FDA Webinar

Moderator: Irene Aihie

08-01-17/1:00 pm ET

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FDA Webinar: Digital Health Software Precertification (PreCert) Pilot Program

Moderator: Irene Aihie

August 1, 2017

1:00 pm T

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

listen only mode. During the question and answer session of today's call, you 

may press star followed by one to ask a question. Today's conference is being 

recorded. If you have any objections, you may disconnect at this time. And 

now, I'll turn the call over to Irene Aihie. You may begin. 

Irene Aihie: I am Irene Aihie of CDRH's Office of Communications and Education. On 

July 27, the FDA announced additional health innovation action plan and the 

launch of the agency software pre-certification pilot program. The FDA 

recognizes that we need a regulatory framework that accommodates the 

distinctive nature of digital healthy technology, its clinical promise, its unique 

user interface, and the industry's compressed timelines for new product 

introductions.

The Digital Health Innovation Action Plan provides details and timelines for 

our integrated approach to digital healthy technology and the implementation 

of the 21st Century Cures Act. Today, Bakul Patel, Associate Director for 

Digital Health in CDRH will present an overview of both the Digital Health 

Innovation Action Plan and the Software Pre-Certification Pilot program. 
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Following Bakul's presentation, we will open the line for your questions 

related to the information provided through the presentation.

Additionally, there are other center subject matter experts to assist with the 

Q&A portion of our webinar. Now, I give you Bakul.

Bakul Patel: Thank you, Irene, and thank you everybody for joining the webinar. I'm 

really excited to talk about the action plan and the pilot program, but before 

we do that, I want to cover three things today and I'll touch upon that briefly 

before we start. One is how we got here, all the work we have done so far, all 

the policies that we have put in place, and how we are adapting, and how we 

are taking that into consideration as we move forward.

Two is the details of the action plan of what we are going to do to align 

ourselves and meet the requirements of the law that we just got on 21st 

Century Cures. And most importantly, share with you the concept of the precertification idea or the paradigm we are trying to shift towards that will allow 

people with excellence in organization as well as culture of quality to advance 

and have products available to the patients in the U.S. with high quality. So 

how do we sort of do that and try out -- we are announcing the pilot program. 

We announced the pilot program last week to talk through how we can -- or 

learn how we can sort of best design the program with the help of the pilot 

participants.

So let me just take you through the slides here to talk briefly about how we 

got here. Most importantly, you all know the advances of the digitization 

that's happening is really affecting everybody across the spectrum and is really 

moving healthcare from the clinic to the patient. And as we sort of dive into 

how competing power sensors and connectivity, along with software, is really 
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changing how healthcare is being viewed is really important for FDA to take 

and allow these technologies to be available to the marketplace. 

And the next few slides I'm going to share with you, it really talks about how 

we have been approaching these. We at CDRH care about patient centered 

healthcare. We also want to bring trust and innovative technologies to all the 

stakeholders in the healthcare, and finally, we do want to partner and our pilot 

program is an indication of how we want to partner with our customers, and 

using the word customers on purpose, they mean all stakeholders including 

patients, including providers, including caregivers, and developers who can 

get us to a digital future ready state.

When we think about how we are approaching our policies, we look at this 

risk based approach as a fundamental, which really takes us to this 

functionality focus, which means that we really are agnostic about how small 

or how big a product looks, but really focused on what the product does. It 

allows us to give and allows everybody to have independence from the 

technology that's being developed at a very fast pace. It also allows platforms 

to evolve over time and promote innovation in that area where technology is 

moving at a very, very fast pace.

The other part of our thinking has always been we want to be narrowly 

focused, which means we will continue to focus on higher risk technologies, 

but not necessarily focus on all technologies, which will allow us to sort of get 

to promoting patient engagement and protecting patient safety. So this is the 

paradigm we've been thinking since 2013 and we published several guidance, 

which sort of outlines our policy or thinking and looking at how we would 

approach from a digital health perspective and how they have now became 

foundational in what is considered higher risk and what is considered to be 
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lower risk, and taking a very pragmatic approach towards overseeing them 

with a very practical and an integrated approach.

This work was not done just unilaterally within the U.S. but we have also been 

leading efforts on the international front to create a framework with our 

international partners, regulators across the globe to come up with a 

framework for software as a medical device that actually will level set the 

approach that every regulator takes across the globe when such technologies 

are available to the patients.

So we have been working through that and they have also become 

foundational building blocks for how we will approach and how we are 

thinking about it. So taking another step from a different perspective, 21st 

Century Cures codifies some of the policies that we had in the U.S., and is the 

slide I showed you before with the guidance that we put out, and it now 

codifies some of these policies.

When we look at what 21st Century Cures does, it really takes our guidance

on mobile medical apps guidance, medical device data systems and looking at 

how we would approach electronic patient records as we described in the 

FDASIA Health IT report and codifies that. We will providing a lot more 

clarity on that aspect.

But as we do that, we have to look at what's happening in the current situation. 

It is really rapidly evolving in front of us and what we want to share with you 

today is we have taken all these aspects . 

If you take a look at where we are in our situation, we have our current 

regulatory paradigm and we have unique aspects of digital health where we 

have been regulating products on a risk base for the longest time. 
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We have a certain capacity to review products. We also know that the current 

paradigm is best suited for products regulated today. When we match it with 

some of the unique aspects of digital health, especially in the software, you've 

seen the development timelines and the fast pace of innovation and iterations 

that have happened have changed and brought different challenges and 

considerations for us to think about. We also see emerging issues such as 

cybersecurity and interoperability push and pull the need for us to sort of be 

more transparent, at the same time be more secure.

We have also seen that the potential for increase in volume of applications 

have increased, and if you think about how software is being developed, how 

soon software can change over time, it really begs for us to think about how 

can we look at it differently and what paradigm should we think about that 

actually best suits for overseeing software in this space that rapidly evolves 

and changes at the same time. In the case of software, there is a need for 

changes to happen and how can the regulatory paradigm enable that.

When you bring it all together, when you take the work that you've done so 

far, the work that we have done in the international front, you consider the 

current 21st Century Cures and the modifications to the FD&C Act, and then 

take into unique aspects of digital health, it really takes us to the action plan, 

which really tells us how -- talks about three things. We will be defining our 

policies and providing guidance of how 21st Century Cures apply, how does 

the international framework sort of -- can be considered as part of our 

foundation -- and most importantly, we want to look at what does a new 

streamlined pathway really look like as we move forward. 

The last part, I will speak on this a little bit, about building bench strength . 

As we have said many times, we want to be -- FDA needs to be at a place 
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where we can actually have a very strong conversation and a parallel 

conversation when we have submissions in house. At the same time, we want 

to be in line with the technologies that are evolving. So we want to build our 

bench strength with the right technical expertise.

And to that effect, as we launch into the pilot program, which I'm going to 

share the details shortly, we also will be announcing in the next few weeks, 

the launch of the entrepreneurs in residence program. We'll talk about that a

little bit more further but let me go into the details of how are we providing 

policies and what we are providing guidance on next.

There are two big things we are doing. We are taking our existing policies, 

matching it up with the 21st Century Cures Act, and effect of the act on those 

guidance, and will be updating those guidance. But before we do that, we will 

publish an interpretation guidance that we plan on publishing by end of this 

year that will allow everybody to comment on how we are interpreting the 

21st Century Cures, being transparent in that way, and then making changes to 

those finalized policies that we have.

That's happening this year. Early next year, in Q1 of 2018, we will be 

publishing two major guidance. One is on clinical decision support software 

that reflects the intent of the 21st Century Cures Act, as well as our review 

and our oversight on products that comingle, portions that are regulated and 

portions that are not regulated. We call that as multi-functionality but 

thinking about -- taking a look at how we would approach that and seek 

comment for that as well. So we will be publishing two draft guidance in 

2018 and one major guidance in 2017.

We also are looking at the effect of 21st Century Cures and effect on the 

regulations that we have in place and we'll be updating those as well. So you 
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can see there is a lot of activity going to happen between now and Q1 of next 

year. We want to make sure that you all are aware of and that's covered in our 

action plan. 

Let me share to the part where I think most of you guys are eager to listen to, 

where we need to go from here on. I think it's important to take into account 

what we have done so far, what we have in front of us, and take it to a place 

that really makes sense for FDA oversight to be in a place where it's in line 

with how software is being developed, it's in line with global regulations and 

regulators that are aligned to the foundational framework that we have been 

working on, and it's aligned to practices and real world experiences that folks 

use, and experience, and practice day-to-day.

So what does that look like? This bring us to this fundamental shift on how 

we would want to oversee technology and in the past, we have been 

overseeing technology as one product at a time. Somebody brings in 

information, we look at the product and the intended use, and we give them 

clearance or approval, or they can market a product. We are looking to shift 

to a fundamentally different approach where we would base the marketing 

authorization on a company's demonstrated culture of quality and 

organizational excellence.

So moving to a model where a company based streamlined regulatory 

approach for software as a medical device that relies on a demonstrated 

culture of quality and organizational excellence. So folks may be thinking, 

what does that mean? So let me just take you one step higher than that 

sentence and share with you how we are thinking about it. And just to share, 

this is a concept and a starting point to work through in the pilot, but this 

becomes a foundation for how we would approach in the pilot itself. A 

company that is pre-certified or goes through and proves or demonstrates a 
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culture of quality and organizational excellence would avail themselves to a 

pre-cert level. And we don't know the answers how many levels but that's 

something we will figure out.

Once a company is certified then based on the risk of the product that they're 

making or the products that they're making, they could be afforded a straight 

to market pathway or through a short streamlined pre-market review pathway. 

On the postmarket part because software is so connected and is so connected 

to the end users, we would ask those companies that go through this pathway 

to collect or understand how their users actually interact with their products 

and that's something that is available for software as a unique feature that's not 

available elsewhere all the time. So how do you sort of leverage the 

connectivity and how do you sort of leverage the computing power to 

understand how the product really works in the marketplace. 

We hope that would allow people to start at a very low level who are not 

experienced or who are trying to enter into the marketplace and learn more 

about their product, and learn -- collect more evidence as the real world use 

evidence in practice -- and use that as a basis to substantiate higher level 

claims so to speak. So that's the paradigm we're looking at and that's what we 

call a real world data collection. We need to figure out together, as part of our 

pilot, how best we sort of do this.

So the concept is a starting point and you would take this to the next level as 

we start diving more into the pilot program itself and learning from 

everybody. Let me dive a little bit deeper into what we mean by culture of 

quality and organizational excellence. The goal for having an organizational 

excellence or a culture of quality and organization excellence is to have an 

ability to get a software as medical device to market faster. We also want the 

software to iterate based on real world experience.
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We think that in the world of software, iteration is actually better for public 

health where things can be corrected and fixed based on how products are 

performing in the real world. We also want people who participate in this 

program to have an excellent regulatory experience and have great 

predictability. We are hoping that companies will strive for excellence from 

here on. We also are hoping to our objective of promoting high quality and 

effective innovation in this space, and we would want to create a very 

transparent pre-cert program that would actually help everybody understand 

where they stand and what they want to improve on, what they need to 

improve on.

So to start with, you can imagine the CQOE as balanced score card elements, 

as you can see here. We're starting with the five basic tenants, providing safe 

patient experience, delivering highest quality products, being clinically 

responsible, being cyber responsible, and being proactive versus reactive. 

These are the common things that FDA has always been wanting to sort of 

impress upon and (unintelligible) impress upon to our current regulations. So 

it should not be something new that we are expecting but it is rather a more 

holistic way of looking at it from the intent of the regulations than actually the 

regulations itself.

So how are we thinking about this? If folks can demonstrate through the 

different lenses that they have within their organizations and how they are 

actually managing their organizations through key performance indicators or 

other similar measures through their organizational perspective, through their 

customer perspective, are they learning and growing and do they have internal 

processes that can actually provide a holistic aggregate key performance 

indicators to suffice those key scorecard elements. That's what we are looking 
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for. Again, this is a very high level concept and this is something we will 

want to flush out further. 

The fundamental idea here is to take one of those elements and look at it from 

multiple perspective, just like you would do in a business, just like your CEOs 

would do in a business where they would actually look for how the business is 

performing, not just by looking at one portion of their business but all options 

of their businesses and seeing what the outcomes of their processes that they 

have and the infrastructure they have put in place. 

So that's the premise. So I'm sure you guys will have a lot of questions on 

this. I'm sure we'll learn a lot through this process itself, but it's really the 

concept that we want to start from and take it to the next level. I won't read all 

the bullets on this slide, but this is a snapshot of what we want to achieve or 

what we want to desire when we have a program like this. We want to enable 

very modern and efficient regulatory framework. It should be an easy to 

follow process. These are sort of the constrains we are putting on ourselves 

and we are putting on us as a sector and a community to make sure that the 

highest quality products are available.

We want to make sure that it's repeatable and it's scalable for organizations of 

any size. This program should be that it learns and adapts over time and to 

that effect, let me share this other picture with you where we think not only as 

you -- as makers of the software or makers of digital health tools would learn 

about how well your product is performing with real world use data, you want 

to understand also how effective is our program. So we're trying to create our 

own feedback mechanism to learn best and perhaps modify over time what's 

the right metric and what's the right KPI, what's the right scorecard elements, 

and what are the decision points that we need to adapt over time to create a 

system that will not only sustain for today but also sustain for tomorrow.
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And that's really the vision we have here to make sure the regulatory paradigm 

also stays current on an ongoing basis as technology evolves. Last but not 

least, I'm going to talk about the component where we do want to take the 

knowledge and the learning that we have, that we put out through guidance 

documents, and create a toolkit, a development toolkit similar to a software 

development toolkit that's been available for software developers to create a 

regulatory development toolkit that would help not only the new entrants but 

also folks who are trying to create software solutions or digital health 

solutions in a space that may require many perspectives or that may require 

other considerations.

Now, we do have those considerations today in different formats, in different 

guidance, but may not be easily available or easily accessible, or not know 

where to look for. So we are hoping this regulatory development kit is a 

contextual based system that can allow people to ask the right questions, look 

for the right guidance that FDA has put out in the space of software and 

digital health, and guide them through the process so there is clear 

understanding how well they can make a product and be successful in the 

marketplace. 

So to summarize, the concept itself has three big components, FDA pre-cert 

that allow -- that is company based, that will give us the trust in the company's 

making these products and having that trust would allow us to avail a faster, 

streamlined pathway to market, a regulatory development kit that will get the 

companies started off in the best standing to be successful, and lastly, for us at 

FDA, to learn and adapt a regulatory program that actually can stay current 

and where technology and aspects sort of evolve over time. 
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To actually take this concept to the next level, we announced a pilot program 

last week, and this pilot program is an interesting approach and a slight 

departure from what somebody would think about as a pilot program. Give 

me one second. We have some technical difficulties. You're probably not 

seeing my slides. Where I left off previously, I'm just going to back up one 

slide and we left off at the building blocks of the concept itself. But taking us 

to our pilot program, what we want to really do is sort of try to understand the 

details of the program and of the concept that we have laid out, and try to 

build it with folks who are going to be participating. But at the same time, 

you should be not looking at the pilot participation as the only folks who are 

going to be helping us build this. I want to encourage everybody to sort of 

provide their input and their knowledge as we move through.

So let me share how we are scoping the pilot, what we're going to do, and 

what we are expecting people to do from here onwards. The scope of the pilot 

we are choosing to limit it to software as a medical device itself, where we can 

say that manufacturing is developing or planning to develop software as a 

medical device, as defined by the international committee, MDRF, is the 

definition you're going to start looking at.

What does that mean? It means that software has its own medical purpose as 

defined in the FDNC Act is really what we are looking for. It can run -- it 

doesn't really matter where it's located and we've been discussing this concept 

for the longest time. What we don't want to include is things that are 

embedded in controlling medical devices like infusion pump or a cardiac 

pacemaker. Those kind of software is not what we're talking about. We are 

starting with really something really very small that is software as a medical 

device itself.
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Now, there are some criteria and you can look at the guidance document that 

people -- that we have published, but really want to take a look at that scope 

and sort of taking it to -- and seeing we can select those pilot participants from 

that group of those developers. We are also looking at software function that 

is not excluded from medical device definition. So really, you want to make it 

relevant to the community we are looking at. So how are we going to run the 

pilot? As you can see, there are many unanswered questions and there are 

many things that we need to still figure out and we are looking at how we 

would go forward doing this.

The pre-cert pilot is really a mechanism for us to learn and we have a concept, 

which I shared with you. It's at a very high level and how do you take it to 

informing the regulatory program? We are going to take the first few 

candidates or the participants and input from others to try out, test it, and then 

further evaluate and refine as we iterate down this path towards the paradigm 

how you're going to take a trial run of a first few candidates, would apply to 

the next few candidates, and sort of iterate and use those learnings back 

towards building and answering some of those questions that may be open 

right now.

We are also looking at gathering input from others who actually may not be

selected because I totally understand that having a participant pool of nine 

may not be fully reflective, but we are working towards an event in January of 

next year, early next year, to bring this conversation back in a public forum 

that we can discuss all the details and sort of learnings so far. 

So what are the things we want to learn? Here are the things we know and we 

have questions for. How do we sort of do that? What are the pre-certification 

components? How do we leverage industry measures to benchmark these

elements. If people are doing that, we want to learn from that. So we 
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anticipate in the early parts of the iteration we would probably benchmark 

that.

We will also develop and evaluate how to measure the criteria for those 

benchmarks, and from there on, we'll develop the certification correlated to 

that with the risk type of the software they are making. We also want to look 

at those boxes where we have questioned them, what decision criteria we 

could use, and we would develop that. And if there was a review and 

streamlined review needs to happen, what would that look like? What does 

the content look like, what does the method look like, should we still look at 

paper submissions or submissions of that kind, or should we look at some

other artifact.

And then very last -- and more questions to follow is what does that mean to 

collect post-market data -- when and how -- what's expected. I think we need 

to work on all those things and if we want to work with all of you sort of work 

towards that and to answering those questions. And I can share with you that 

this is a lot of work and it cannot be done only by FDA, and I think we need to 

work together to sort of figure out how best we can sort of learn together and 

create a system that works for everybody.

Some of the things, before we launch into the pilot program, I wanted to just 

logistically want to say, we are opening applications now and will continue to 

sort of get applications until we suffice the criteria that we laid out in our 

federal register. And I won't read through all the selection qualities, but really 

what we shared in our federal register is about we would take applications or 

we would consider them, provide a statement of interest and expect to be part 

of this learning process along with FDA and with other stakeholders to sort of 

go-forward with it.
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So here are some of the things that we are thinking about as characteristics of 

folks who would be part of the pilot program. We would want to have large 

and small organizations. So we understand how a large organization works 

and a small organization works. We want to get perspectives from our 

traditional medical device industry as well as perspectives from folks who are 

not traditionally in the medical device industry, but are thinking about 

entering this market.

We also want to learn from best in class and folks who are trying or looking at 

opening low to high risk software as a medical device. Here's some more 

details about what we expect the participants and CDRH to work 

collaboratively with. We'll work together. I think the point of this slide is to 

just share that we are going to work together on how we can determine the 

answers to this question and we will evolve as we iterate to the process itself. 

But really what we want to do is learn from what's happening best, translate to 

how can we actually meet our goals and the goals of the program and 

oversight, and how can we sort of figure out a way that would actually be 

helpful for everybody.

To summarize the pilot process itself, applications are starting now. We will 

select no more than nine participants and develop program elements 

developed by the participants. If folks are interested, they should email the 

statement of interest with subject line, "Pre-Cert Pilot Statement of Interest" to 

fdaprecertpilot@fda.hhs.gov. I want to also emphasize one thing that even 

though the participants are only nine, we are also looking for input, which 

means that folks may have their own ideas and thoughts based on the concept 

and we can take those concepts and input it into our program itself, how do we 

sort of provide that -- provide a channel for that input is also important.
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So to that effect, the federal register docket that we have created for the 

federal register notice that we published last week, would be a great avenue 

for folks to submit their input to the program itself and components of the 

program as we move forward. You should look forward for continuous 

communications on this and we'll be updating our website on how we are 

progressing, and we'll be as transparent as we can, making sure that the 

participants' confidential information is protected.

To end with, I just want to share the pilot is an important first step for us to 

explore the elements of the program. It is part of our continuous effort to be 

pragmatic and balance the benefits and risk of the digital health products, but 

most importantly, we want to collaborate and be a partner in this learning that 

we will have going forward to actually build a program that will be best suited 

for this fast and evolving technology space that actually holds the promise for 

bettering healthcare paradigm.

With that, I will just turn it back over to Irene but if you have questions, this is 

probably a time to ask questions. Irene, back to you.

Irene Aihie: Thank you, Bakul. Operator, we'll now take questions from participants.

Coordinator: Thank you. We will now begin the question and answer session. If you 

would like to ask a question, please press star followed by one. You will be 

prompted to record your name. To withdraw your question, you may press 

star followed by two. Again, press star followed by one to ask a question and 

one moment please for our first question.

Our first question comes from (Timothy). Your line is open. You may ask 

your question.
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(Timothy): I just wanted to ask about how much of a burden could we expect in terms of 

site visits in the pilot and also, how often we would be providing any metrics 

or aggregated information just so that teams could try to understand what 

they'd be signing up for?

Bakul Patel: Thank you for that question. I think we are looking to be as open and sharing 

the information as possible, but we expect, for example, if you are one of the 

first few candidates or first few participants, we would probably have multiple 

site visits and not to revisit all things, but more about as we learn, we may 

have missed something in the first go round, but actually learn incrementally 

what we may have missed in the first thing.

So I expect a few for the first group, but it should be less of a burden for a site 

visit and it may not necessarily have to be a site visit, and things could be 

answered remotely as well. So that's one way of looking at it. And we would 

be open to working with participants to see what works best. The intention is 

not to disrupt the organizational operations, more about building a program 

that reflects what you guys are doing.

Coordinator: Our next question comes from Penny Levin. Your line is open. Go ahead 

with your question. 

Penny Levin: That was my question. Thank you.

Coordinator: We'll go on with our next question. It comes from Diane Johnson. Your line 

is open. Go ahead with your question and please state your company name.

Diane Johnson: Diane Johnson from Johnson and Johnson. Bakul, I was hoping you could 

provide some insight on kind of the difference between what these site visits 
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would be like versus an inspection and is there any possibility that 

involvement in the pilot could lead to some sort of compliance action?

Bakul Patel: Thank you for the question, Diane, but let me just share with you, this pilot 

program is purely on products that are being planned on or being designed on 

or worked on right now, but more reflective over the company itself. I think if 

there are any issues, we will probably discuss with you ahead of time, but the 

whole idea is we want to pick companies who know that are really good at 

doing the software. So businesses who are excellent at making software and 

managing software, validating software, and designing them is really what we 

want to learn from.

So although there may be some issues that come out, but I think it may be 

beyond the pilot, but the pilot is more about learning rather than compliance. 

Coordinator: Our next question comes from (Rahil Ata). You may ask your question and 

please state your company name.

(Rahil Ata): Hi, (Rahil) from (Vigo) Health. Thanks so much for the call, Bakul. Wanted 

to get some clarification on what information needs to be input on the 

statement of interest. 

Bakul Patel: Yes, absolutely. So as we talked earlier, I think I can just share with you --

I'm back to the slide if you can see it. The statement of interest ideally would 

sort of show some history on how best used in managing, developing, and 

doing good software development as well as validating, as well as managing 

customers. So that would be one of the things. If you're using any kind of 

KPIs or other measures, would you be willing to share with us, or in the spirit 

of learning, and how do you think about from real world post-market data 

collection.
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And those are the kind of things we would be sort of looking for. And really, 

we didn't provide a format and that was on purpose because we anticipated 

folks may actually have different ways of doing the same thing, but we 

wanted to really learn what's best. We would want to get an impression from 

your statement of interest that you are excellent and we -- and that's one of the 

key factors is the size of the company that you are, that you're representing. 

We're looking for both small and large but also we want to learn from the best 

so if you impress in your statement of interest how good you are and how 

some artifacts that help us get to that understanding or demonstrating that 

would be very helpful. 

(Rahil Ata): And will there be any indication on -- or the risk of the device -- should that 

also be included?

Bakul Patel: Of course. Go back to our criteria. I think if you think this is a kind of risk 

profile you're working with or the software you're developing, we don't expect 

you to get it perfect but I think it will just give us an idea of the profile your 

company is sort of meeting. So it will be very helpful. This is a selection --

think about this as a criteria that we are using to sort of select participants and 

we want to make sure that we have diversity in the different accesses. 

Coordinator: Thank you. Our next question comes from (Jaren). You may ask your 

question and please state your company name.

(Jaren): Hey, Bakul. It's (Jaren), Qualcomm. You mentioned really briefly the 

entrepreneurs in residence. Is that going to be a part of pre-cert or is that 

separate? Or are they going to be somehow aligned and what exactly will the 

entrepreneurs in residence be? Can you give a little more detail about it? 

Thanks.
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Bakul Patel: Absolutely, thank you. The entrepreneurs in residence program is really using 

-- bringing in experts from the industry or people who are experienced in this 

industry to work side by side with FDA staff as we are learning through this. 

So sort of help us guide and build this program together. It's neither separate, 

neither part of this program, but it is one of the infrastructure that we think is 

necessary for us to be successful and having a program that sort of reflects and 

guides us through the process.

Coordinator: Thank you. Our next question comes from Tim Klein. Your line is open. 

You may ask your question. Please state your company name.

Tim Klein: Tim Klein, Johnson and Johnson. Does the agency ever think about in the 

long-term having this pre-cert program be something that would be a public 

database such that other companies would know, oh these ten companies, 

these 30 companies are now per-certified, akin to what the agency does with 

establishment registrations or other sort of more regulatory requirements. Are 

you able to speak about the agency's future vision here at all?

Bakul Patel: Yes, I think this is a good start. We will take all those best practices and 

being transparent as we move forward. But really what we want to make sure 

that we are transparent in the fact and it actually helps the goal of people 

striving for excellence, and how do we sort of go forward, keeping in mind 

protecting the company confidential information as well.

So yes, I think that's a great suggestion and I would encourage everybody to 

continue to suggest those things because as you know, we have to balance the 

company confidential information with the transparency that we want to make 

sure that exists. Now, we may or may not use existing tools but I think those 

mechanisms of being transparent will definitely be considered as we go along. 
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And that's something that we will learn what parts we need to be more open 

on and what parts we can't be more open on.

Coordinator: Thank you. Our next question comes from (Arja). You may ask your 

question and please state your company name.

(Arja): Hi, this is (Arja). I'm from (End Point). I had basically two short questions. 

One is are you also going to look at companies outside the U.S. for the 

program? And in addition, when you say prior experience in software 

development, is experience outside healthcare also accounted?

Bakul Patel: Yes, definitely outside healthcare, that's what I mean by we would look for 

people who are traditional medical device manufacturers or IBD 

manufacturers in addition to, we want to make sure that we also get people 

who are traditionally not necessarily in med tech but maybe outside of the 

med tech sector. In terms of the country location, we will look at applicants 

who are planning on this commercial distributing the products in the U.S. but 

again, I'll go back to my first principle is we want to learn and we want to 

make sure that we do have -- we do use the diversity of the participants as 

wisely as possible, balancing our resource needs and other things that is 

reflected in those nine participants.

But not to say that people outside of those nine participants can also learn on 

their own and perhaps even provide that input to us in other ways. 

Coordinator: Thank you. Our next question comes from (Robert Eso). You may ask your 

question. Please state your company name.

(Robert Eso): My question has been answered. Thank you.
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Coordinator: Thank you. Our next question then comes from (Ted). You may ask your 

question and please state your company name. 

Ted Smith: Hi, Bakul. Ted Smith with (Rebone) Systems. Just a quick question on 

whether you'll be looking to any related industry standard certifications as part 

of this process? For example, (Rebone) Systems, we need to comply with 

high trust certification. Are any of these external certification standards that 

you think would be applicable or related to what you're trying to do?

Bakul Patel: We will be looking at -- standards are one way to deonstrate how do you 

measure and understand excellence. One of the fundamental shifts we are 

trying to make is we are trying to allow folks to demonstrate in their own way 

what their excellent standard measures are. So how do we -- I think that's the 

balance we need to learn through and make sure that we get there. 

Now, for certain things like cybersecurity, certain best practices have become 

the norm and have been standardized and been used by everybody, and those 

are perfect ones to use standards. In other cases, some of those measures may 

differ from project to project, from product to product, or company to 

company, and we want to make sure those flexibilities are there, still focusing 

back on -- in the slide that I shared earlier in the concept -- about those key 

elements of safe patient experience, high quality, clinically responsible, et 

cetera.

Coordinator: Thank you. Our next question comes from Howard Luck. You may ask your 

question and please state your company name.

Howard Luck: Hi, this is Howard from Tide Pole. Thank you so much for this great webinar 

and this program. I'm really excited about it. I have three quick questions. 

The first is how are you thinking about site visits for teams that are largely 
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distributed and don't have facilities in the traditional sense. Is it important to 

meet the team or is it really more important to understand how the team builds 

its software?

My second question is about the time commitment for participants in the pilot 

program, especially for a small company. I'm curious how much time you 

would expect us to be a part of this. And then the third is, are there any 

thoughts on organizations -- encouraging organizations to publish how they do 

things, whether it's source code, or software quality system processes as a way 

of encouraging participants to share their best practices with the rest of the 

industry?

Bakul Patel: So great questions and suggestions and I'll try to remember your -- going from 

the top question. I think you're spot on and I think it reflects back to the very 

first question Tim had is what does a site visit mean and what does that look 

like. So I think it's important to sort of keep in mind that a site visit may not 

necessarily be a physical site visit. It could be remote. It doesn't have to be 

and I'd go back to the premise that we want to understand how folks measure, 

manage, and maintain for themselves those key scorecard elements that we 

pointed out earlier. That's one question. 

I hope I'm remembering the second question. Can you remind me what was 

the second one? I forgot already.

Howard Luck: What do you expect the time commitment to be for participants in the pilot 

program?

Bakul Patel: I don't have a great answer for you in terms of exact number, Howard, but I 

think one of the key commitments we're looking for is would you be willing 

to work with us to sort of develop this. And for a small company, it may not 
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be a lot because there may be not much to think about. Or you may already 

have those things and then maybe in place. And in other cases, it might be 

much longer. So I really don't know and I think that's one of the discovery 

and unknowns that we'll have to sort of figure out as we move forward.

We don't expect this pilot to be multiyear projects. We want to make sure that 

we learn quickly. We report back in early 2018 and then iterate from there. 

So that's how we are thinking about it.

Howard Luck: Do you expect companies to publish their software or their processes as part 

of participating?

Bakul Patel: Yes, the level of transparency will differ for every company and how we sort 

of move forward in the type of transparency will also differentiate. I think 

somebody previously asked would we be sharing the CQOE score if that's the 

way we end up going to give people an understanding of what that means, or 

it's a mark, or whatever that level we end up doing. We would want to make 

it as transparent as possible.

Now, whether we -- FDA does it or somebody else does it, still to be 

determined. But I think this is where we are heading and I think the need 

you're pointing out is if there is a way to sort of do this better and in a more 

efficient way, we'll be looking for those methods. 

Coordinator: Your next question comes from (unintelligible). You may ask your question 

and please state your company name.

Jeff Carlyle: Hi, it's Jeff Carlyle from (Numo) Systems. Thank you for this webinar. I 

think the thinking you put into it is really outstanding. So thank you. You 

mentioned specifically that this is aimed at software as a medical device and 
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not at embedded controller stuff, yet it's patient centric. So in almost every 

application that's patient centric, I see a combination of embedded control and 

workstations, and networks, and cloud computing.

So could you give some examples as to what projects would be eligible and 

perhaps which projects would not?

Bakul Patel: Absolutely. I can give you a couple examples. I gave a couple examples of 

some projects that would not be, like an infusion pump embedded software, or 

pacer embedded software, or some other products that we traditionally 

regulate as embedded controller software would not be included. But 

anything that does take patient information and does advanced analytics and 

provide a diagnosis or a cure, or a recommendation per the definition of 

software as a medical device and the guidance that we put out, and meets that 

definition of a medical device is something that we would want to consider.

So something that takes an EKG waveform and now detects a cardiac 

condition that definitely diagnoses it, or it takes something else and diagnoses 

a disease or a condition would be something that we would be interested in

looking at.

Now, one thing to keep in mind is there may be products that use a competing 

platform's peripherals and collect that data, and then does analysis. We would 

consider those products that just uses generic peripherals or generic sensors, 

input devices or output devices, to make a medical purpose intention, we 

would be considering them as part of the pilot as well.

Jeff Carlyle: Well, the confusing part is that an IV pump in the future will be exactly the 

opposite of what you said. It will be an embedded controller. It will be a 

workstation. It will be a network. It will be a cloud computing amalgam 
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because the pump isn't -- you already mentioned patient centricity and if the 

patient is at the center, then the pump does not become the center of the 

universe. It's no longer standing alone. It's part of a patient centric system. So 

it gets a little confusing as to what...

Bakul Patel: So just to give you perspective and not to disagree with you, but in fact, I 

totally agree with you where you're going with this. But in order for us to 

learn from the participants and we have to crawl before we walk, and this is 

exactly what we're doing is we're starting with a very small scope, with a very 

small, narrow sort of perspective and hopefully those things will be 

transferrable to other areas as it evolves. So that's really what we are looking 

at and it's not because this program will be exclusive but it's more about can 

we start here and can we learn in this -- the fastest moving area that we know 

of today and apply it eventually down the road for other software.

Coordinator: Thank you. Your next question comes from (Natan). You may ask your 

question and please state your company name.

(Natan): Hi, (Natan) coming from (Sports D). My first question is you mentioned that 

we look to correct real word, post market performance data and I just want to 

know if you could explain a little bit more about what kind of data you look to 

collect. And second short question is you mentioned you're looking for 

companies with existing track records and I was wondering whether that 

means that you do already have to have some sort of (unintelligible) clearance 

in place, or whether you're also looking for companies that are free 

(unintelligible) (510-K).

Bakul Patel: I'll take the first one is about the real world data collection and performance 

data collection. That's a concept that we've been talking about a lot where we 

said in the world of software, you are exposed to the user in a very intimate 
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way, that you can learn every interaction, how well the software works, and 

how well the software's output is used by the user. So we are encouraging 

people to collect that information, while the software is in use and that's what 

we mean by that.

And you can imagine all kinds of user behavior, including clinical data or 

clinical evidence that can be generated or created based on that interaction. 

So that's what we are envisioning. And the second question -- can you repeat 

your second question?

(Natan): Yes, sure. Second question is about you mentioned you're looking for 

companies with existing track records. Does that mean you're looking for 

companies that have pushed a bunch of products out into the market already 

or are you open working with companies that are, let's say, younger in terms 

of the product life cycle?

Bakul Patel: We are open to companies at all stages but really, going back to is if we can 

learn -- and this is why we are talking about people may not be necessarily in 

med tech, but they maybe in an adjacent sort of market that have a good track 

record in other products, that may not necessarily be medical devices. But 

that learning would be very beneficial for us to sort of take it.

So we are not limiting people that have previous experience or not. It's more 

about making sure that we are looking at people who know exactly how to 

develop software, how to maintain it, and actually manage to those five 

elements that I mentioned before.

Coordinator: Thank you. Our next question comes from Larry Ruben. Your line is open. 

Please state your company name.
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Larry Ruben: Hello, my name is Larry Ruben. My company is called (B-Care Link) and my 

question, and it is connected to the last question that was just asked, and it is, 

if my company is in the middle of doing clinical trials, is that something that 

can also be used as part of the existing track record, or as a key performance 

indicator? 

Bakul Patel: So I'm not fully understanding your question but I'll try to answer it. You 

asked the question whether your company is currently in a clinical trial.

Larry Ruben: Of its software product, yes.

Bakul Patel: If you're looking at a product -- so this may meet the criteria whether you're 

planning to develop or developing. So I think you may meet the criteria of 

that first prong of what kind of companies we're looking at.

Larry Ruben: That answers my question. Thank you.

Coordinator: Thank you. Our next question comes from Jeffrey Kendall. You may ask 

your question and please state your company name. 

Jeffrey Kendall: Jeffrey Kendall with Koni here. The question is would the FDA consider pilot 

participants that are collaborating together, such as a software development 

company and a traditional med tech product company as a joint participant in 

the pilot program? Or would those need to be individual representatives?

Bakul Patel: The way I think about this, it's interesting you guys are asking all these tough 

questions, but the way I think about this is we are looking for a developer of 

software. So if it's made of two or more entities then fine. It could be part of 

a larger organization. That's fine too. But if you've got to sort of trust in a 

business unit or a group that's developing software so we can trust that the 
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product that they're making is of high quality so they can avail straight to 

market or through a streamlined process then really what we are looking at are 

that aspect level.

So the results of having two or more parties be part of a development 

organization may or may not include complexities but that may be a good 

learning to have as well.

Coordinator: Thank you. Our next question comes from Kelly Collins. You may ask your 

question and please state your company name.

Kelly Collins: Hi, I'm Kelly Collins from In Touch Health, and I want to try to get some 

clarification in terms of how one determines if we qualify to be a possible 

volunteer for the program, in that going back to the Cures Act with the 

amended definition of software as a medical device, if those types of 

companies or products are no longer regulated by the FDA, will they fall 

under oversight of the digital health unit?

Bakul Patel: So this pilot program is all about what falls within the definition of a medical 

device and we would continue to sort of focus on that. Things outside of our 

regulatory jurisdiction is really not in the purview of FDA and we would not 

be looking for that space.

Coordinator: Thank you. Our next question comes from (Allison). Your line is open and 

please state your company name. 

(Allison Komiama): Hi, this is (Allison Komiama) from Acknowledge Regulatory 

(unintelligible) really interested in the regulatory pathway of software and 

medical devices, but they -- essentially, they -- some of them are marketing as 
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general wellness currently and their goal is to change their indications so that 

they will be regulated by FDA.

We currently have some pre-submissions that we like to send but since the 

news last week of this pre-serve pilot program, we'd love to see if we are the 

right fit for this. Can we send in the pre-submission as our pre-cert pilot 

certification request? Or if not and if we don't get selected for it, can we still 

submit that pre-sub to you guys, to your team? 

Bakul Patel: So thank you for that question. That was one of the questions I had received 

earlier. I think folks, I would encourage everybody to apply and I think it will 

make our jobs difficult in selecting those nine candidates but I would not shy 

away from applying. So that's one. Number two, if your companies are 

already on a pathway to get a (510-K) and want to be in market, you should 

also look at this pilot as a learning opportunity for us. So it is going to be an 

iterative process where we are going to learn. So as a result of that, I think 

you will be exposed to some of the uncertainties and if you're looking to be 

certain, to be in the market now, I would encourage you to sort of engage 

FDA in the traditional way.

But this is truly about a collaboration that we are looking for, for people who 

can help build it, and be invested for the longer run. 

(Allison Komiama): Would the traditional way be a de novo?

Bakul Patel: I think you would have to contact either -- you can contact (unintelligible) 

software product and additional health product. I would recommend you 

write to Digital Health, email box (digitalhealth@fda.hhs.gov) and we can get 

you the right pathway if you're regulated or not, and we can get you in touch 

with the division to sort of have those discussions.
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Coordinator: Thank you. Our next question comes from Martin McCarthy. You may ask 

your question and please state your company name.

Martin McCarthy: Hi, I'm with what was formerly known as Medical Device Daily and is now 

known as BioWorld Med Tech. Thanks for taking my question. The previous 

questioner raised an issue that I'd like to get a little bit more information on. 

One assumes that this pilot program will be principally or entirely for Class 2 

devices as Class 1 devices are unregulated and I don't imagine that a pilot 

program is really appropriate for a PMA type application, not that I am aware 

of. Any strictly software devices that have gone through the PMA channel 

anyway.

But when I look through the Federal Register and I see successful de novo 

applications, and when I see something in the way of a product code, I never 

see product codes or de novos for software. And so I'm wondering if you 

could give everybody a brief summary of the circumstances in which a de 

novo application might be appropriate for a Class 2 device. And I don't know 

if you know how many pro codes there are for strictly software devices, but I 

haven't seen any and I'm curious as to whether all software as a medical 

device items are lumped together under the code of federal regulations. I just 

haven't seen any indication there's a diversity of pro codes or entries into 21 

CFR.

Bakul Patel: So I think you're way ahead of us in terms of product codes and regulations. 

Even classifications for that matter, what we are starting off with is taking the 

framework that we put together and work together with the international 

partners, and using this pilot program to really taking a big step back and then 

determining what that pathways would look like. And that will result into a 

different, maybe perhaps the same way of pro codes or maybe a different way 
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of categorizing these products with risk levels and the assurance levels we 

need to sort of put them into those buckets.

So to be defined is the short answer but I think that's one of the outcomes we 

want to learn as well from this pilot is what is the right mechanism for us to 

categorize this in the U.S. law.

Coordinator: The next question comes from Bill Evans. You may ask your question. 

Please state your company name.

Bill Evans: Hi, this is Bill Evans from Rock Health. Just curious to know, we work with a 

number of companies in the space that are contemplating or already fall under 

they believe the software life cycle to find an IEC 62304 (unintelligible) for 

quality management systems, ISOs as well. To what extent will this pilot 

program explore explicitly adapting or extending these standards? 

Alternatively, I guess, is it the vision here that this pilot only involves 

companies that are believe to fall outside of those standards under current 

FDA regs?

Bakul Patel: I think we're looking for both and we're looking at how best we can -- rather 

than people conforming to a standard, we are looking at what people normally 

do, to do best software, and then what are those practices. In fact we are --

you can imagine this as learning from what people do best to create a standard 

or create a paradigm that actually recognizes what is best. So I know there are 

standards that have been created to what we have -- what we know so far is 

best and can we validate that? Can we allow people to demonstrate that in a 

way that we all can get on the same page from the same intent and goals 

perspective for the elements I described.
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So I don't know if I answered your question but yes, the answer is if the 

standards are available, we'll take them but if people are following standards, 

but are not able to demonstrate in a very cohesive way, we would want to 

understand that. I guess the bottom line is you want to understand the natural 

state of how best offer is developed.

Coordinator: Thank you. Our next question comes from (Barca). You may ask your 

question and please state your company name.

(Barca): Hi, my name is (Barca) from (Sentionix). I'm wondering about -- hello?

Bakul Patel: Yes, we can hear you.

(Barca): Oh, sorry, okay. I'm wondering what about companies that don’t have a 

product yet but are in the development stage. Is that something because they 

won't be able to collect metrics, right, I mean if their product is not yet 

approved. So is that something that would still be qualified under this 

program? 

Bakul Patel: So we are looking for an entire life cycle management experience what people 

do. So it may not necessarily be you have -- the company may not necessarily 

have experience putting a medical device out to the marketplace, but if they 

have experience doing the same thing in other sectors but now, they're trying 

to apply those best practices in this sector, we would want to learn from that 

as well.

So that's really what it is.
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(Barca): So a follow-up on that, if the company is commercial in a Europe market or 

something, that would be acceptable in terms of collecting data or 

understanding that?

Bakul Patel: Yes, we would not shy away from people who have done good practices in 

other areas. 

Coordinator: Thank you. And our next question comes from Jonathan. You may ask your 

question and please state your company name.

Jonathan Helfgott: Hi, Jonathan Helfgott from Stage 2 Innovations. Thanks again for leading 

such a wonderful collaborative opportunity. My question is does acceptance 

and participation in the pilot program automatically enroll a company into the 

actual software pre-certification program, thus allowing the company to 

receive the potential benefits of the program, such as decreased submission 

content and/or faster review of marketing submissions?

Bakul Patel: Like I've been repeating, Jonathan, I think this is going to be a learning 

process for us rather than sort of definitively saying, once you are in the 

program, you automatically get an approval or a clearance. That's really not 

where we're heading but I think if we partner -- we have the right diversity in 

the nine participants, we would love to sort of work together to a place where 

we would want to understand what a streamlined submission would look like, 

what it would mean pre-market, post-market data collection would look like.

And as a result of that, yes, there may be a pathway that we could say it does 

need clearance to go to market or not. So I think that's to be determined but 

what I want to leave with is really trying to make this as a learning and 

iterative process that we can all work together towards.
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Jonathan Helfgott: Got it, thanks Bakul.

Coordinator: Thank you. At this time, I'll turn the call back over to Irene Aihie.

Irene Aihie: Thank you. This is Irene Aihie. 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 

Wednesday, August 9. 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 the 

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 following the conclusion of the live webinar. Again, thank you 

for participating. This concludes today's webinar.

Coordinator: And this does conclude today's conference. We thank you for your 

participation. At this time, you may disconnect your lines. 

END