Document ID: FDA-2016-D-1159-0006
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid
Services With Coverage Decisions; Guidance for Sponsors, Clinical
Investigators, Industry, Institutional Review Boards, and Food and Drug
Administration Staff; Availability
Posted Date: 2017-12-05T05:00Z

[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Notices]
[Pages 57460-57462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1159]

Food and Drug Administration Categorization of Investigational 
Device Exemption Devices To Assist the Centers for Medicare and 
Medicaid Services With Coverage Decisions; Guidance for Sponsors, 
Clinical Investigators, Industry, Institutional Review Boards, and Food 
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``FDA Categorization of 
Investigational Device Exemption (IDE) Devices to Assist the Centers 
for Medicare and Medicaid Services (CMS) with Coverage Decisions; 
Guidance for Sponsors, Clinical Investigators, Industry, Institutional 
Review Boards, and Food and Drug Administration Staff.'' This guidance 
modifies the FDA's current policy on categorization of investigational 
device exemption (IDE) devices, which assists the CMS in determining 
whether or not an IDE device should be covered (reimbursed) by CMS. On 
December 2, 2015, FDA's Center for Devices and Radiological Health 
(CDRH) and CMS's Coverage and Analysis Group (CAG) executed a 
Memorandum of Understanding (MOU) to streamline and facilitate the 
efficient categorization of investigational medical devices in order to 
support CMS's ability to make Medicare coverage (reimbursement) 
determinations for those devices. This guidance document further 
explains the framework that FDA intends to follow for such 
categorization decisions.

DATES: The announcement of the guidance is published in the Federal 
Register on December 5, 2017.

ADDRESSES: You may submit either electronic or written comments on this 
guidance at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1159 for ``FDA Categorization of Investigational Device 
Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid 
Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical 
Investigators, Industry, Institutional Review Boards, and Food and Drug 
Administration Staff.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff office between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the

[[Page 57461]]

electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled ``FDA 
Categorization of Investigational Device Exemption (IDE) Devices to 
Assist the Centers for Medicare and Medicaid Services (CMS) with 
Coverage Decisions; Guidance for Sponsors, Clinical Investigators, 
Industry, Institutional Review Boards, and Food and Drug Administration 
Staff'' to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002; or the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Owen Faris, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1682, Silver Spring, MD 20993-0002, 301-796-6356, 
or Stephen Ripley, Center for Biologics Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for sponsors, 
clinical investigators, industry, institutional review boards, and FDA 
staff entitled, ``FDA Categorization of Investigational Device 
Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid 
Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical 
Investigators, Industry, Institutional Review Boards, and Food and Drug 
Administration Staff.'' This guidance modifies the FDA's current policy 
on categorization of IDE devices. In September 1995, FDA entered into 
an Interagency Agreement (IA) regarding reimbursement categorization of 
investigational devices with the Health Care Financing Administration 
(now known as CMS). FDA would assign a device with an approved IDE 
based on the level of risk the device presented to patients. The 
categorization would then be used by CMS as part of its determination 
of whether or not items and services met the requirements for Medicare 
coverage under section 1862(a)(1)(A) of the Social Security Act. In 
following with the IA, FDA categorized devices as either Category A 
(``Experimental'') or Category B (``Nonexperimental/Investigational''). 
In the more than 20 years since the IA was signed, FDA has received a 
number of IDEs which do not easily fit into any of the eight sub-
categories identified in the IA. There have also been several 
developments which prompted FDA and CMS to revise their shared 
understanding regarding the categorization of IDE devices. These 
include the publication of the guidance document entitled, 
``Investigational Device Exemptions (IDEs) for Early Feasibility 
Medical Device Clinical Studies, Including Certain First in Human (FIH) 
Studies; Guidance for Industry and Food and Drug Administration 
Staff,'' (Ref. 1) and a subsequent increase in submission of early 
feasibility studies to FDA, as well as modifications to CMS's 
regulation regarding IDEs (42 CFR 405 Subpart B).
    On December 2, 2015, FDA's CDRH and CMS's Coverage and Analysis 
Group (CAG) executed a Memorandum of Understanding (MOU) to streamline 
and facilitate the efficient categorization of investigational medical 
devices. The MOU became effective as of June 2, 2016. This guidance 
document describes the process and information that will be used to 
help determine the appropriate category for a device to be studied. 
Importantly, the categorization paradigm has shifted from a more rigid 
approach to one which allows more flexibility and could be of great 
benefit specifically to manufacturers of, and patients receiving, 
innovative medical devices. The previous categorization paradigm 
included several specific criteria upon which a categorization would be 
based. These criteria were tied to information known about other 
similar, legally marketed products. The policy has been revised in 
order to allow FDA to consider information known about investigational 
devices as well, and provide FDA the flexibility to change 
categorization as more information regarding a device has been 
obtained. Therefore, while an innovative medical device may not be 
reimbursable during early-stage clinical trials, information gained 
during such studies now can be utilized to potentially help support a 
category change, and thus full reimbursement, for the device during 
subsequent studies.
    FDA considered comments received on the draft guidance that 
appeared in the June 1, 2016, Federal Register notice (81 FR 35032). 
FDA revised the guidance as appropriate in response to the comments. 
This document supersedes IDE Guidance Memorandum #95-2 ``Implementation 
of the FDA/HCFA Interagency Agreement Regarding Reimbursement 
Categorization of Investigational Devices'' issued on September 15, 
1995.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``FDA Categorization of Investigational 
Device Exemption (IDE) Devices to Assist the Centers for Medicare and 
Medicaid Services (CMS) with Coverage Decisions.'' It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. A search capability for all CBER guidance documents is 
available at: https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents 
are also available at https://www.regulations.gov. Persons unable to 
download an electronic copy of ``FDA Categorization of Investigational 
Device Exemption (IDE) Devices to Assist the Centers for Medicare and 
Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, 
Clinical Investigators, Industry, Institutional Review Boards, and Food 
and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please

[[Page 57462]]

use the document number 1500074 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA and CMS regulations. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 812 have been 
approved under OMB control number 0910-0078. The collections of 
information in 42 CFR part 405, subpart B have been approved under OMB 
control number 0938-1250.

V. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.
    1. Investigational Device Exemptions (IDEs) for Early Feasibility 
Medical Device Clinical Studies, Including Certain First in Human (FIH) 
Studies; Guidance for Industry and Food and Drug Administration Staff, 
available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.

    Dated: November 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26195 Filed 12-4-17; 8:45 am]
 BILLING CODE 4164-01-P