FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 1

FDA Webinar: FDA Categorization of Investigational Device Exemption (IDE)

Devices to Assist the Centers for Medicare and

Medicaid Services (CMS) with Coverage Decisions

Moderator: Irene Aihie

January 16, 2018

3:00 pm ET

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

listen-only mode until the question and answer portion. If you would like to 

ask a question at that time, please press star followed by 1 on your touchtone 

phone. You’ll be prompted to record your first and last name. 

Today’s conference is being recorded. If you have any objection, you may 

disconnect at this time. 

Now I’ll turn the call over to your host, Irene Aihie. Thank you, ma’am. You 

may begin. 

Irene Aihie: Hello and welcome to today’s FDA webinar. I am Irene Aihie of CDRH’s 

Office of Communication and Education. On December 5, 2017 the FDA 

issued the final guidance titled FDA Categorization of Investigational Devices 

Exemption Devices to Assist the Centers for Medicare and Medicaid Services 

with Coverage Decisions. The purpose of the guidance is to modify the FDA’s 

policy on categorization of IDE devices used in clinical investigations. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 2

Today, Ken Skodacek will present an overview of the final guidance 

document. Following the presentation, we will open the line for your 

questions related to information provided during the presentation. 

Additionally, there are other subject matter experts here with us today to assist 

with the Q&A portion of our webinar. 

Now, I give you Ken. 

Ken Skodacek: Thanks Irene for that introduction. My name is Ken Skodacek. I work in the 

Clinical Trials Program and in the Payer Communication Task Force and I’ll 

be covering the slides for today’s presentation. 

Today’s webinar presentation is divided into six sections. First, we will briefly 

discuss the general topic of investigational device exemption and then review 

the background and rationale for the guidance. Then we will review FDA’s 

role in the overall process with a discussion of the category criteria, including 

some examples. We will then touch on the role of CMS in the process. We 

will also review how the category might change. And finally, we will 

conclude with a list of references with time for questions and answers. 

At the end of this webinar, you should have a good understanding of how 

FDA assigns a CMS category to each IDE and how this category is

subsequently used by CMS in making a coverage determination associated 

with the IDE. 

First, we would like to provide some information about investigational device 

exemptions or IDE clinical investigations. FDA processes about 250 original 

IDE applications each year. An approved IDE allows a device to be used in a 

clinical study in order to collect safety and effectiveness data. Generally, an 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 3

IDE study is conducted to answer outstanding questions about device safety 

and effectiveness. However, the extent to which initial questions of safety and 

effectiveness are already addressed depends on many factors as each device 

and situation can be somewhat unique. 

We’ll discuss the phrase initial questions of safety and effectiveness in more 

detail in the subsequent slides. You can read more about the IDE clinical 

investigation regulations in section 21 of the Code of Federal Regulations, or 

CFR, Part 812. 

Next, we’d like to provide some very basic information about FDA’s 

decision-making process for IDEs. Approval of an IDE application indicates 

that FDA has determined that the sponsor has provided adequate data to 

support initiation of the study. It also indicates that FDA has determined that 

there are no subject protection concerns that preclude the initiation of the 

study after Institutional Review Board or IRB approval. Finally, it also 

indicates that FDA has determined that the benefit-risk profile for the study is 

favorable, with the benefits and value of information being obtained 

outweighing the risks of participation. 

You can read more about these aspects of FDA’s process in and the overall 

considerations in some previously issued guidance documents, including FDA 

Decisions for Investigational Device Exemption Clinical Investigations and 

Factors to Consider When Making Benefit-Risk Determinations for Medical 

Device Investigational Device Exemptions. 

In the next part of today’s webinar, we’ll review the background and rationale 

for the guidance. This slide provides a high-level summary of what we mean 

when we talk about FDA’s categorization of an IDE and the assignment of a 

CMS category. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 4

In order to support the Centers for Medicare and Medicaid Services, or CMS, 

FDA categorizes IDE devices based on whether available data demonstrates 

that initial questions of safety and effectiveness have been resolved. Based on 

FDA’s review of the information provided by the sponsor, IDE applications 

are assigned to one of two categories: Category A, experimental devices, or 

Category B, non-experimental investigational devices. 

After our review of the relevant information, FDA communicates this 

categorization in our regulatory decision letters by assigning a CMS category. 

CMS then uses this categorization as one of several factors in its 

determination of which devices, as well as routine care and services, meet the 

requirements for Medicare coverage. 

It’s also important to be aware that there is some historical context about this 

topic in general. This slide includes some of the key milestones that have 

occurred over the past 20 plus years. FDA and the Health Care Financing 

Administration -- referred to as HCFA -- initially signed an interagency 

agreement in 1995. HCFA subsequently became and is now known as CMS. 

We will discuss the 1995 agreement in more detail on the next slide. 

In 2010, FDA and CMS established a memorandum of understanding or 

MOU. The purpose of this MOU is to promote collaboration and enhance 

knowledge and efficiency by providing for the sharing of information and 

expertise between the agencies. 

On January 1, 2015 changes were made to Medicare coverage requirements 

and CMS review procedures for IDE studies. And one of these changes 

included a shift from local Medicare administrative contractor, or MAC, 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 5

review to a centralized review conducted by the CMS Coverage Analysis 

Group, or CAG. 

The agencies established another MOU in order to streamline facilitate the 

efficient categorization of investigational medical devices which ultimately 

supports the process that CMS uses to make Medicare coverage 

determinations. Finally, on December 5, 2017 FDA issued the final document 

on this topic. 

There are three primary rationales for this guidance. First, previous FDA 

policy regarding the categorization did not adequately articulate criteria that 

are relevant to certain studies such as feasibility studies. Second, previous 

criteria did not consider all regulatory pathways -- for example, De Novo 

request. And third, previous policy did not contain sufficient guidance 

regarding how a category designation may change from A to B. 

There are two secondary rationales for this guidance. As we mentioned 

before, CMS changed from local MAC review of IDE studies to a centralized 

review 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. Together, all these rationales highlighted the 

need for an updated understanding of the process. 

Next, we will compare and contrast the key elements of the 1995 interagency 

agreement relative to the new final guidance. The first column of this table 

summarizes the elements of the 1995 agreement. The second column 

summarizes the elements of the guidance. 

There are three elements that have changed. First, the criteria have been 

simplified to ensure that the devices fall under the correct category. Second, 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 6

the final guidance provides an explanation of how a category change may 

occur. And third, the guidance provides a number of examples which should 

help to clarify how the revised criteria will be used by FDA staff. 

The table also includes three elements that are not being changed from the 

1995 interagency agreement. Specifically, these elements are that FDA review 

team makes the category designation, that the category designation is to be 

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

resolved, and that categorization will then be used by CMS as part of its 

determination for whether or not items and services will be covered. 

Now, we will review the revised criteria including in the guidance and 

highlight some examples. These criteria are the main focus of the guidance 

document and also the main focus of today’s webinar. 

Most importantly, we would like to emphasize that obtaining CMS coverage 

of an IDE clinical investigation is a two-step process. The FDA process is the 

first step. The sponsor would submit their IDE application to FDA. FDA then 

receives and reviews that application, primarily considering the requirements 

outlined in 21 CFR Part 812, the IDE regulations. 

As one small but important part of that review FDA considers the available 

information and assigns a CMS category. And that assignment is included in 

the IDE regulatory decision letter for studies that are fully approved or 

approved with conditions. 

As we mentioned previously, FDA assigns each IDE to one of two categories. 

Before we provide the definition of category A, it is important to note that 

these definitions are provided in the CMS regulations. We provided the text 

from the regulations here. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 7

Category A, experimental, is assigned for a device for which absolute risk of 

the device types has not been established -- that is, initial questions of safety 

and effectiveness have not been resolved -- and the FDA is unsure whether the 

device type can be safe and effective. Specifically, this text appears in the 

CMS regulations 42 CFR Part 405.201(b) and has not changed. 

We will now review the text in the guidance, which is our interpretation of the 

previously referenced regulations. We will walk through each of these three 

criteria individually. 

Please note than an IDE is assigned category A if one or more of the 

following criteria are met -- the first criterion for category A is no PMA 

approval, 510(k) clearance, or De Novo request has been granted for the 

proposed device or similar devices, and data on the proposed device or other 

similar devices do not resolve initial questions of safety and effectiveness and 

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

We have summarized the criterion using more concise text within the box. No 

prior approved cleared device and available data do not resolve initial 

questions of safety and effectiveness. We’ll explain how this text will help 

you to understand all the criteria momentarily.

An IDE is assigned Category A if one or more of the following criteria are 

met -- the second criterion for category A is the proposed device is being 

studied for a new indication or new intended use for which information from 

the proposed or a similar device related to the previous indication or intended 

use does not resolve initial questions of safety and effectiveness. Available 

nonclinical and/or clinical data on the proposed device or similar devices 

relative to the new indication or intended use also do not resolve these 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 8

questions and FDA is unsure whether the device type can be safe and 

effective. 

Again, we have summarized this information using more concise text within 

the box. New indication or new intended use. Available data do not resolve 

initial questions of safety and effectiveness.

An IDE is assigned category A if one or more of the following criteria are met 

-- the third criterion for category A is the proposed device has different 

technological characteristics compared to a legally marketed device, and 

information related to the marketed device does not resolve initial questions of 

safety and effectiveness for the proposed device. Available clinical and nonclinical data on the proposed device or similar devices also do not resolve 

these questions and FDA is unsure whether the device type can be safe and 

effective.

Again, we have summarized this information using more concise text within 

the box. New technological characteristics compared to approved/cleared 

devices. Available data do not resolve initial questions of safety and 

effectiveness. 

This slide summarizes the three different criteria for category A. An IDE is 

assigned category A if one or more of the three criteria are met. The first 

criterion would apply when there is no prior approved cleared device and 

available data do not resolve initial questions of safety and effectiveness. 

The second criterion would apply when there is new indication or new 

intended use, and again, available data do not resolve initial questions of 

safety and effectiveness.
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 9

The third criterion would apply when there are new technological 

characteristics compared to approved cleared devices and available data do 

not resolve initial questions of safety and effectiveness. 

Please note that in all cases, the available data including non-clinical and 

clinical data from proposed device or similar devices does not resolve initial 

questions of safety and effectiveness. In plain language, category A is 

typically assigned to devices that are new and significantly different from or 

used in different ways from devices that are already commercially available 

and already being used within our healthcare system. 

With these new devices, there is not sufficient, non-clinical and clinical 

information available to resolve initial questions of safety and effectiveness. 

Now we’d like to review two selected examples for category A from the 

guidance. One example is a device that is completely novel and has no or 

limited previous human use and there are 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 the potential 

device design or procedural improvements. 

Another example is a new device. The initial questions of safety have been 

answered with a submission of non-clinical data and short-term clinical data. 

However, additional performance data will be needed to resolve questions 

related to effectiveness. Please note the distinction between safety and 

effectiveness in this example. 

As we mentioned previously, FDA assigns each IDE to one of two categories. 

Before we provide the definition for category B, it is again important to note 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 10

that these definitions are provided in the CMS regulations. We provided the 

text from the regulation here. 

The other category is category B, nonexperimental investigational. And is 

assigned for 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 

premarket approval or clearance for that device type. 

Specifically, this text appears in the CMS regulations 42 CFR Part 405.201(b) 

and has not changed. 

We will now review the text in the guidance which is our interpretation of the 

previously referenced regulations. And we will walk through each of the three 

criteria individually. 

Please note that an IDE is assigned category B if one or more of the following 

criteria are met. The first criterion for category B is no PMA approval, 510(k) 

clearance, or De Novo request has been granted for the proposed device or 

similar devices; however, available information -- for example, feasibility 

study data -- from the proposed device or a similar device resolves the initial 

questions of safety and effectiveness. 

We have summarized the criterion using the more concise text within the box. 

No prior approved/cleared device. However, available data resolves initial 

questions of safety and effectiveness. We will explain how this text will help 

you understand all the criteria momentarily. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 11

An IDE is assigned category B if one or more of the following criteria are 

met. The second criterion for category B is the proposed device is being 

studied for a new indication or new intended use; however, information from 

the proposed or a similar device related to the previous indication or intended 

use resolves the initial questions of safety and effectiveness. In some cases, 

additional non-clinical and/or clinical data on the proposed device may also 

have been used to resolve these questions. 

Again, we have summarized this information using more concise text within 

the box. New indication or new intended use. However, available data 

resolves initial questions of safety and effectiveness.

An IDE is assigned category B if one or more of the following criteria are 

met. The third criterion for category B is the proposed device has similar 

technological characteristics compared to a legally marketed device, and 

information related to the legally marketed device resolves initial questions of 

safety and effectiveness for the proposed device. In some cases, additional 

nonclinical and/or clinical data on the proposed device may also have been 

used to resolve these questions.

Again, we have summarized this information using more concise text within 

the box. Similar technological characteristics compared to approved/cleared 

devices. And available data resolves initial questions of safety and 

effectiveness. 

This slide summarizes the three different criteria for category B. An IDE is 

assigned category B if one or more of the following three criteria are met.

The first criterion would apply when there is no prior approved or cleared 

device. However, available data resolves initial questions of safety and 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 12

effectiveness. The second criterion would apply when there is a new 

indication or a new intended use. However, available data resolves initial 

questions of safety and effectiveness.

And the third criterion would apply when there are similar technological 

characteristics compared to approved/cleared devices and available data 

resolves initial questions of safety and effectiveness. 

You might notice that the initial bullet in in each box are similar to the initial 

bullets from category A. However, please note that in all cases the available 

data, including nonclinical and clinical data from the proposed device or 

similar devices, does resolve initial questions of safety and effectiveness. 

In plain language, category B is typically assigned to devices that are not new 

and that are significantly similar to or used in similar ways to devices that are 

commercially available and already being used within our healthcare system. 

With these devices, given their similarity to other devices, there is sufficient 

nonclinical and clinical information available to resolve initial questions of 

safety and effectiveness. 

Now we would like to review two selected examples for category B from the 

guidance. One example is a device that is similar to other devices on the 

market. In this example, a new device will be studied for an indication for 

which substantial safety and effectiveness information exists from other 

similar devices of the same type that are used for the same or similar 

indication. Clinical information from similar devices and non-clinical test data 

from the new device that have been provided can answer initial safety and 

effectiveness questions regarding this indication. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 13

Another example is an approved device for a new indication. In this example, 

an approved device will be evaluated for a new indication. Data exists on the 

approved device for a similar indication and non-clinical data have also been 

supplied such that 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 the device 

performance for this new indication. 

Next, we will briefly review some aspects of the CMS process. As we 

mentioned before, obtaining CMS coverage of an IDE clinical investigation is 

a two-step process. The FDA process is the first step. Unfortunately, many 

sponsors mistakenly believe that no further action is necessary and it’s 

important for sponsors to understand that CMS has an entirely separate 

application and review process. 

This process is not the focus of the FDA’s guidance and is therefore not the 

primary focus of today’s webinar. However, we strongly encourage sponsors 

to read more about the application process and coverage criteria on the CMS 

website using the link on this slide. 

Acknowledging that you can’t click on the link during the webinar, you can 

search Google for CMS IDE coverage or Medicare coverage related to IDE 

trials. You can also review the list of approved IDE studies using the link 

within the diagram. 

Again, for clarity this slide emphasizes that there are two steps in the FDA 

process -- the FDA review process and the CMS review process. If a sponsor 

would like to obtain Medicare coverage for their IDE clinical investigation, 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 14

then we recommend that the sponsor must consider both steps and the 

associated criteria when designing their IDE clinical investigation. 

We have a representative from CMS here with us today in case you have 

questions about the CMS process. 

Ultimately there are two potential results if you request and are granted 

coverage for your IDE clinical investigation. If CMS grants coverage for an 

IDE clinical investigation that is designated as category A by FDA, then that 

designation will allow coverage of routine care items and services furnished in 

the study, but not the category A device, which is statutorily excluded from 

coverage. 

If CMS grants coverage for an IDE clinical investigation that is designated as 

category B by FDA, then that designation will allow coverage of the category 

B device and the routine care items and services in the trial. 

In both cases, it is possible to obtain coverage for routine care items and 

services. However, only category B allows for coverage of the investigational 

device itself. It is also important to note that in both cases, additional testing 

and procedures that are required by the clinical protocol, but not routine care 

items and services would not be covered by CMS. 

Next, we will discuss how the assigned CMS category might be changed. In 

some cases, the understanding of the investigational device and the associated 

support data may evolve over time. Clinical and/or non-clinical data gathered 

during the study may resolve initial questions of safety and effectiveness. 

Alternatively, an IDE that was assigned category A may have been completed, 

resolving initial questions of safety and effectiveness. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 15

The bullets on this slide elaborate on the data that may support a change from 

category A to category B. Some examples include but are not limited to peerreviewed studies on the same or a similar device, premarket or post market

data from studies conducted outside the US on the same or a similar device,

reference to commercialization of a device of a similar type, preliminary 

clinical data on the device -- for example, initial data from a staged study or a

feasibility study -- or additional non-clinical data on the same or a similar 

device may be included as supportive information. 

We’d like to review two selected examples for changing the category from the 

guidance. For the first example, a novel insertion procedure will be used to 

place an already approved or cleared device, and there are initial questions of 

safety and effectiveness regarding the novel insertion procedure that have not 

been resolved. 

In these, questions of safety and effectiveness may be answered in a short 

timeframe with a limited number of subjects in the context of a larger clinical 

study. Therefore, the device will be evaluated in a staged clinical study where 

the first stage falls under category A. 

If the initial questions of safety and effectiveness are resolved and then the 

study continues, the device may be recategorized to category B.

For the second example, a device is currently being evaluated in a clinical 

study and has been designated category A. While the study is being 

conducted, clinical study results for similar devices become available which 

resolve initial questions of safety and effectiveness for this device. For 

example, FDA staff might refer to the summary and safety and effectiveness 

document that summarizes the clinical study results for this similar device. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 16

As the final part of today’s webinar, we would like to provide some references 

and links in case you want to read more about the variety of topics that we 

have covered here today. 

Before we present the references and conclude today’s webinar presentation, 

we’d like to mention that CDRH has established a Payer Communication Task 

Force. The group facilitates early communications between device 

manufacturers, payers, and healthcare technology assessment organizations to 

potentially shorten the time between FDA approval or clearance and coverage 

decisions.

It is important to note that our focus is on coverage by both public and private 

payers once the device is commercially available outside of the IDE clinical 

investigation. Our team also coordinates the FDA/CMS Parallel Review 

program and other opportunities for public and private payer engagements. 

You can click on the link at the top of the page to learn more about our 

programs. 

You can also contact us via email if you have any questions. For general 

questions, please use our general email address. For questions specific to 

parallel review, please use the applicable email address. 

Here are some references and links that you can review later. And here are 

some additional references and links. 

This concludes my presentation. We can now open the webinar to questions, 

which we’d be happy to answer for you. In addition, we have three other 

individuals with me here today. Joining me today are Dr. Soma Kalb, Director 

of the IDE Program, Dr. Owen Faris, Director of the Clinical Trials Program, 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 17

and Dr. Daniel Canos who’s representing the Coverage Analysis Group at 

CMS. Daniel is familiar with the overall process and criteria that CMS uses in 

making coverage decisions for investigational devices. 

Coordinator: Thank you very much, sir. If you would like to ask a question, please press 

star followed by 1 on your touchtone phone. You will be prompted to record 

your first and last name and called on at your turn. Please do check that your 

mute button is turned off before recording your name. 

Should you decide to withdraw your request, please press star followed by 2. 

One moment to give participants time to queue up. 

Ken Skodacek: We do have some initial questions prepared. I’m going to turn it over to Dr. 

Soma Kalb to start us out with some of those questions. 

Soma Kalb: Thank you, Ken. The first question that we have -- these are from questions 

that we commonly received -- the first one is, “What can an IDE sponsor do 

if they disagree with the categorization made by FDA during the review of the 

IDE application?”

Ken Skodacek: Thanks, Soma for that question. So as I mentioned before, the guidance talks a 

little bit about how to make a change in that category or the process that a 

sponsor might use. What I would suggest if they want to make that change is 

they could simply pick up the phone, contact the reviewer. 

At the end of every IDE regulatory decision letter, there’s a phone number 

provided of the reviewer. Pick up the phone. Have a conversation with them 

to better understand why they assigned a certain category. And if there may be 

some additional information that wasn’t included in your original IDE 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 18

application or some additional clarification would be necessary, they could 

submit an IDE supplement and request that the IDE be recategorized. 

But the easiest way I think is initially just to pick up a phone, have that 

conversation to better understand the rationale for how we made the 

categorization. 

Soma Kalb: All right. So I have another question here, “When preparing the protocol to 

meet those FDA’s needs and CMS’ needs, how do we get feedback from those 

agencies?”

Ken Skodacek: Great question. So I think what we learned from some of our conversations 

with a lot of different sponsors, in some cases sponsors are actually going 

informally to CMS first and trying to understand what the requirements are 

from CMS. So they might approach CMS informally.

Another option would be to ask FDA to consider setting up a pre-submission 

meeting, so setting up an opportunity for FDA to give you feedback about 

your clinical trial design. And then either contacting CMS and asking them to 

join that meeting or asking the FDA staff for us to contact CMS to join the 

meeting.

In either case, I think the overall idea is to figure out how to bring FDA and 

CMS together during your pre=submission meeting when you’re planning 

your overall trial and selecting your end points, indications for use, enrollment 

criteria, and engage both agencies and allow both agencies to give you 

feedback before you design your clinical trial and before you submit your 

IDE. 

Woman: We’ll take our first question. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 19

Coordinator: Thank you. We have a question from (Kelly Gordon). 

(Kelly Gordon): Hi. For non significant risk devices meeting the abbreviated IDE requirements 

under 812.2(b), how will the sponsor know what category the device falls into 

if there’s no IDE decision letter provided? 

Woman: One second while we get that answer for you. 

Ken Skodacek: Thank you, (Kelly) for that question. What we’d like to do -- that’s a great 

question -- we’d like you to do is if you could follow up with an email to 

DICE after the end of the webinar and we’ll follow up and get a good answer 

for you. 

(Kelly Gordon): Okay. Thank you. 

Coordinator: If anyone else would like to queue up and ask their question over the phone 

line, please press star followed by 1 and record your name after the prompt. 

Soma Kalb: All right. While we are seeing if there are additional questions on the phone, 

one question that we wanted to provide some information on is, what 

additional information could be in the application to CMS?

Daniel Canos: This is Daniel Canos from the CMS Coverage Analysis Group. So Ken during 

his presentation provided a hyperlink to the CMS IDE web page that provides 

details, what is required in the submissions. Sponsors with FDA, approval 

letters dated January 1, 2015 or after can submit a request.

Many times we get requests from sites, individual investigator sites, but we 

actually require the sponsor of the study to submit those. We’ll redirect those 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 20

to the actual sponsor. We require an FDA approval letter, IDE study of 

protocol, the IRB approval letter, national clinical trial number, and 

supporting materials. 

Also listed on the site are the ten criteria that are required to be met for CMS 

coverage. And as you’re asked what’s being included in protocol, that would 

be helpful for our review. Many times, study protocols and coverage request 

letters don’t provide a detailed study protocol that describes the method and 

timing of release of results for all prespecified outcomes. And also their 

release of negative outcomes that should be hastened if the study is terminated 

early. 

The protocols will cover release of the data to the FDA, but CMS makes its 

decisions based on publicly available information, so we require the protocol 

to detail how such findings will be published, put in the public realm. 

Another element that at times can be lacking within the study protocols that 

facilitate our review is also covered in the criteria, which is number ten. The 

protocols need to describe how Medicare beneficiaries may be affected by the 

device under investigation and how the results are or are not expected to be

generalizable to our population. We’ll at times turn down IDE protocols 

where for coverage where it is not clear how the device actually affects our 

beneficiary population. 

Woman: Thank you. We’ll take our next question. 

Coordinator: Thank you. We do have a question from (Chandra Branham). Your line is 

now open. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 21

(Chandra Branham): Hi. This is (Chandra Branham) from AdvaMed. And I think this question 

is probably for Daniel Canos. But I wondered if you could speak to the 

experience of those devices that transition from category A to category B. I 

know the guidance was just finalized, but the program has been in effect for a 

while. Have you seen devices actually make that transition? Or has that 

happened yet? I’m curious what the experience has been.

Daniel Canos: Thank you. Very good question. So we have worked with sponsors and the 

FDA on devices that have transitioned from the category A and category B. 

As Ken mentioned during I think the first response to the first question, that 

FDA as well as CMS are open to, you know, collaboratively and interactively 

reviewing such data.

And when we approve those devices, the studies, CMS is open to interactively 

meeting with the sponsor -- and we encourage that meeting to include the 

FDA as well -- to review the data as it’s complied so that we can, you know, 

weigh in early as the data is accumulated and provide feedback when CMS 

would be open to considering that data to be enough and sufficient to cover 

that study if it were to be submitted to CMS as a category B device.

And I would say of the ones that have transitioned, you know, we have 

definitely entertained an interactive approach to that review. The idea is to...

((Crosstalk)) 

(Chandra Branham): Can you say anything about...

Daniel Canos: The idea is to streamline the process so that you’re not going to FDA for 

categorization only for CMS to turn it down if it were to come across our 

desk. So I think I really encourage an interactive process in that.
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 22

(Chandra Branham): Thank you. Can you say anything about the number of those that have 

transitioned? I mean, is it...

((Crosstalk))

Daniel Canos: That I can’t. 

((Crosstalk))

Daniel Canos: Yes. That exact number, I do not have. 

(Chandra Branham): Okay. Thank you. 

Coordinator: We do have another question. (Brooke Laughlin) your line is open. 

(Brooke Laughlin): Hi. Yes, we were just calling to wonder if changes are made to the 

protocol because there’s an iteration in the device, does that require a new 

CMS application? Or what changes kind of constitute requiring a renewal of 

the CMS application? 

Daniel Canos: Also another good question. So we really don’t require submission of a new 

protocol for review unless it substantially affects the conduct of the study and, 

you know, ability to assess those primary endpoints. So we are open to 

receiving revisions to the protocol as FDA approves them and also adding that 

to the file, but we really don’t require you know, we don’t have a re-review of 

that IDE study unless the actual primary intent, primary purpose of the study, 

changes due to a protocol revision. 

(Brooke Laughlin): Okay. Thank you. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 23

Coordinator: At this time, we have no further questions. I’ll turn it back over to you, Ms. 

Aihie. 

Soma Kalb: I wanted to address our last question that we had prepared initially that we 

receive frequently. One is that if a study is designated as category A and 

initial questions of safety and effectiveness are resolved during the conduct of 

an IDE, does FDA automatically change the category or is it only by request 

of the sponsor? 

Ken Skodacek: That’s a good question. So yes, everything has to come in through a 

supplement to us. So we don’t monitor the connection between all the various 

IDE supplements we get, right? So Daniel mentioned that they only want to 

see major changes in the protocol. But we see a lot of different IDE 

supplements for changes in the protocol, changes in the device, changes in 

manufacturing, changes in the status of the study -- maybe they’ve completed 

enrollment -- but we don’t necessarily tie those to the category.

So if you want to change the category based on data you’ve collected in the 

trial, you have to submit a supplement to make the request for that change. 

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 web page at www.fda.gov/training/cdrhlearn by 

Wednesday, January 24th. 

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

contact information provided at the end of the slide presentation. 
FDA Webinar

Moderator: Irene Aihie

01-16-18/3:00 pm ET

Page 24

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 fda.gov/cdrhwebinar 

immediately following the conclusion of today’s live webinar. 

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

Coordinator: Thank you for your participation. All parties may disconnect at this time. 

END