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, 57460-57462 [2017-26195]

Download as PDF 57460 Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices SUMMARY OF BURDEN ESTIMATES Number of respondents Respondent/data collection activity Minutes per response Annual burden hours Resource Support Requests ..................................................... Legal Training, Case Consultation, Technical Assistance Requests. Outcome Measurement ............................................................ 80 14,000 1 min 54 sec ........................... 1 min 42 sec ........................... 2.53 hours. 397 hours. 3,500 1 min 3 sec ............................. 61.25 hours. Total ................................................................................... 17,580 4 min 39 sec ........................... 460.78 hours. Dated: November 24, 2017. Mary Lazare, Principal Deputy Administrator. 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: [FR Doc. 2017–26116 Filed 12–4–17; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions 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. 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 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:13 Dec 04, 2017 Jkt 244001 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.’’ PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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/201523389.pdf. Docket: For access to the docket to read background documents or the E:\FR\FM\05DEN1.SGM 05DEN1 Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 18:13 Dec 04, 2017 Jkt 244001 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 57461 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/ GuidanceComplianceRegulatory Information/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 CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please E:\FR\FM\05DEN1.SGM 05DEN1 57462 Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices 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/deviceregulation andguidance/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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1210] sradovich on DSK3GMQ082PROD with NOTICES Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ‘‘Technical Considerations for Additive SUMMARY: VerDate Sep<11>2014 18:13 Dec 04, 2017 Jkt 244001 Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.’’ FDA has developed this leapfrog guidance to provide FDA’s initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. This guidance outlines technical considerations associated with additive manufacturing processes as well as testing and characterization for final finished devices fabricated using additive manufacturing. 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 Agency guidances 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–D–1210 for ‘‘Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability.’’ 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 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/201523389.pdf. Docket: For access to the docket to read background documents or the 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download E:\FR\FM\05DEN1.SGM 05DEN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 CDRH-Guidance@fda.hhs.gov 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