get there. Yes.

So we need to include appropriate documentation and the submission to the 

documents that impact assessment and the determination we have reached. So 

there needs to be documentation in the premarket submission demonstrating 

that the increase risk or adverse effects that could result in the combination of 

functions is mitigated. And we'd expect that documents testing outcomes that 

demonstrate that there are adequate computing resources including screen size 

and resolution and error handling to accommodate the common computing 

platform including that the built-in camera provides adequate images.
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We expect the sponsor to document description of specific features with

adequate testing outcomes that mitigate risk from software being used on a 

smartphone or an inadequate camera. So we expect documentation of the 

specifications to the use of the app with the camera and the computing 

platform. 

To sponsor should document that impact assessment and justification for their 

determiniation regarding the adverse impact of the other functions in 

accordance with their quality system. 

And finally in this example, the smartphone platform and the camera are not 

evaluated as part of the premarket review. So the testing outcomes of the 

device functions under review’s performance related to using a smartphone

and the camera are evaluated. Next slide. 

The next example is on page 23 of the guidance about an energy delivering 

aesthetic device with an optional app that transfers treatment parameter data 

for cloud-based storage for later review by a physician. In this example, the 

device function under review is an energy delivering aesthetic device. And 

the other functions are the mobile app that integrates the device and transfers

treatment parameter data to a cloud-based storage system, and we know 

there's no real time transmission for this other function and another other 

function is smartphone computing platform again. 

In answering the first question, we determine that the energy delivering 

device function is not impacted by the mobile app that transfers data or the 

smartphone computing platform because the transmission of data cannot occur 

during the energy delivery. Next.

So we answer no the first question. Then next, and the flow chart leads us to 

the document this impact assessment and justify the no impact determination. 

We do not need to include documentation in the premarket submission to 

discuss any increase risk or adverse effect because we determine that there is 

none. And the sponsor documents the impact assessment and the justification 

for the determination regarding no impact of the other functions in accordance 

with their quality system. 
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And finally the mobile app in the smartphone platform are not evaluated as 

part of the premarket review and note that again, no documentation of those 

other functions is necessary for the premarket submission of the device 

function under review. Next. 

The final example we'll discuss today is the pulsed ultrasound and biopsy 

needle guide kit which is on page 24, the last page of the guidance. This is an 

ultrasound pulse echo imaging system with software-based biopsy needle 

tracking functionality that needs to determine the depth or location of the 

tissue interfaces for use with the biopsy needle guide kit for delivery.

In this example, the device function under review is the general purpose

diagnostic ultrasound system and the biopsy needle tracking functionality. 

The other function in this case is the 510(k) exempt biopsy needle guide kit. 

In answering the first question, we determine that the biopsy needle guide kit 

is a convenience tray that combines a number of other ultrasound accessories 

that have already received 510(k) clearance or are Class I 510(k) exempt. 

And 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 function should be compatible with the biopsy 

needle guide kit. So we answer yes to the first question. Next. 

And next one more time. So we move to the second question. And we 

understand that 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. Next. So we answer yes 

to the second question. Next. 

And we determine that we need to include documentation in the premarket

submission demonstrating that the increased risk or adverse effect is 

mitigated. We'd expect that sort of biopsy needle tracking software intended 

to be compatible with various ultrasound needle biopsy kits that performance
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testing should be provided showing that the accuracy and precision meet the 

specifications and requirements of the subject device.

The impact assessment and justification regarding potential adverse impact of 

the other function should be documented in accordance with the quality 

system and the sponsors should document that any further processing of the 

kit in the component does not significantly affect the safety or effectiveness of 

any of the components under quality systems. 

Again, the biopsy needle guide kit itself is not evaluated as part of the 

premarket review process. So the safety and effectiveness demonstration of 

the device function under review related to the compatibility of the biopsy 

needle tracking software with the biopsy needle guide kit is evaluated. Next. 

That concludes what we intended to cover today. In summary FDA recognizes 

that our regulation plays a crucial role in the development of technologies that 

could significantly impact everyday life. We believe that our approach to 

regulating these products should foster innovation while protecting public 

health. The guidance is aimed at clarifying our policy for all multiple function 

products that contain at least one device function. And the final guidance 

incorporates feedback from public comments to clarify and provide examples 

to describe our policy on products with multiple functions. 

We hope this guidance provides clarity for manufacturers, FDA staff and 

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

Act. And this is all part of FDA's long term Digital Health Innovation Action 

Plan. Next.

I’ll point you to the web link for the multiple function device products 

guidance online. And if you have any questions regarding digital health 

policies such as if you'd like help determining if your product would be 

considered a multiple function device, you can reach out to us at 

digitalhealth@fda.hhs.gov. Next. 

If you have any general questions you can always reach out to the Division of 

Industry and Consumer Education or DICE at dice@fda.hhs.gov. The slides
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and transcript and recording of this webinar will be available online in the 

next couple of weeks. And I'll pause now to assemble the questions. 

Coordinator: If you would like to ask a question please press star then one. Unmute your 

phone and record your name clearly when prompted. If you'd like to 

withdraw your question, press star two.

Sonja Fulmer: While we're waiting for the questions to come in, I'll go ahead and introduce 

my colleagues who are also on the line to help answer the questions today. 

I'm joined by Cathy Bahr, who's the Senior Adviser in the Division of Digital 

Health. Linh Lo who's the Regulator Adviser in the Office of Product 

Evaluation and Quality or OPEQ and Aneesh Deoras who is an Electrical 

Engineer and team lead in the Division of Cardiovascular Devices in OPEQ. 

Do we have any questions ready for us?

Coordinator: The first question is from (Alexander Walsh). Your line is now open.

(Alexander Walsh): Hi. So the question I had was the guidance document describes how 

manufacturers should consider the impact of an other function on the safety or 

effectiveness of a device function under review. But it doesn’t seem to 

address the opposite case where the effectiveness of an other function might 

potentially be impacted by a device function under review.

If there's a chance that the effectiveness of an other function such as 510(k)

exempt function could be affected by device function under review, would 

that change the status of the other function to turn it into a device function 

under review?

Sonja Fulmer: I think that that question is ... 

(Alexander Walsh): I can give an example if that's not clear.

Sonja Fulmer: I think I understand. But it's -- if I'm missing the mark please let me know.

(Alexander Walsh): Okay.

Sonja Fulmer: I think the 510(k) exempt function, if the combination of it with the device 

function under review impacts its safety and effectiveness and there's a 
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significant impact then you should consider the modification guidances that 

are linked on the slides and that are available as links from the multiple 

functions guidance as well to determine if there's any change to that function 

that would require a 510(k).

(Alexander Walsh): Okay. But if the -- for the 510(k) exempt function, if there was a 

modification and some like to the 510(k) exempt function, that might not need 

to be addressed by that same flowchart?

Sonja Fulmer: I think it would be outside of the scope of the flowchart. I think you would 

have to consider the limitations of the exemption for that function. And if a 

modification to it changes whether or not it's still within the exemption and if 

it would need its own 510(k). And I think that might be better answered 

through the modifications guidance.

(Alexander Walsh): Right. Okay. Thank you.

Sonja Fulmer: Aneesh, did you want to jump in there?

Aneesh Deoras: No. That makes perfect sense and I think that's the appropriate way to go. 

There's certain changes that are relevant to 510(k) exempt devices and excuse 

me, certain discussions on 510(k) exempt functions in the guidance document. 

Definitely would recommend checking that out particularly on page four.

(Alexander Walsh): Good. Thank you.

Coordinator: The next question is from (Samehedan Mohen). Your line is now open.

(Samehedan Mohen): Hi. So if there is a system and we decide that and the manufacturers 

decides that this could be a multiple function device, that a few functions are 

medical device and a few functions of non-medical device. Is there a way for 

us to what this decision out with FDA? Could we do like a pre-sub or a

513(g) to make sure that our decision is correct and FDA is aligned with it?

Sonja Fulmer: Yes, absolutely. Particularly if you have questions about whether or not any 

of those functions are actually non-device functions or if any of them are 

meeting our new policies we’ve expressed forenforcement discretion. That’s 
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something that you can do as part of the 513(g), and pre-submissions may also 

help you understand how we would expect those other functions to impact the 

device function under review. So I think that's a good place to have that 

discussion with FDA.

(Samehedan Mohen): Thank you very much.

Coordinator: The next question is from (Dean Papadopoulos). Your line is now open.

(Dean Papadopoulos):Yes. Good morning everyone. Question around how I interpret this 

guidance, multiple function device product guidance in conjunction with the 

policy for device software functions and mobile medical applications 

guidance. Is there a succinct way of describing the difference between those 

two documents in terms of how they -- how they should be applied in the 

510(k) submission process?

Sonja Fulmer: Well, I think that guidance, what we've traditionally called the mobile medical 

applications guidance or MMA guidance really helped everybody understand 

what types of functions meets the definition of device, what types of 

functions, if they meet the definition of device that are low risk. And so we 

describe our intent not to enforce compliance with applicable regulatory 

controls, what we call under enforcement discretion.

And then also those that are the focus of our oversight. And so if you have a 

multiple function device product that has, you know, any number of those 

types of functions together in one product, it'd be helpful to use the multiple 

functions guidance to help you understand how some of that other functions, 

the ones that are non-device functions or the ones that are under enforcement 

discretion may impact the safety and (attachments) of the device function 

under review. So the devices that are listed in MMA guidance as being the 

focus of our oversight, you would want to understand how the other functions 

could impact those.

(Dean Papadopoulos):Okay. All right. That's helpful. Thank you.

Coordinator: The next question is from (Jeff Bowen). Your line is now open.
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(Jeff Bowen): Thank you. I had a question that kind of ties to this and a lot of the more 

recent guidances that have to do with expanding devices for telemedicine 

application. So the addition of video conferencing functionality to devices so 

that healthcare professionals can communicate with each other across 

distances to either guide the other to operate the medical device to acquire the 

data and then have screen mirroring functions. So it appears as though a lot of 

those -- that type of device functionality would already be exempt or defined 

as another function as described by this guidance.

But it appeared as though the -- those guidance's for expanding that type of 

capability interpreted to not be the case. And I was just wondering if there 

was some clarification on that that could be provided.

Sonja Fulmer: Can you clarify what you mean by not be the case?

(Jeff Bowen): So, yes, it seemed that instead of referencing this guidance to remind people 

that those types of functions are non-device functions. And that companies 

could implement or utilize video conferencing technology with their systems 

without the need to submit an additional premarket submission. 

It simply stated that they would be under enforcement discretion or that they 

would not object to the addition of these types of functions. So that's what I 

mean because it appears as though that one in public health emergency. And 

that it would be enforced when in fact it shouldn’t because of what's outlined 

in this guidance that you just described.

Sonja Fulmer: So I think that's for the functions that are in our MMA guidance for example 

as non-device functions like some of the video conferencing examples. I 

think those -- those will always be non-device function. And I think that the 

multiple function policy that we've described here in this guidance applies in 

those cases when there is a combination between those functions and the 

device function, whatever it maybe. 

I'll have to take a closer look at the example you're describing and you're 

welcome to reach out more directly to digitalhealth@fda.hss.gov to get more 

clarity on that.
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(Jeff Bowen): Thank you very much.

Coordinator: The next question is from (Alison Komiyama). Your line is now open.

(Alison Komiyama): Hi. Thanks so much for hosting this webinar. For a product that has 

already undergone non-significant risk clinical testing with its multiple other 

functions including a mobile app that controls those other functions. How 

does FDA recommend that we demonstrate that the other functions truly do 

not impact the medical device function namely its effectiveness? Would a 

risk assessment included in the premarket submission be acceptable in this 

case?

Sonja Fulmer: Just to clarify. Did you say that there is a function that's controlling the 

medical device?

(Alison Komiyama): The medical device is not being controlled by mobile app or the other 

function. There's multiple functions going on with this device. But it's -- in 

the clinical study everything was run at the same time. So it's hard to parse 

out just the sole medical device function. If anything, the other functions may 

have a positive impact. But how do we best explain that to FDA?

Sonja Fulmer: I think that if you look through the guidance and consider the questions that 

we recommend to help understand how the impact -- how there maybe an 

impact on the multiple or excuse me, on the device function under review, you 

can follow those questions, understand what we would expect you think about 

and -- and what we would expect to see in the premarket submission on it. If 

there is a positive impact and that's something that you would like to claim, 

you want to have it labeled is important. Then you would want to include the 

information in the premarket submission that we went over in the one table.

(Alison Komiyama): Okay. Thank you.

Aneesh Deoras: Hi. This is Aneesh on the line. I think you also had a question about the 

content of your premarket submission so Section 7 in the guidance document 

discusses that in more detail and beyond the hazard analysis so your risk 

assessment. There are other aspects that can help describe your argument for 

the impact of the other function on the medical device function such as 
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Moderator: IRENE AIHIE

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Page 21

explaining the architecture of your device, your software requirements and the 

testing conducted on your device. So there's some helpful information there.

(Alison Komiyama): Okay. Yes, I guess the biggest thing we're trying to avoid is running a 

whole new 1,000 subject clinical trial.

Aneesh Deoras: Sure.

(Alison Komiyama): And that yes, so the biggest thing, it's hard to parse these things out. But 

so we think we have a strong argument on why those other multiple functions 

aren't making an impact or if anything is a positive impact. It's just hard --

yes, it's just that we want to make sure we're making a stronger case. So thank 

you very much. That's helpful.

Coordinator: I'm showing no further questions at this time.

Irene Aihie: Thank you. This is Irene. We appreciate your participation and thoughtful 

questions. Today's presentation and transcript will be made available on the 

CDRH learn webpage at www.fda.gov/training/cdrhlearn by Friday 

September 18. 

If you have additional questions about today's presentation please use the 

contact information provided at the end of the slide presentation. As always 

we appreciate your feedback following the conclusion of today's live webinar. 

Please complete a short 13-question survey about your FDA CDRH webinar 

experience.

The survey can be found at www.fda.gov/cdrhwebinar immediately and 

following the conclusion of today's live webinar. Again thank you for 

participating and this concludes today's webinar. 

Coordinator: This concludes today's conference. All participants may disconnect at this 

time.
FDA WEBINAR

Moderator: IRENE AIHIE

09-10-20/11:00 a.m. ET

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END