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NWX-FDA OC

Coordinator: Irene Aihie

July 14, 2016

2:00 pm ET

Operator: Welcome and thank you for standing by. All participants will be on listen only 

mode until the question and answer portions of today's conference. If you 

wish to ask a question on the phone line, you may do so by pressing star 

followed by the number one. This conference is also being recorded. If you 

have any objections, you may disconnect at this time. I will now turn the 

conference over to Owen Faris. Thank you and please begin.

Owen Faris: Good afternoon and welcome to today's FDA webinar. I'm Owen Faris, 

Director of the Clinical Trials Program within CDRH's Office of Device 

Evaluation. I'm very excited today to be able to provide some updates on two 

important activities within our program. First we will discuss early feasibility 

study, investigational device exemptions or IDEs. And second, we will 

discuss the draft guidance FDA categorization of IDE devices who assist the 

Centers for Medicare and Medicaid Services with coverage decisions, a 

guidance which is currently available for public comment.

After each presentation, you'll be given the opportunity to ask questions and 

I'd like to encourage you to do so. We're hoping for a lively and informative 

discussion today. Carla Wiese, a policy analyst in the clinical trials program 
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will be primary presenter today. We're also pleased to have Rosemarie Hakim 

from the Centers for Medicare and Medicaid Services to assist with questions.

Also with us is Irene Aihie from the Office of Communication and Education 

who will help facilitate today's discussion. Now I'd like to turn the 

presentation over to Carla.

Carla Wiese: Thank you Owen. Again this is Carla Wiese. I'm the acting policy analyst for 

the early feasibility program. And for the first topic today, I would like to talk 

about early feasibility study investigational device exemptions which are a 

valuable regulatory tool for medical device development. I'd like to cover the 

following in this presentation: what an early feasibility study is and how it can 

benefit sponsors, what some key elements of the early feasibility guidance 

document are including what does doing the right testing at the right time 

mean, what a successful pathway to an early feasibility IDE approval looks 

like. I would like to go over some common questions we have received about 

the program as well as some tips. And I'd like to provide you with some 

helpful links.

First I'd like to talk about what an early feasibility study IDE is. An IDE is an 

investigational device exemption. An IDE submission allows an 

investigational device to be used in a clinical study in order to collect safety 

and effectiveness data. An EFS IDE is a standard IDE except for there are 

significant unknowns about how the device will perform. This may be because 

the device is early in development or because it has a new intended use.

Therefore, a small number of subjects are included in these clinical 

investigations, an intent of which is to develop an initial evaluation of safety 

and effectiveness or to establish a proof of concept.

Of note, EFS is an informal designation. And by this I mean it's not necessary 

to submit a request for a designation or apply in any way. Although it is 
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helpful if you note in your submission and cover letter that you are proposing 

an early feasibility study as a means to inform the review team of the type of 

submission they will be reviewing.

Next, I would like to discuss how conducting an early feasibility study in the 

United States can benefit sponsors. First, it can (unintelligible) a more 

efficiently pathway to U.S. commercialization and this can happen in a few 

different ways. First, FDA feedback early in product development may help a 

sponsor improve their development strategy and reduce the chances that 

unnecessary testing is completed. It can also increase the predictability of data 

requirements for a future study or commercialization needs. Also data 

collected in the U.S. population may be easier to leverage to support later 

studies.

Some additional benefits include the following. There's an assurance of 

patient protection under the IDE regulations. You may have better access to 

technical experts and key opinion leaders in the United States. You may have 

better access to technical experts and key opinion leaders in the United States.

There's a logistical advantage in proximity to U.S. innovation centers. And 

this program allows for device iteration including during the early feasibility 

study which may result in higher quality products.

Now there's a lot of information on this slide and I won't go through it all in 

detail but I've included it for your reference. The table points out the 

differences between early feasibility studies and other common types of 

studies. I'll just go over the text in red in the left most column that is relevant 

to early feasibility studies.

So early feasibility studies again contain a small number of patients. They are 

fundamental questions about device performance and safety. The device 
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design may change. There may be limited non-clinical data available and the 

purpose of this study can be for multiple reasons including to demonstrate a 

proof of concept, determine what design or procedure changes could optimize 

the therapy and many more. Of note, not all of these phases are required for 

market approval and what I mean is there may be situations when a device is 

evaluated in an early feasibility study and then a pivotal study without the 

need to conduct a traditional feasibility study.

Next I would like to talk about some key elements of the early feasibility 

guidance document. A link to this guidance is provided at the end of this 

presentation for your reference. The first key element is doing the right testing 

at the right time. FDA understands that comprehensive testing during early 

phases of device development may add cost without significant return and 

some testing may be deferred. However, EFS is not to take the place of 

informative non-clinical testing. A second key element is that unknowns and 

risks can be addressed in several ways including using clinical mitigations to 

provide patients with extra protection, the use of more frequent and detailed 

reporting and the guidance to give specific informed consent 

recommendations that are relevant to early feasibility studies.

Another key element is that the guidance allows for timely device and clinical 

protocol changes. More changes can now be made during the study through a 

five day notification rather than FDA approval and there's a contingent 

approval option. This is the approval of anticipated or proposed device 

changes that can be obtained contingent on the completion of an agreed upon 

test plan and acceptance criteria. And lastly, the guidance contains 

recommendations on pre-submission content including an example risk

assessment method is provided.
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Next I would like to talk in more detail about one of the key elements of the 

guidance document which is doing the right testing at the right time. I believe 

there has been some confusion about how and why less non-clinical testing 

may be needed to support an early feasibility study. For the next few slides, I 

would like to discuss this in some detail which will hopefully provide some 

clarity.

FDA recognizes the value of alternative non-clinical test methods in 

leveraging data. For example, different test methods may be more relevant for 

small batches. An example of this is the single lot ethylene oxide sterilization 

versus completing a full ethylene oxide sterility validation. Also, some test 

data could be leveraged. For example, some biocompatibility and points could 

be leveraged from an animal study if one is conducted. And some test data 

could be leveraged from a previous version of the device.

FDA also recognizes that some non-clinical testing could be deferred. The 

most important concept to keep in mind here is the risk presented to the 

patient after clinical mitigations are considered versus the potential benefit.

Some relevant questions that could be asked include the following. That the 

probability of failure or patient harm understood and can this be mitigated?

For example, perhaps there is a low risk of irritation to a material and should 

if irritation develops this will be evident by evaluating the patient. A possible 

mitigation could be incorporating timely clinical assessments into the clinical 

protocol or use of an appropriate intervention.

Another relevant question may be can a potential failure or harm be detected 

and mitigated? Let's say that there is some risk that the patient may experience 

pain in a given procedure and an animal study will not sufficiently inform us 

about this. An option could be added to the clinical protocol to titrate the 

therapy while evaluating signs of discomfort or reverting to standard of care.
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Another relevant question that could be asked is can the clinical study be 

controlled to further protect patients? For example, it may be possible to first 

evaluate a device in a hospital setting for the early feasibility study instead of 

the home where it may eventually be used, which could change the 

electromagnetic compatibility testing need.

And another question that could be asked is, is the clinical situation emergent 

and/or are there no alternatives available? For example, if the patient's 

condition is critical and they are not expected to survive very long it may 

make sense to defer long term durability testing due to the criticality of the 

short term benefit.

And lastly, will the non-clinical test data provide valuable information on how 

the device will perform in this proposed clinical study? For example, if test 

data will not inform the clinical study today but will characterize the device 

and will be important for developing specifications prior to a marketing 

approval, data could be gathered in parallel with the clinical study and 

submission of this data to FDA could be deferred. Of note, if the clinical 

situation is non-emergent and there are therapeutic alternatives, the amount of 

non-clinical testing may need to be comparable to other available therapies.

When assessing the appropriate non-clinical testing needed to support an early 

feasibility study, understanding and explaining the utility of the non-clinical 

test is important. It is - if it is animal study, which device performance data 

will inform the human clinical study. Is the test conservative or not? Is the test 

validated? Does the test have historical value? And will the test be used for 

quality control in the future? In summary, what will the data tell us? Are there 

options to protect patients when non-clinical testing has limited utility?
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Next I would like to talk a little bit about what a successful pathway to an EFS 

IDE approval looks like. Our first recommendation is that the sponsor is we 

prepared. And by this I mean the sponsor knows what information they want 

to learn from the early feasibility study and have utilized their resources 

including FDA guidance documents and recognized standards, CDRH learned 

modules and external experts if needed, and they have also reached out to an 

early feasibility representative to discuss their submission strategy. I have 

provided a link to their early feasibility guidance and CDRH learned modules 

at the end of this presentation for your reference as well as a list of early 

feasibility representatives for each division.

Second recommendation is that the submission are well planned. An 

informational meeting may be useful for novel ideas in particular. An initial 

pre-sub should include all the information described in the guidance with the 

goal to agree upon the risks in the test plan. Additional pre-subs should be 

submitted as needed, for example, if test requirements are uncertain or discuss 

the clinical protocol. And in order to help ensure an expeditious review, it is 

important that the IDE submission contains all required information. Again I 

have provided a link at the end of this presentation which contains the 

recommended content of an IDE submission.

I just wanted to make a quick note here. The use of pre-submissions to discuss 

the test plan and the clinical protocol can be very useful in the following 

ways. It can be useful when the non-clinical testing needed is unclear and be 

used to agree upon the test plan that will support an IDE submission with 

FDA and you avoid the need to redo expensive and time consuming testing.

And it may help determine appropriate clinical mitigations and reporting 

requirements in the patient population for whom the benefit risk profile 

supports inclusion into their early feasibility study. In summary, these are 

highly recommended.
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Another recommendation is that the submissions be of high quality. And by 

this I mean they contain enough information for the FDA to provide valuable 

feedback, the contents are well organized and navigable and high quality 

scientific discussion and evidence has been provided. =

And our last recommendation is that the sponsor is able to describe why 

additional non-clinical testing will not be informative and that a human 

clinical study is appropriate. There is a clear identification of potential risks 

and how they will be addressed be that be it non-clinical testing, clinical 

mitigations and/or reporting. An explanation is provided for why the plan is 

sufficient and it's helpful to explain what can and cannot be learned from the 

bench test and animal models and why any information to be leveraged is 

directly applicable to this study. And lastly it may be helpful to list which tests 

will be done to support the early feasibility study versus which will be done to 

support a later study if applicable.

Next I would like to go over some common questions that we received. The 

first question is, is EFS for novel technology only and the answer is no. Early 

feasibility studies are just small studies used to gather information when there 

is significant unknowns and they can be used for a variety of reasons: to study 

a novel device, to study an expanded device, expanded access or to support 

new indications for a marketed device. When is a good time to talk to FDA 

about an early feasibility study? The good time to talk is after you have 

established through general device design intended use and what information 

you would like to gather from the early feasibility study but before expensive 

and time consuming non-clinical testing has been started. Also, it is 

recommended to communicate with FDA informally throughout the 

development process to optimize submission efficiency.
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The guidance document contains an optional risk assessment template. When 

and how is this used? This is called a device evaluation strategy table. This 

table describes what the device is supposed to do, how it may fail, what would 

be the result of the failure and how the chance of failure has been reduced and 

clinically mitigated. It can be helpful if you do not currently use another 

method for assessing risk. It should contain a high level description of risks 

not as detailed as an FMEA but more from the clinician's perspective. And the 

intent is to link primary risks together with risk mitigations.

Next I would like to go over some tips. First tip is that if you're iterating your 

device to keep samples of previous generations. They may be useful in the 

future for establishing biocompability equivalents, for example. Second tip is 

to keep clear and detailed records of the testing completed with each device 

iteration. This ensures that a detailed description of the device iteration is 

included in the protocols and this may help leverage information in future 

submissions.

If you would like to use test results that were not obtained per standard FDA 

recommendations, we recommend that you provide an explanation for why 

the data is sufficient. For example, if your animal study is intended to support 

device safety and deviates from the good laboratory practices, we recommend 

that you tabulate each part of the regulations, list how the study deviates and 

how you will ensure data integrity and minimize bias. Of note, only animal 

studies intended to support device safety are required to address the good 

laboratory practices and the EFS guidance this discusses how non-GLP data 

may be used as long as the deviations from GLP do not compromise the 

ability of the results. And I've provided an FDA guidance link for your future 

reference.
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I'd like to expand on this a little bit more. Again if your animal study is 

intended to support device safety and deviates from GLP, FDA has some 

specific recommendations. And that is to include a protocol signed and dated 

by all key parties prior to initiation of the study. This would include the 

objectives, acceptance criteria and detailed procedures. It's also helpful to 

include the (unintelligible) protocol with amendments and include description 

of the animals enrolled in the study and their final designation.

It's also helpful to include the quality measures that have been taken and an 

explanation of how data integrity has been ensured. QA personnel to monitor 

the study are important and may be in the some company but organizationally 

separate and independent of those engaged in the study. And lastly, it can be 

useful to provide animal facility licenses, accreditations and assurances.

My last tip is to understand that FDA feedback is not a directive. It is 

information for your consideration into this (unintelligible) for further 

discussion. Frequently, further explanations provide clarity around a given 

FDA concern or context around the decisions made by the sponsor. So when 

FDA sends feedback or deficiencies it should be seen as the start of a 

conversation and an opportunity to provide clarity.

This slide provides several links for your reference. The early feasibility 

guidance provides a general overview of the program. The CDRH learn 

modules provide more detailed information about the program and there are 

several additional links that you might find useful. This slide contains contact 

information for all members of the early feasibility studies program including 

myself, our EFS medical advisor Dr. Andy Farb, and representatives from 

each division as well as the Office of Science and Engineering Labs. The 

acronyms in the left most column represent the various divisions. That's all I 

have for our first topic and I am happy to take any questions at this time.
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Irene Aihie: Thank you Carla. We will now open the line for questions on early feasibility 

studies. We have approximately 25 minutes for questions before we begin our 

next presentation.

Operator: At this time if you wish to ask a question on the phone line, please ensure 

your phone is unmuted, please press star followed by the number one and 

record just your name clearly when prompted. Once again please press star 

followed by the number one if you wish to ask a question and questions will 

take one moment to come into queue. Please stand by. Questions are coming 

into queue. Please stand by for our first question. Our first question will come 

from (Raj Patal). Your line is open.

(Raj Patal): Yes currently how are you protecting and promoting public health right now?

Carla Wiese: Maybe I think perhaps you're referring to how are we ensuring patient safety 

in these studies? And I can certainly answer that question. The early 

feasibility studies are conducted still under the standard IDE regulations and 

the early feasibility guidance talks about some specific provisions that are 

used to ensure patient safety. For example, there's very specific language in 

the early - in the informed consent document that about what type of study 

this is, about regarding the fact that there's some limited information currently 

known about how the device will perform, etcetera. There's also usually more 

patient monitoring procedures and assessments that are conducted during the 

study and a lot of times more frequent reporting to the FDA is needed in order 

to reach an IDE approval. So in that way, we help ensure patient safety. And I 

hope that answers your question.

Irene Aihie: Thank you.
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(Raj Patal): Okay thank you.

Operator: Our next question will come from (Jennifer Farrington). Your line is open.

(Jennifer Farrington): Hi. On one of the slides you indicated that it's helpful to contact the FDA

informally throughout the process. How do you go about doing that?

Carla Wiese: That's a great question. As soon as the FDA submitted a submission, you 

know, your file will go to a specific branch with a specific lead reviewer 

who's responsible for managing your file. So what we usually recommend is 

for you to reach out to her if you have any questions about say what the next 

logical steps are is a good starting point.

(Jennifer Farrington): Okay great. Thank you.

Operator: And once again as a reminder, do please press star followed by the number 

one if you wish to ask a question. Please stand by for our next question. Our 

next question will come from (Abdel Haline). Your line is open. (Abdel) your 

line is open. You may be on mute.

(Abdel Haline): Yes sure. So my question is does this apply to companion diagnostics for 

drugs? For example, can this early feasibility study - can early phase one 

clinical trial be used as early feasibility study of companion diagnostics?

Carla Wiese: Yes I would suggest that you reach out to OIR for more specifics. It's 

somewhat of a detailed question that may be a little bit out of the scope of the 

talk today.

(Abdel Haline): Sorry what did you say? I didn't hear you.
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Carla Wiese: I would recommend that you reach out to OIR for more specifics.

(Abdel Haline): No I'm trying to say, for example, if we are developing a drug in phase one 

and would like to use a develop test for patients enrollment. Does early 

feasibility - does this phase one serve as early feasibility study and do we need 

to do any submission to FDA?

Carla Wiese: Well I mean it sounds like you might be talking about a combination product.

(Abdel Haline): Yes.

Carla Wiese: So in that case, the different centers operate a little bit differently and I think 

that's somewhat of a specific question. What we can do is we've attached -

we've included a Web site that you can go too - sorry an email link that you 

can go to with questions via our Division of Industry and Consumer 

Education. It's included in this presentation. But I think that your - it would be 

best to direct your question there to get a better answer.

(Abdel Haline): All right. Thank you.

Operator: Please stand by for the next question. I do believe our next question will come 

from (Paris Chowdry). Your line is open.

(Paris Chowdry): Thank you. If a clinical trial is planned are early feasibility studies still 

required?

Carla Wiese: Could you repeat the question? I couldn't hear you very well.

(Paris Chowdry): If a clinical trial is planned for a product, is the early feasibility study still 

required?
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Carla Wiese: So I guess the answer is sometimes it is and sometimes it isn't. It depends sort 

of on the specific situation.

(Paris Chowdry): Thank you...

Owen Faris: This is Owen Faris. So there are certainly times when we feel that we know 

enough about the technology that's being studied, the way it's going to be 

studied, the general safety and effectiveness profile of the device such that it's 

appropriate to move straight into a pivotal study. That might be particularly 

common say if it's evolutionary change from a product that we're already 

relatively comfortable with. But there are many other products which are more 

novel in their nature where an early feasibility study or some sort of small

study is needed to establish basic safety and usability and sometimes the 

patient populations for the device where by a small study is needed before it 

would be appropriate to move into that larger study. So it's really a case by 

case sort of situation.

(Paris Chowdry): Okay. Thank you.

Operator: I do believe our next question will come from (Catherine). Your line is open.

(Catherine): Yes. Out of the potential to reduce some of the pre-clinical or non-clinical 

study requirements for an EFS, is there any difference in the review process 

between an EFS and a normal feasibility study IDE?

Carla Wiese: Yes there's really no difference between the review processes. We try to be 

more interactive but besides that we're - it's really run like a standard IDE.

(Catherine): Thanks.
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Irene Aihie: Thank you for your question. Operator do we have any more questions on the 

line?...

Operator: Our next question - we do. Our next question will come from (Diana). Your 

line is open.

(Diana): What is the expectation for researchers or sponsors to develop their 

investigational device using design controls? How thorough and to what 

extent are you expecting design controls to be implemented and documented 

for early feasibility study clinical devices?

Carla Wiese: That's an excellent question actually. There isn't currently a set standard or 

expectation for the level in which that documentation needs to be completed 

and I think it also is a little bit case dependent on depending on what type of 

device and what types of quality control mechanisms should be in place 

etcetera, etcetera. So actually today it's really left up to the sponsor to 

determine at what level of documentation they need. So I hope that answers 

your question.

(Diana): Thank you.

Operator: Our next question I believe will come from (Karen). Your line is open.

(Karen): Hi. My question is for software in early feasibility. Is there any type of 

delineation between how much software is required to be submitted for an 

early feasibility study for a device that has software in it? It's not a total 

software product but it's a part of the device versus a straight feasibility IDE.

So how much - is there a list of documentation that's required for an early 
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feasibility study for software versus an IDE for a feasibility study for

software?

Carla Wiese: So again it's going to depend a little bit on the risk profile and whether or not 

the risk can be mitigated in the clinical study. So there's always an option to 

potentially defer a little bit of the testing later on. There just has to be kind of 

a rationale set up for that, sort of what we talked about a little bit about this 

earlier in the presentation. So again it's a little bit case dependent but there's an 

option for that such as, as long as there's an adequate rationale provided for 

deferring any type of testing.

(Karen): Is it dependent on the level of concern?

Carla Wiese: The level of concern, whether or not patient protection measures are in place 

or different clinical mitigation strategies and etcetera.

(Karen): Thank you.

Operator: And once again as a reminder, do please press star followed by the number 

one to ask a question here on the phone line. And again do please unmute your 

phone and record your name. Our next question comes from (Harvey). Your 

line is open.

(Harvey): We had requested an early feasibility study from the FDA and they insisted 

that an animal study be done instead. The problem with doing an animal study 

is there is no animal model. And if we were to do an animal study, we would 

have to redesign the device to fit the animal in which case the results in the 

animal study would not equate to the design for a human. Where do we go 

from here? Is there anybody we can talk to like an ombudsman or somebody?
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Owen Faris: So this is Owen Faris. I'll take that. So, you know, I think this gets back to a 

point that Carla made about deficiencies in letters from IDEs and feedback 

and pre-submissions. It's not necessarily directives. It's based on the 

information we have at the time providing feedback hoping to engage in a 

conversation. Sometimes our perspective is altered by feedback that we get 

from sponsors like you. And so, you know, the first thing I would strongly 

urge you to do is engage with the review team that you received that feedback 

from and try to understand their perspective, convey your own perspective.

That may be best done through the pre-submission process.

But, you know, our teams are very eager to get to the right answer. And if you 

have information that shows that we haven't gotten there yet, we're definitely 

open to hearing that. There is a formal appeal process to engage in if you've 

explored the working with the review teams and that didn't get you to the end 

goal. But our first encouragement is really to work with the review team, 

provide them more information if you think that there's information that they 

haven't had yet and go from there. And we're happy to engage and Carla's 

email is on the slide that's up right now. And if you'd like to engage with us, 

we can certainly make sure that that conversation with the review team can 

happen.

(Harvey): Thank you.

Operator: Again do please press star one if you wish to ask a question. Please stand by 

for any further questions.

Irene Aihie: Operator are there any further questions?

Operator: We do have some additional questions coming into queue. Please stand by.

We do have a question on the line from (Debbie). Your line is open (Debbie).
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(Debbie): Yes. I'm wondering once the EFS IDE has gone in, how do the EFS staff 

participate in the process? Are they in the phone calls, at the meetings? Are 

they the project managers or participants? What's the role of the EFS staff?

Carla Wiese: So right now we ask the review teams to include their early feasibility 

representatives in all of the meetings associated with their early feasibility 

study files. And in that way they can sort of ensure that the EFS spirit is taken 

into consideration, communicate any issues to me that may be resolved and 

help the team in the decision-making processes.

(Debbie): Right. Thank you.

Operator: And next we have a question from (Fletcher Wilson). Your line is open.

(Fletcher Wilson): Hi. Thank you. Assuming a company has gone through the pre-submission 

process and has agreed on a test plan with the FDA, is there an opportunity for 

the purpose of timeline contraction to actually have the submission of the IDE 

occur while some of the longer term testing items are still ongoing with the 

understanding that no, you know, testing will begin until all tests have passed?

Carla Wiese: So there certainly is an option and there's also the contingent approval option, 

which is if you agree upon the test protocols and test methods and acceptance 

criteria you may be able to implement something during the early feasibility 

study assuming you've already come into agreement between the sponsor and 

the FDA. So there's some options to facilitate what I think you're going for 

there.

(Fletcher Wilson): Okay. Thank you.
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Carla Wiese: Sure.

Operator: Our next question will come from (Eric). Your line is open.

(Eric): Hi. Thanks. What type of labeling is required for an EFS? And I'm talking in 

terms of aside from a part number or a serial number for say an implantable 

device. I'm talking in terms of either an IFU or a manual or instructions.

Carla Wiese: Yes sure. The labeling requirements are the same as for any other 

investigational device.

Owen Faris: So the device would need to be labeled as investigational. We would certainly 

look at any instructions that are provided to investigators to make sure that 

they are adequate. You know, really it's the same as what we would look for 

in any other study to make sure that patients are protected and that adequate 

information is being provided to ensure this application.

(Eric): Perfect. Okay thank you.

Operator: And we additionally have a question from (Hasan). (Hasan) your line is open.

(Hasan): Yes. My question is (unintelligible) the early feasibility study for it seems like 

the guidance is specifically targeting the non-finished device. So you can do a 

feasibility study and get some feedback from the FDA. What if you have a 

final device, it's considered the final device? Can you just go to an IDE 

directly without doing a feasibility study?

Carla Wiese: Do you mean going directly into a pivotal study?

(Hasan): That's correct yes.
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Carla Wiese: In some cases that's possible. It's a little bit case dependent. But there are 

situations where that happens certainly.

Owen Faris: Yes really it depends on what is our knowledge base in terms of our 

knowledge of the risks and the benefits of the device. Do we know enough at 

this point to say that it's appropriate to expose subjects, many subjects, in the, 

you know, in a pivotal study to that device in the way that it's being proposed?

Or do we need to see that device being evaluated in a smaller patient cohort 

under very tight controls and maybe additional risk mitigations to make sure 

that patients are protected as we learn more. And that's really the model of 

early feasibility and traditional feasibility studies. Sometimes they are 

required by us before a pivotal study would start even if you know what the 

final device design is simply because we need to be assured that you are -

have learned enough to move into that larger study and under particularly tight 

controls generally is the nature that we're protecting patients.

(Hasan): Thank you. And a follow-up question to do an early feasibility study I guess.

I'm assuming the process we should just go through the pre-submission 

process to start a discussion with the FDA?

Carla Wiese: Yes that's recommended.

Owen Faris: You know, and we've heard a couple of people say early feasibility study or 

an IDE. We just want to clarify an early feasibility study is an IDE. It's one 

type of IDE but it goes through the same IDE process as every other IDE.

(Hasan): Thank you.
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Irene Aihie: Thank you. Thank you for your questions. If you had questions about early 

feasibility studies that we were unable to get to, please use the contact 

information provided on the slide presentation to reach us. Carla will now 

present on the draft guidance FDA categorization of investigational device 

exemption, IDE devices to assist the Center for Medicare and Medicaid 

Services, CMS, with coverage decisions. Following the presentation, we will 

give you the opportunity to ask a question about this guidance. As a reminder, 

available to assist with the Q&A portion are other subject matter experts from 

the Office of Device Evaluation here at CDRH and Rosemarie Hakim from 

the Centers for Medicare and Medicaid Services. Now I give you Carla.

Carla Wiese: Thank you very much. So the agenda for this presentation is the following. I 

would like to discuss why IDEs are conducted and why they are categorized, 

why there is new guidance related to CMS categorization, what the changes 

are between the old policy and the new policy are, considerations when 

changing from category A to category B, how a category designation may 

affect coverage in a study, and other factors that may impact coverage. Of 

note, I've also included links to this draft guidance and a relevant CMS Web 

site for your reference at the end of this presentation.

So why are IDE studies conducted? An investigational device exemption 

allows an investigational device to be used in a clinical study in order to 

collect safety and effectiveness data. FDA approval of an IDE submission 

indicates that FDA has determined that the follow - the sponsor has provided 

adequate data to support initiation of the study, there are no subject protection 

concerns to preclude initiation of the study after IRV approval, and that the 

benefit risk profile for the study is favorable.

Generally an IDE study is conducted to answer outstanding questions about 

safety and effectiveness. However, the extent to which initial questions of 
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safety and effectiveness are already addressed depends on many factors and 

this needed to be communicated from FDA to CMS. For this reason an 

Interagency Agreement between CMS and the FDA was made in 1995 to 

support CMS’ decision making for coverage. As part of this agreement FDA 

signed the device with an FDA approved IDE to one of two categories.

Experimental investigational which is Category A; or a non-experimental 

investigational which is category B.

This agreement allowed for expanded coverage to include some 

investigational devices.

A category designation was to be based on the extent to which initial 

questions of safety and effectiveness have been answered. Specific criteria 

were defined in the 1995 Interagency Agreement for how FDA would 

determine the appropriate category.

The categorization has been used by CMS as part of its determination of 

whether or not items and services meet the requirements for Medicare 

coverage.

So why is there new guidance related to CMS categorization now? The 

previous FDA policy regarding categorization did not adequately articulate 

criteria that are relevant to certain studies such as feasibility studies.

The previous policy did not contain sufficient guidance regarding how a 

category designation may change from A to B. And the previous criteria did 

not consider all regulatory pathways such as the de novo submission.
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Some additional factors include that CMS changed from local Medicare 

administrative contractor review and approval of IDE studies to a centralized 

review and approval of IDE studies effective January 1, 2015.

Interactions between FDA and CMS since that time have highlighted a need 

for changes to categorization in order to improve consistency.

This table shows what has changed or remains the same between the old 

policy and the draft guidance. The changes include the following.

In the 1995 Interagency Agreement, detailed criteria were used to designate an 

IDE device category. In this draft guidance the proposed criteria have been 

simplified to ensure that devices fall into the correct category.

In the 1995 Interagency Agreement there was limited or no visibility to how a 

category change may occur as knowledge is gained. And this draft guidance 

provides an explanation of how a category change may occur.

And in the 1995 Interagency Agreement no examples were provided. In this 

draft guidance we provided several examples that provide clarity.

There are also several items that remain the same. First the FDA review Team 

still makes the category designation. The category designation is still to be 

based on the degree to which initial questions of safety and effectiveness are 

resolved.

And the categorization will then be used by CMS as part of its determination 

of whether or not items and services will be covered. And this has not 

changed.
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As a reminder, draft guidance is proposed documentation not yet ready for 

implementation. This draft guidance was issued on June 1, 2016 and the 

comment period closes August 1, 2016.

If you would like to provide comments to the draft guidance please go to 

www.regulations.gov and the docket number for the guidance is FDA-2016-

D-1159.

Next I would like to discuss the policy included in this draft guidance. The 

draft guidance includes definitions of Category A and Category B which has 

been copied from the regulation and had not been changed in any way. A 

Category A definition, according to the regulation, is the follow.

A device for which absolute risk of the device types has not been established.

But its initial questions of safety and effectiveness have not been resolved and 

the FDA is unsure whether the device type can be safe and effective.

Some of the next slides are challenging to digest so I will read through them 

and pause after some of them so that you may absorb the material.

Regarding Category A, FDA intends to consider a device to be in Category A 

if one or more of the following criteria are met.

No PMA approval (unintelligible) clearance or de novo request has been 

granted for the proposed device or similar devices. And non-clinical and/or 

clinical data on the proposed device do not resolve initial questions of safety 

and effectiveness.

The second criteria is that the proposed device has different characteristics 

compared to a legally marketed device. And information related to the 
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marketed device does not resolve initial questions of safety and effectiveness 

for the proposed device.

Available non-clinical and/or clinical data on the proposed device also do not 

resolve these questions.

The third criteria is that the proposed device is being studied for a new 

indication or new intended us for which information from the proposed or 

similar device related to the previous indication does not resolve initial 

questions of safety and effectiveness.

Available non-clinical and/or clinical data on the proposed device relative to 

the new indication or intended use also do not resolve these questions.

Next I will go over an example of a category situation. A device is completely 

novel and has no or limited previous human use and our initial questions of 

safety and effectiveness.

There is adequate non-clinical information to support initiation of an early 

feasibility study that will provide data to inform potential device design or 

procedural improvements.

Now I’ll go over a second example. An already approved or clear device is 

being evaluated for a new intended use or indication wherein the device will 

be placed in a different anatomical location.

The device’s technology is unchanged from what was initially approved.

However, it is uncertain as to whether the device can be safety placed in the 

new anatomical location and whether the device can also be effective in the 

new anatomical location.
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Therefore there are inadequate data to resolve the initial questions of safety 

and effectiveness relative to the new intended us or indication.

Next I’d like to go over Category B. The Category B definition, according to 

the regulation and as stated in the draft guidance is the following.

A device for which the incremental risk is the primary risk in question, that is 

initial questions of safety and effectiveness of that device type have been 

resolved or it is known that the device type can be safe and effective because 

for example, other manufacturers have obtained FDA pre-market approval or 

clearance for that device type.

FDA intends to consider a device to be in Category B if one or more of the 

following criteria are met. No PMA approval; 510(k) clearance or de novo 

request has been granted for the proposed device or similar devices.

However, available clinical data, for example feasibility study data and/or 

non-clinical data for the proposed device or a similar device solve the initial 

questions of safety and effectiveness.

The second criteria is the following. The proposed device has similar 

characteristics compared to a legally marketed device. And information 

related to the marketed device resolves the initial questions of safety and 

effectiveness for the proposed device.

Additional non-clinical and/or clinical data on the proposed device may have 

been used in conjunction with the leveraged information to resolve these 

questions.
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And the last criteria for Category B is that the proposed devices is being 

studied for a new indication or new intended use. However information from 

the proposed or similar device related to the previous indication resolves the 

initial questions of safety and effectiveness.

Additional non-clinical and/or clinical data on the proposed device may have 

been used in conjunction with the leveraged information to resolve these 

questions.

I’ll now go over two examples of Category B. First example is that adequate 

data has been gathered from non-clinical testing and the clinical results of a 

feasibility study such that initial questions of safety and effectiveness have 

been resolved.

A pivotal study will be initiated to provide the primary clinical evidence for 

the safety and effectiveness of the device in support of a future marketing 

application.

A second example of Category B is that an improved device will be evaluated 

for a new indication. Data exists on an approved device for another similar 

indication, and non-clinical data has also been supplied such that the initial 

questions of safety and effectiveness related to the new indication have been 

resolved.

The new study to be conducted will provide further data regarding device 

performance for this new indication.

Next I’ll discuss when IDEs are categorized. The FDA Review Team will 

make a categorization decision at the time of the first approval, be it full or 

conditional approval, of an IDE study. A categorization change will be 
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considered for study expansion or upon a request for redesignation. The 

category is included in FDA’s approval letter for the IDE.

So a few types of information that might support a category change. One is, 

non-clinical test data or external data on the technology. For example data 

from other similar devices or preliminary clinical data on that device.

Next I would like to go over an example of a change from Category A to 

Category B. Adequate data has been gathered on a device from non-clinical 

testing to completion of an early feasibility study within the U.S., as well as a 

small non-U.S. clinical study such that initial questions of safety and 

effectiveness have been resolved.

Additional data are needed to help inform a pivotal study design. Therefore a 

traditional feasibility study will be initiated.

Although the early feasibility study was originally designated as Category A, 

adequate data, as described above, has since been gathered to support a 

change to Category B for the traditional feasibility study.

In this particular example multiple studies were conducted prior to completing 

a feasibility study. However many times (unintelligible) single U.S. early 

feasibility study is completed prior to starting the next study.

Next I’d like to talk about how a categorization designation may affect 

coverage in a study. If the study is designated Category A, the device may be 

covered but routine care and services may be covered.

If a study is designated a Category B then the device and routine care and 

services may be covered.
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There are other factors that may affect coverage in a study. Some questions to 

be asked include the following.

Has a previous national coverage been made for the device type and/or 

procedure? Because a coverage decision may supersede the category 

designation.

Will the device be adjunctive to a procedure in which a coverage decision has 

been made? Again, a coverage decision may supersede the category 

designation.

Is the device relevant to the Medicare population, and have other CMS criteria 

been met? And I’ve included a link to a CMS Web site on the following slide 

for your reference. And of course there may be other factors that impact 

coverage.

Here are two links for your reference. A link to the FDA draft guidance we 

discussed in this presentation, and a link to the CMS Web site titled, Medicare 

Coverage Related to Investigational Device Exemption Studies.

I will now take questions. And as a reminder, we have (Rosemary Hakeem) 

here from CMS as well. Thank you.

Carla Wiese: Thank you (Carla). We will now open the lines for questions related to the 

draft guidance. Operator?

Operator: Thank you. Once again at this time to ask a question do please ensure you 

have your phone unmuted on your end. Please press star followed by the 
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number 1 and record just your name clearly when prompted so I may 

introduce your question.

Once again please press star followed by the number 1 if you wish to ask a 

question. And questions will take one moment to queue up. Please stand by.

Our first question will come from (Abdel Helene). (Abdel), your line is open.

(Abdel Helene): Thanks. So my question is, how this applies to companion diagnosis in 

clinical trials? My interpretation of your guidance is, companion diagnostics 

IDE is for clinical trials can be considered within Category A which is not 

reimbursed, but if the test has been already approved

For example, if you apply HRSA test for a new indication where the test has 

been approved this - can this be within Category B which can be reimbursed 

for clinical trials or not?

Carla Wiese: So the guidance applies to all IDEs. And if you have specific questions which 

it sounds like you do, I would recommend that you send via the email 

provided in the presentation.

(Abdel Helene): Thank you.

Operator: Our next question will come from (Trang Quen). (Trang), your line is open.

(Trang Quen): Hi, I’d just like some clarification. If we have - if we are trying to add in a 

new indication, that requires a clinical trial?

Owen Faris: So this is Owen - yes. So if you are studying a device or a new indication

that’s not approved then if it does fall under the purview of something that 
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may require an IDE, depending on the risk profile and whether there are other 

reasons that the study be exempt.

But generally, if it is considered a significant risk device - significant risk 

study for a new indication for an approved device, yes it would require an 

IDE.

Carla Wiese: Operator, are there any further questions in queue? 

Operator: Yes, our next question will come from (Debbie Brown). (Debbie), your line is 

open.

(Debbie Brown): Thank you. I have two questions. One is, does the FDA give an automatic 

designation of Category A and B even if the company doesn’t provide any 

information related to this topic?

And then my second question was, if you get product approval after 

conducting an IDE and you have a Category a designation, to what extent 

does that affect reimbursement after approval?

Owen Faris: I will take the first part of that question and maybe (Rosemary) can take the 

second. So the first part is, every IDE that we approve or approve with 

conditions, we assign a designation.

So regardless of whether you make a case for one or the other, we’re going to 

assign a designation in that letter.

(Rosemary Hakeem): Hi, this is (Rosemary Hakeem). The question about reimbursement, so 

reimbursement is an automatic - has an FDA approval (unintelligible). So...
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(Debbie Brown): I’m sorry, we can’t hear you very well.

(Rosemary Hakeem): Can you hear me?

(Debbie Brown): No - yes. Could you try again?

(Rosemary Hakeem): I could try.

(Debbie Brown): Thank you.

(Rosemary Hakeem): Yes, so the initial - after the FDA has approved the device, the initial 

category designation doesn’t affect the reimbursement. In order to get it 

reimbursed you have to go to CMS and ask for a billing code and that’s how 

you get reimbursed.

Carla Wiese: I’m sorry, we still couldn’t hear that last sentence I think.

(Owen): We’re going to pass over a different microphone. Hold on one moment, we’re 

going to give it one more shot.

(Rosemary Hakeem): Okay, so the initial FDA ID designation no longer applies to billing after 

the FDA approves the device. You have to go to CMS to get a code in order to 

go to reimbursement for whatever it is that you’re doing.

(Debbie Brown): That answers my question. Thank you.

Operator: Our next question will come from (Laura Lund). (Laura) your line is open.
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(Laura Lund): Thank you. I also have two questions if that’s okay? The first question is, how 

- to what degree will FDA consider OUS feasibility study data or post-market 

surveillance or registry data in making a category decision?

The second question is, if a sponsor is approved for a pivotal trial, however 

FDA believe that beginning the trial, the device should be categorized as A, is 

there a potential process for pre-agreeing on a point during the pivotal trial at 

which a device can change categorization from A to B?

Owen Faris: So the first question was I think, what extent would we consider OUS data 

and registry data; other data in our decision as to what we know about initial 

questions of safety and effectiveness?

And I think the answer to that is pretty clear that we absolutely will consider 

that information that we are always trying to take a least burdensome 

approach to make best use of the information that’s available.

And so if you have meaningful information that didn’t come from a U.S. 

clinical study, that’s perfectly fine. If it’s meaningful and we can rely upon it 

we will do so. So I think that part is relatively clear.

The second part of your question was asking if we’re going to transition from 

an A to a B. Somewhere along the way, is there a clear cut point where that 

might happen? And I think the answer to that is, maybe.

So you know we are always willing to consider a Change Request in 

designation. So there certainly would be times when you might conduct a 

feasibility study it’s an A. You come in with your total study proposal, we 

now know more because of the information gained in the feasibility study and 

we determine that that’s B.
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There might be another situation where you are proposing a pivotal study, 

maybe without having done a feasibility study. Maybe we think that’s 

appropriate, but we do what we call a phased or staged pivotal study where a 

certain number of patients are exposed to the device through the investigation 

initially. We see what happens with that before we broaden that study.

That may be a reasonable transition time to consider changing from an A to a 

B as well.

But then there are also times when new information becomes available and 

you as a sponsor could come to FDA and say, new information is available.

We’d like to make a case that this should be a B now. And we would 

definitely entertain that discussion.

(Laura Lund): Thank you.

Carla Wiese: Hi this is (Carla). I just wanted to add one thing. I think just keep in mind that 

we can always - you can always communicate with your review staff and 

discuss which open questions there are about safety and effectiveness in order

to help with predictability.

(Laura Lund): Okay, thank you.

Carla Wiese: We’ll take our next question.

Operator: Our next question will come from (Cathy). Your line is open (Cathy).

(Cathy): Hi. I was just wondering if you could give us an example of what answering 

an initial question of safety and efficacy is. I know in certain final questions 
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regarding safety and efficacy would require a pivotal. But is there any 

guidance on what threshold you might have to meet to answer an initial 

question of safety and effectiveness?

Carla Wiese: There is no guidance or threshold because it’s such a large variability in the 

questions of safety and effectiveness that could potentially need to be 

answered.

I can give you an example of like a relatively easy question of safety that 

could be answered. Let’s say for example you are investigating an 

implantation method and there’s a concern about whether or not that specific 

method for implanting that device in a specific location will be safe.

That’s something that you may be able to easily answer by verifying 

throughout the clinical study that the implant will end up where it was 

intended. And that is the one question of safety. There are probably, you 

know, several in any given study.

But that particular question could potentially be answered relatively quickly.

And of course there are other questions that may take much longer to resolve.

Owen Faris: So this is Owen. I think I’ll expand on that a little bit. Thanks (unintelligible).

So I think - you know I think you’re getting to sort of the core question here 

about what does it mean to answer initial questions on safety and 

effectiveness. And I think, you know, we have many examples that are easy 

on either side of the fence. And then we have some that are right on it.

And so, you know, when we have - when we see a novel device in a feasibility 

or early feasibility study, there are many new questions. We may not know 
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exactly how it’s appropriately going to be tested. We’re going to be learning a 

lot along the way. That’s a pretty clear no, we don’t know the answer to initial 

questions of safety and effectiveness.

We also see many studies that are iterative changes relative to very established 

products. And so sometimes those studies go right into pivotal. We know a lot 

about how to design them. We know a lot about the end points, and we know 

a lot about the kinds of things that might go wrong.

And we tested a lot of that through animal and bench data. And so those kinds 

of devices are pretty clearly in the B category.

And then we have a lot that are in the middle somewhere. And those are the 

ones that, you know, we are trying with the design of this guidance to give 

some flexibility and interpretation and room to have a discussion with 

sponsors to figure out whether we know enough to go from an A to a B or 

whether we’re still in the place of saying we don’t know enough yet and we’re 

going to have it stay in the A category.

And so we have a lot of devices that are substantially different from the

technologies that are out there but also have some similarities. And so the 

extent to which we can rely on what we know or the extent to which things 

remain unknown and must be answered vary to a great extent and can - you 

know, requires a great deal of consideration and discussion.

And one of the ideas about this guidance is that we wanted to be flexible 

enough such that that discussion can be held and the right decision can be 

reached.

Carla Wiese: Okay, thank you.
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Operator: Our next question will come from (Laura Hinsey-Russell). Your line is open.

(Laura Hinsey-Russell): Yes this is a question regarding the safety and effectiveness. Will IDE 

and other testing start to move towards recognizing variation in 

biocompatibility among patients under a precision medicine framework?

In the future, will you be looking at basket studies to look at allergic and 

autoimmune reactions to device materials which can help minimize the cost of 

adverse events to patients and recalls to manufacturers if certain people can’t 

tolerate them and others can?

Owen Faris: That’s a great question but I’m going to say that that’s a little bit out of scope 

of the talk we’re giving today. And to answer that question I think we’d want 

to have other experts in the room. So I would say that if you have a specific 

question in that area that you send it to that e-mail address on the last slide 

there, and we’d be happy to engage with the right people.

(Laura Hinsey-Russell): Okay, thank you.

Operator: Our next question will come from (Catherine). Your line is open.

(Catherine): Yes, if the investigational product is covered by CMS and then that product 

goes on to be approved or cleared, is there an automatic CMS coverage for the 

commercial product or is it more likely to be covered? Or are the two 

coverage decisions independent from each other?

Carla Wiese: Okay so in order to be covered in CMS, not only do you need to go through 

the IDE process for approval but you also have to have a payment code. And 

so once the IDE is FDA approved or is no longer an IDE, you use that code 
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for billing. Sometimes things rise to the attention of our Medicare contractors 

or to our central office and we do a national coverage decision or a local 

coverage decision.

And in that case, we may re-evaluate whatever it is that was tested under the 

IDE and apply conditions to coverage. But in general things go through and 

get billed if they have a billing code. And that’s up to the sponsor to get that 

code.

Owen Faris: So it’ll be covered.

(Catherine): So for example if we get an ICD-10 code and we are - the investigational 

product is covered for the study, if the product is approved or cleared, then the 

coverage is automatic for commercial products?

Carla Wiese: As long as there aren’t any Medicare policies that restrict coverage. 

(Catherine): All right. And a second related question is getting CMS coverage for the 

investigational product, is that less lengthy than going through like an NTAP 

application or whatever applications you need to go through to get coverage 

for a commercial product? Is it a quicker process?

Carla Wiese: Well since I don’t work for the FDA, I can’t do that comparison for you.

(Catherine): All right.

Carla Wiese: So are you talking about coverage during a study or coverage...

(Catherine): Yes, yes.
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Carla Wiese: ...after the (unintelligible)?

(Catherine): Yes, yes, it’s coverage - is it a quick process to try and go through the process 

and learn whether or not you’re going to be covered or not covered for an 

investigational product during the study? How long does that typically take?

Carla Wiese: Well we had tried to do it within 30 days. Sometimes there are problems and 

issues and we have...

(Catherine): All right.

Carla Wiese: ...to have discussions, but...

(Catherine): All right.

Carla Wiese: ...once you submit it and that – it was in the previous slide – (Carla) gave you 

the address, the instructions on how to submit an IDE study for approval and 

the materials you need to submit to the IDE site. That’s all on our Web.

(Catherine): All right, thanks.

Carla Wiese: You’re welcome.

Operator: As a reminder, to ask a question please ensure your phone is unmuted. Please 

press Star followed by the number 1 and record just your name clearly when 

prompted. Our next question I believe will come from (Mary Ann Bruner).

Your line is open.

(Mary Ann Bruner): Hi, thank you. How does this apply to non-significant risk devices that don’t 

require an IDE to the FDA?
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Carla Wiese: So the FDA doesn’t assign a category to those. If it’s a non-significant risk 

device, and the FDA has not assigned an IDE, then what you generally have to 

do is to go to the Medicare contractor to ask for coverage.

(Mary Ann Bruner): Okay, thank you.

Operator: And our next question will come from (Debra). Your line is open.

(Debra): Thank you, and I’m sorry I didn’t quite hear the last question so maybe it’s 

already been answered, but for IVD studies in which it’s exempt from the IDE 

regulations, will CMS still entertain coverage? And how would we get some 

kind of designation?

Carla Wiese: So again I think you’re referring to non-significant risk devices that we were 

just talking about. If it’s in a clinical study, you should go to the local 

Medicare contractor to discuss coverage.

(Debra): Okay, so even if it’s exempt from IDE regulations altogether, we could still go 

to CMS.

Carla Wiese: Yes. But we don’t review it in the IDE process.

(Debra): Okay, thanks.

Operator: Once again to ask a question please press Star followed by the number 1 now.

Please stand by for further questions. Once again please press Star 1 for 

questions. Please stand by for additional questions. Additional questions are 

coming in. One moment. Our next question will come from (Jessica Stern).

(Jessica) your line is open.
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(Jessica Stern): Thank you. With regards to submitting a request to CMS for review and 

approval of an IDE study, whose responsibility is that for the submission? Is it 

the study sponsor or the study sites that are participating in the study?

Carla Wiese: Okay so I think you’re asking this because in the old process, the study sites 

submitted a request to a local Medicare contractor.

(Jessica Stern): Yes.

Carla Wiese: Well nowadays the most efficient way to do it is for one entity to submit it 

under one IDE number. And then if we approve it, we put that IDE number 

along with a ClinicalTrials.gov number onto our Web site and that study is 

now approved for every site.

So if we’ve seen that another site is already submitting something that was 

submitted by the sponsor, we’d already approved it, we just say well you 

didn’t need to do that.

(Jessica Stern): Okay, thank you. And a follow-up question to that, with the older system, the 

study sites were responsible for determining whether or not CMS coverage 

was required for the hospital and/or the institution and/or the physician for a 

particular study.

So within one study, sponsored study, some sites would have CMS approval 

and some wouldn’t. Is that still the same case with the current system?

Carla Wiese: No. Everybody’s covered if it’s approved, if it’s on our Web site. Some of the 

Medicare contractors will ask for material, but they can’t override our 

decision so they can’t non-cover it.
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So what really happens procedurally is once we’ve put your study’s IDE 

number up, the local contractors actually change their computer systems to 

accept it at each site individually, which is why they might want more 

material from each site just to ensure that that site’s really in the study.

(Jessica Stern): Okay, thank you.

Carla Wiese: You’re welcome.

Operator: And once again as a reminder please press Star followed by the number 1 if 

you wish to ask a question. Our next question will come from (Ashwini 

Jacob). Your line is open.

(Ashwini Jacob): Yes hi, I have a question. I currently have an IDE that’s categorized as B-3, 

and I don’t see any numerical designations in the guidance document, and I 

was wondering if you could elaborate on what the definition for that category 

is.

Owen Faris: Sure. So that was definitely part of the point for why we did what we did with 

this guidance. One of (Carla)’s early slides said that, you know, the old model 

from 1995, which you’re referring to, had some very specific criteria under 

which something would be an A or a B.

And we found that frankly that those criteria weren’t fully comprehensive and 

were a little bit limiting. And so looking back at it, you know, 20 years later, 

the feeling was that really they all come back to this fundamental question of 

what are the initial questions of safety and effectiveness and to what extent 

have they been addressed at the time of the IDE approval.
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And so we very intentionally simplified this so that it would be an A or a B 

and not a B-1, B-2, B-3, B-4 because really we felt that that was really kind of 

confining and limiting from us having the right conversation reaching the 

right decision.

(Jessica Stern): Okay, thank you. That’s clear.

Operator: Our next question will come from (Audrey). Your line is open (Audrey).

(Audrey): Hi, I have a question. Once you submitted the documentation that’s needed for 

coverage from CMS to CMS, when does that information get available public 

viewed on their Web site? How long does it take to see that on their Web site?

Carla Wiese: Yes so we have scientific people review it. And it takes a few weeks. Once we 

make a decision, we send the letter to the sponsor, whoever made the request.

And then every Friday, new approvals go up on our Web site.

So if you submitted something a month ago, and it was from Monday, and we 

decided to approve it on a Monday, you’ll see your number appear on our 

Web site on Friday.

(Audrey): Okay, thank you.

Woman: But you’ll get the letter on Monday, yeah.

Carla Wiese: Thank you. We appreciate your participation and thoughtful questions.

Today’s presentation along with the slide presentation and transcript will be 

made available on the CDRH Learn section of our Web site at 

www.fda.gov/training/CDRHLearn by Friday, July 22 under the tab How to 
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Study and Market Your Device in the section titled Clinical Studies, 

Investigational Device Exemption IDE.

Please note the FDA is not able to provide continuing education credits or 

certificates of attendance for today’s Webinar.

If you have additional questions about medical device clinical trials program, 

please use the contact information provided at the end of the slide 

presentation. Again thank you for participating and this concludes today’s 

Webinar.

Operator: Once again, with that we’ll conclude today’s conference. Thank you for 

participating. You may disconnect your lines at this time.

END