81 FR 35032 - Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid Services With Coverage Decisions; Draft Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 105 (June 1, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.'' This guidance modifies FDA's current policy on categorization of IDE devices, which assists 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 investigational devices. The MOU noted the need for FDA and CMS to revise their shared understanding regarding categorization. This guidance document is intended to implement the MOU by further explaining the framework that FDA (both CDRH and the Center for Biologics Evaluation and Research) intends to follow for such decisions. This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Notices]
[Pages 35032-35033]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12828]



[[Page 35032]]

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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Medicaid Services With Coverage Decisions; Draft Guidance for Sponsors, 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 draft guidance entitled ``FDA Categorization of 
Investigational Device Exemption (IDE) Devices to Assist the Centers 
for Medicare and Medicaid Services (CMS) with Coverage Decisions.'' 
This guidance modifies FDA's current policy on categorization of IDE 
devices, which assists 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 
investigational devices. The MOU noted the need for FDA and CMS to 
revise their shared understanding regarding categorization. This 
guidance document is intended to implement the MOU by further 
explaining the framework that FDA (both CDRH and the Center for 
Biologics Evaluation and Research) intends to follow for such 
decisions. This draft guidance is not final nor is it in effect at this 
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 1, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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 copies of the guidance 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: Program Operations Staff, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 1522, Silver Spring, MD 20993-0002, 
301-796-5640; or Stephen Ripley, Center for Biologics Evaluation and 
Research,

[[Page 35033]]

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 draft 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.'' When finalized, this 
draft guidance would modify FDA's current policy on categorization of 
IDE devices. In September 1995, the Health Care Financing 
Administration (now known as CMS) published a final rule and entered 
into an Interagency Agreement (IA) with FDA regarding reimbursement 
categorization of investigational devices. (60 FR 48417, September 19, 
1995.) The rule at 42 CFR part 405, subpart B established that certain 
devices with an IDE approved by FDA (and certain services related to 
those devices) may be covered under Medicare, and set forth the process 
by which FDA would assist CMS in identifying such devices. FDA would 
assign a device with an FDA approved IDE to one of two categories: 
Experimental/Investigational (Category A) devices or Non-experimental/
Investigational (Category B) devices based on the level of risk the 
device presented to patients. The IA set forth criteria, agreed upon by 
CMS and FDA, which FDA would use to categorize devices. The 
categorization would then be used by CMS as part of its determination 
of whether or not devices met the requirements for Medicare coverage 
under section 1862(a)(1)(A) of the Social Security Act (42 U.S.C. 
1385y). CMS and FDA both recognized that experience in categorizing 
devices might require changes to the Interagency Agreement.
    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 
subcategories identified in the IA. There have been several 
developments, such as: 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;'' (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 part 405, subpart B), which have 
prompted FDA and CMS to revise their shared understanding regarding the 
categorization of IDE devices.
    On December 2, 2015, FDA's CDRH and CMS's CAG executed an MOU to 
streamline and facilitate the efficient categorization of 
investigational medical devices. The MOU will become effective June 2, 
2016. This guidance document is intended to implement the MOU and 
describes the criteria that FDA intends to use to help determine the 
appropriate category for a device to be studied. This guidance document 
also describes a pathway for changing the device category from Category 
A to Category B.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 16001 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it are also 
available electronically at http://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, available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.pdf.

    Dated: May 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12828 Filed 5-31-16; 8:45 am]
BILLING CODE 4164-01-P