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FDA Categorization of Investigational Device 

Exemption (IDE) Devices to Assist the

Centers for Medicare and Medicaid Services 

(CMS) with Coverage Decisions Final 

Guidance

Ken Skodacek

Policy Analyst

Clinical Trials Program & 

Payer Communication Task Force

Office of Device Evaluation

Center for Devices and Radiological Health
3 

 • Investigational Device Exemption (IDE)

 • Background and Rationale

 • FDA Process: Category Criteria & Examples

 • CMS Process: Application & Criteria

• Changing the Category

• References, Questions & Answers
4 

IDE Clinical Investigations 

• Approved investigational device exemption (IDE) allows device to be 

used in a clinical study in order to collect safety and effectiveness 

data.

• Generally, an 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.

21 CFR Part 812
5 

IDE Decision-Making Process

Approval of an IDE application indicates FDA has 

determined:

• Sponsor has provided adequate data to support initiation 

of the study.

• No subject protection concerns to preclude initiation of the 

study after Institutional Review Board (IRB) approval.

• Benefit-risk profile for the study is favorable.

FDA’s process and considerations outlined in guidance:

• FDA Decisions for Investigational Device Exemption 

Clinical Investigations

• Factors to Consider When Making Benefit-Risk 

Determinations for Medical Device Investigational Device 

Exemptions
6 

 • Investigational Device Exemption (IDE)

 • Background and Rationale

 • FDA Process: Category Criteria & Examples

• CMS Process: Application & Criteria

• Changing the Category

• References, Questions & Answers
7 

Background: “CMS Category”

To support the Centers for Medicare and Medicaid Services (CMS), FDA 

categorizes IDE devices based on whether available data demonstrates that initial 

questions of safety and effectiveness have been resolved.

IDE applications are assigned to one of two categories:

• Category A - Experimental devices

• Category B - Non Experimental/Investigational devices

FDA communicates this categorization in our regulatory decision letters by 

assigning a “CMS Category.” CMS uses this categorization as one of several 

factors in its determination of which devices meet the requirements for Medicare 

coverage.
8 

Historical Context

1995

FDA & Health 

Care 

Financing 

Administration

(now known 

as CMS) 

Interagency 

Agreement

2017

FDA 

Categorization 

Guidance

FDA & CMS 

Memorandum 

of 

Understanding 

(Jun 2010)

2010

FDA & CMS 

Memorandum of 

Understanding 

(Dec 2015)

2015

Change in 

Medicare 

Coverage 

for IDE’s 

(Jan 2015)
9 

Primary Rationale for Guidance

• Previous FDA policy regarding categorization did 

not adequately articulate criteria that are relevant 

to certain studies such as feasibility studies.

• Previous criteria did not consider all regulatory 

pathways (e.g., De Novo request).

• Previous policy did not contain sufficient 

guidance regarding how a category designation 

may change from A to B.
10

Secondary Rationale for Guidance

• CMS changed from local Medicare 

Administrative Contractor (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.
11

Compare and Contrast

1995 Interagency Agreement FDA Categorization 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

Same (no changes) Changes 

1995 Interagency Agreement FDA Categorization 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.

Final 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

Categorization will then be used by 

CMS as part of its determination of 

whether or not items and services will 

be covered.

Unchanged
12

 • Investigational Device Exemption (IDE)

 • Background and Rationale

 • FDA Process: Category Criteria & Examples

• CMS Process: Application & Criteria

• Changing the Category

• References, Questions & Answers
13

IDE Review by FDA: Categorization

• IDE application

• FDA review

• Category assigned in 

IDE approval letter

Step 1:

FDA 

Process
14

Category A: Regulatory Context

Experimental

“...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.”

42 CFR 405.201(b)
15

Category A: 1st Criterion 

An IDE is assigned Category A 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, 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.”

• No prior approved/cleared device

• Available data do not resolve initial questions of 

safety and effectiveness
16

Category A: 2nd Criterion 

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

criteria are met:

“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 

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

effective.”

• New indication or new intended use

• Available data do not resolve initial questions of 

safety and effectiveness
17

Category A: 3rd Criterion 

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

criteria are met:

“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 non-clinical and/or 

clinical 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.”

• New technological characteristics compared to 

approved/cleared devices

• Available data do not resolve initial questions of 

safety and effectiveness
18

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

three criteria are met:

Category A: Summary of Criteria

• No prior approved/cleared device

• Available data do not resolve initial questions of safety 

and effectiveness

• New indication or new intended use

• Available data do not resolve initial questions of safety 

and effectiveness

• New technological characteristics compared to 

approved/cleared devices

• Available data do not resolve initial questions of safety 

and effectiveness
19

Category A: Examples

• Novel device with no or limited previous human 

use

– Remaining initial questions of safety and 

effectiveness.

– Adequate non-clinical information to support initiation 

of an early feasibility study.

• New device

– Initial question of safety have been answered with 

non-clinical data and short-term clinical data.

– Additional data needed to resolve initial questions of 

effectiveness. 
20

Category B: Regulatory Context

42 CFR 405.201(b)

Nonexperimental/Investigational

“...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.”
21

Category B: 1st Criterion 

An IDE is assigned 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 

information (e.g., feasibility study data) from the proposed device or a 

similar device resolves the initial questions of safety and 

effectiveness.”

• No prior approved/cleared device

• However, available data resolves initial questions of 

safety and effectiveness
22

Category B: 2nd Criterion

An IDE is assigned Category B if one or more of the following 

criteria are met:

“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.”

• New indication or new intended use

• However, available data resolves initial questions of 

safety and effectiveness
23

Category B: 3rd Criterion

An IDE is assigned Category B if one or more of the following 

criteria are met:

“The proposed device has similar technological 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. In some cases, additional nonclinical and/or clinical data on the proposed device may also have 

been used to resolve these questions.”

• Similar technological characteristics compared to 

approved/cleared devices

• Available data resolves initial questions of safety and 

effectiveness
24

Category B: Summary of Criteria

• No prior approved/cleared device

• However, available data resolves initial questions of

safety and effectiveness

• New indication or new intended use

• However, available data resolves initial questions of

safety and effectiveness

• Similar technological characteristics compared to

approved/cleared devices

• Available data resolves initial questions of safety and

effectiveness

An IDE is assigned Category B if one or more of the following 

three criteria are met:
25

Category B: Examples

• Device similar to other devices on the market

– Substantial safety and effectiveness information exists 

from other similar devices of the same type that are 

used for a similar indication.

– Clinical information from similar devices and non-clinical 

test data for the new device answer initial safety and 

effectiveness questions.

• Approved device for a new indication

– Data exist on the approved device for a similar 

indication.

– Non-clinical data also provided to answer initial 

questions of safety and effectiveness.
26

 • Investigational Device Exemption (IDE)

 • Background and Rationale

• FDA Process: Category Criteria & Examples

 • CMS Process: Application & Criteria

• Changing the Category

• References, Questions & Answers
27

IDE Review by CMS: Decision

• IDE coverage application

• CMS review

• Covered studies posted 

to Approved IDE Studies

Step 2:

CMS 

Process

Medicare Coverage Related to Investigational Device 

Exemption (IDE) Studies 
28

IDE Review: Two Step Process

• IDE application

• FDA review

• Category assigned in 

IDE approval letter

Step 1:

FDA 

Process

• IDE coverage application

• CMS review

• Covered studies posted 

to Approved IDE Studies

Step 2:

CMS 

Process
29

CMS Coverage: Result

Category A (Experimental) IDE

• Approval by CMS will allow coverage of routine care items and 

services furnished in the study, but not of the Category A device, which 

is statutorily excluded from coverage.

Category B (Nonexperimental/investigational) IDE

• Approval by CMS will allow coverage of the Category B device and the 

routine care items and services in the trial.
30

 • Investigational Device Exemption (IDE)

 • Background and Rationale

 • FDA Process: Category Criteria & Examples

• CMS Process: Application & Criteria

• Changing the Category

• References, Questions & Answers
31

Changing Category: Rationale

• Clinical and/or non-clinical data gathered during 

the study may resolve initial questions of safety 

and effectiveness.

• Category A study is completed resolving the initial 

questions of safety and effectiveness.
32

Changing Category: Data

Examples of data that may support a change from Category A 

to Category B can include but are not limited to: 

• Peer-reviewed studies on the same or a similar device

• Premarket or postmarket data from studies conducted 

outside the U.S. on the same or a similar device

• Reference to commercialization of a device of a similar 

type

• Preliminary clinical data on the device (e.g., initial data 

from a staged study, feasibility study)

• Additional non-clinical data on the same or a similar device 

may be included as supportive information
33

Changing Category: Select Examples

• Approved device with novel procedure

– Initial unresolved questions of safety and effectiveness 

regarding the novel procedure

– Remaining questions may be answered with a limited 

number of subjects as part of a larger study

• Category A device being evaluated in a study

– Clinical data for similar devices become available which 

resolve initial questions of safety and effectiveness
34

 • Investigational Device Exemption (IDE)

 • Background and Rationale

 • FDA Process: Category Criteria & Examples

• CMS Process: Application & Criteria

• Changing the Category

• References, Questions & Answers
35

Payer Communication Task Force

• Facilitates early communications between device manufacturers, payers, and 

healthcare technology assessment organizations to potentially shorten the time 

between FDA approval or clearance and actual coverage decisions

• Focus on coverage outside of IDE studies

• Coordinates FDA/CMS Parallel Review program

• Coordinates other opportunities for public and private payer engagement

Contact us at:

CDRHPayerCommunications@fda.hhs.gov

Parallel-Review@fda.hhs.gov 
36

References – Page 1

• FDA Categorization of Investigational Device Exemption (IDE) Devices to 

Assist the Centers for Medicare and Medicaid Services (CMS) with 

Coverage Decisions

• Medicare Coverage Related to Investigational Device Exemption (IDE) 

Studies 

• Medicare Approved IDE Studies

• Change in Medicare Coverage for IDE’s

• FDA Decisions for Investigational Device Exemption Clinical 

Investigations

• Factors to Consider When Making Benefit-Risk Determinations for 

Medical Device Investigational Device Exemptions
37

References – Page 2

• FDA/HCFA Interagency Agreement (1995)

• FDA/CMS Memorandum of Understanding (2010)

• FDA/CMS Memorandum of Understanding (2015)

• CDRH Payer Communication Task Force
Questions? 

Division of Industry and Consumer 

Education: DICE@fda.hhs.gov

Slide Presentation, Transcript and 

Webinar Recording will be available at:

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