Welcome to today’s

FDA/CDRH Webinar

Thank you for your patience while we register all 

of today’s participants. 

If you have not connected to the audio portion of the 

webinar, please do so now:

U.S Callers: 877-917-9491

International Callers: 1-212-287-1619

Passcode: PW1052941 1 
“FDA Categorization of Investigational Device Exemption 

(IDE) Devices to Assist the Centers for Medicare and Medicaid 

Services (CMS) with Coverage Decisions”

Carla M. Wiese

Policy Analyst for the Early Feasibility Program

Office of Device Evaluation

Center for Devices and Radiological Health 2 

New FDA Draft Guidance
Agenda

• 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

• Considerations when changing from Category A 

to B

• How a category designation may affect coverage 

in a study

• Other factors that may impact coverage 3 
Why Are IDE Studies Conducted?

An investigational device exemption (IDE) 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 FDA has 

determined: 

 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 IRB approval.

 Benefit-risk profile for the study is favorable.

4 Reference: 21 CFR 812
Generally, an IDE study is conducted to answer 

outstanding questions about safety and effectiveness.

However, the extent to which initial questions of 

safety and effectiveness are already addressed depends 

on many factors.

5 

Why Are IDE studies Conducted?

Continued...
Why IDEs Are Categorized

 An Interagency Agreement (IA) between CMS 

and the FDA was made in 1995 to support CMS’ 

decision making for coverage. As part of this 

agreement, FDA assigns a device with an FDA 

approved IDE to one of two categories: 

– Experimental/Investigational (Category A) 

– Non-experimental/Investigational (Category B)

 This agreement allowed for expanded coverage 

to include some investigational devices.

6 
Why IDEs Are Categorized

The 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 IA 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. 7 
Why There is New Guidance 

Related to CMS Categorization

1) The previous FDA policy regarding 

categorization did not adequately articulate 

criteria that are relevant to certain studies 

such as feasibility studies.

2) The previous policy did not contain sufficient 

guidance regarding how a category designation 

may change from A to B.

3) The previous criteria did not consider all 

regulatory pathways. (e.g. de novo submission)

8 
Additional Factors

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. 

9 
1995 Interagency Agreement Draft Guidance

Detailed criteria were used to designate

an IDE device category.

Criteria have been simplified to ensure that 

devices fall into the correct category.

Limited or no visibility to how a 

category change may occur as 

knowledge is gained.

Draft guidance provides an explanation of 

how a category change may occur.

No examples provided. Examples provided.

FDA review team makes the category 

designation.

Unchanged

Category designation is to be based on 

the degree to which initial questions of 

safety and effectiveness are resolved.

Unchanged

The categorization will then be used by 

CMS as part of its determination of 

whether or not items and services will 

be covered. 

Unchanged

10

Changes The same
Draft Guidance

Draft guidance is proposed documentation not yet 

ready for implementation.

Issuance Date: June 1, 2016

Comment period closes: August 1, 2016

www.regulations.gov 

docket # FDA-2016-D-1159 

11
Regulatory Context: 

Category A

Category A: Experimental 

42 CFR 405.201(b): 

“...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.”

12
Proposed Criteria:

Category A

FDA intends to consider a device to be in Category A if 

one or more of the following criteria are met:

1. No PMA approval, 510(k) 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. 

13
2. The proposed device has different 

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 non-clinical 

and/or clinical data on the proposed device 

also do not resolve these questions. 

14

Proposed Criteria:

Category A
3. The proposed device is being studied for a 

new indication or new intended use for 

which information from the proposed or 

similar device related to the previous 

indication does not resolve initial questions 

of safety and effectiveness. Available nonclinical and/or clinical data on the proposed 

device relative to the new indication or 

intended use also do not resolve these 

questions. 15

Proposed Criteria: 

Category A
A device 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 potential 

device design or procedural improvements. 

16

Category A Example
An already approved or cleared 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 safely placed in the new 

anatomical location and whether the device can also be 

effective in the new anatomical location. Therefore, 

there are inadequate data to resolve the initial 

questions of safety and effectiveness relative to the 

new intended use or indication. 17

Category A Example
Category B: Nonexperimental/Investigational 

42 CFR 405.201(b)

“...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.” 

18

Regulatory Context:

Category B
Proposed Criteria: 

Category B

FDA intends to consider a device to be in Category B if one 

or more of the following criteria are met:

1. No PMA approval, 510(k) clearance or de novo request 

has been granted for the proposed device or similar 

devices; however, available clinical data (e.g., 

feasibility study data) and/or non-clinical data for the 

proposed device or a similar device resolve the initial 

questions of safety and effectiveness. 

19
2. 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. 20

Proposed Criteria:

Category B
3. The proposed device 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 nonclinical and/or clinical data on the proposed 

device may have been used in conjunction 

with the leveraged information to resolve 

these questions. 21

Proposed Criteria:

Category B
Adequate data have been gathered from nonclinical 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. 

22

Category B Example
An approved device will be evaluated for a new 

indication. 

Data exist on the approved device for another 

similar indication, and non-clinical data have 

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. 

23

Category B Example
When Are IDEs Categorized?

The FDA review team will make a categorization 

decision at the time of the first approval (full or 

conditional) of an IDE study. 

A categorization change will be considered for study 

expansion or upon a request for re-designation.

The category is included in FDA’s approval letter for 

the IDE.

24
Information That May Support 

a Category Change

• Nonclinical test data

• External data on the technology (e.g. data from other 

similar devices)

• Preliminary clinical data on the device

25
Example of a Change From 

Category A to B

Adequate data have been gathered on a device from 

non-clinical testing, the completion of an early 

feasibility study within the United States (US), as well 

as a small non-US 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 have since been gathered to support a change to 

Category B for the traditional feasibility study. 26
How a Categorization Designation 

May Affect Coverage in a Study

• If the study is designated Category A: the 

device may not be covered but routine care 

and services may be covered.

• If the study is designated Category B: then 

the device and routine care and services may 

be covered.

27
Other Factors That May Affect 

Coverage in a Study

• Has a previous national coverage decision been 

made for the device type and/or procedure?

 A coverage decision may supersede the category designation.

• Will the device be adjunctive to a procedure in 

which a coverage decision has been made?

 A coverage decision may supersede the category designation.

• Is the device relevant to the Medicare population?

• Have other CMS criteria been met (reference the 

CMS website link at the end of this presentation)?

• Others... 28
Links

Link to the FDA Draft Guidance

“FDA Categorization of Investigational Device Exemption (IDE) 

Devices to Assist the Centers for Medicare and Medicaid Services 

(CMS) with Coverage Decisions” 

• http://www.fda.gov/downloads/MedicalDevices/DeviceRegulatio

nandGuidance/GuidanceDocuments/ucm504091.pdf

Link to a CMS website 

“Medicare Coverage Related to Investigational Device Exemption 

(IDE) Studies”

• https://www.cms.gov/medicare/coverage/IDE/index.html

29
Questions? 

Contact CDRH's Division of Industry and Consumer Education 

(DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-

7100 

Slide Presentation, Transcript and Webinar Recording will be 

available at:

http://www.fda.gov/training/cdrhlearn

Under “How to Study and Market Your Device” Heading

30