Document ID: FDA-2017-D-6154-0011
Agency: fda
Document Type: Notice
Title: Evaluation of Devices Used With Regenerative Medicine Advanced
Therapies; Guidance for Industry; Availability
Posted Date: 2019-02-19T05:00Z

[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4821-4823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6154]

Evaluation of Devices Used With Regenerative Medicine Advanced 
Therapies; Guidance for Industry; 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 a final guidance entitled ``Evaluation of Devices 
Used with Regenerative Medicine Advanced Therapies; Guidance for 
Industry.'' The guidance document provides manufacturers, applicants, 
and sponsors engaged in the development of regenerative medicine 
therapies, with our current thinking regarding evaluation of devices 
used in the recovery, isolation or delivery of regenerative advanced 
therapies, which FDA generally refers to as ``regenerative medicine 
advanced therapies'' or ``RMATs.'' Specifically, the guidance addresses 
how FDA intends to simplify and streamline its application of 
regulatory requirements for combination device and cell or tissue 
products; what, if any, intended uses or specific attributes would 
result in a device used

[[Page 4822]]

with a regenerative therapy product to be classified as a class III 
device; the factors to consider in determining whether a device may be 
labeled for use with a specific RMAT or class of RMATs; when a device 
may be limited to a specific intended use with only one particular type 
of cell; and application of the least burdensome approach to 
demonstrate how a device may be used with more than one cell type. The 
issuance of this guidance fulfills the statutory requirement set forth 
in a certain section of the 21st Century Cures Act (Cures Act). The 
guidance announced in this notice finalizes the draft guidance of the 
same title dated November 2017.

DATES: The announcement of the guidance is published in the Federal 
Register on February 19, 2019.

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 identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-6154 for ``Evaluation of Devices Used with Regenerative 
Medicine Advanced Therapies; Guidance for Industry.'' 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/2015-23389.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)).
    Submit written requests for single copies of the guidance to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), 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 the office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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 document entitled 
``Evaluation of Devices Used with Regenerative Medicine Advanced 
Therapies; Guidance for Industry.'' The guidance provides 
manufacturers, applicants and sponsors engaged in the development of 
regenerative medicine therapies, with our current thinking regarding 
evaluation of devices used in the recovery, isolation or delivery of 
regenerative advanced therapies, which FDA generally refers to as 
``RMATs.'' Specifically, the guidance addresses how FDA intends to 
simplify and streamline its application of regulatory requirements for 
combination device and cell or tissue products; what, if any, intended 
uses or specific attributes would result in a device used with a 
regenerative therapy product to be classified as a class III device; 
the factors to consider in determining whether a device may be labeled 
for use with a specific RMAT or class of RMATs; when a device may be 
limited to a specific intended use with only one particular type of 
cell; and application of the least burdensome approach to demonstrate 
how a device may be used with more than one cell type.
    The issuance of the final guidance fulfills the statutory 
requirement set forth in section 3034(b) of the Cures Act (Pub. L. 114-
255) and sets forth information about a wide range of concepts related 
to the regulation of devices used in the recovery, isolation, and 
delivery of RMATs. As our experience with these products grows, we may 
consider issuing guidance on more specific topics related to these

[[Page 4823]]

devices to provide additional recommendations to stakeholders.
    In the Federal Register of November 17, 2017 (82 FR 54349), FDA 
announced the availability of the draft guidance of the same title 
dated November 2017. FDA considered comments received on the draft 
guidance. FDA revised the guidance as appropriate in response to the 
comments and made editorial changes to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated November 
2017.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a document entitled ``Expedited Programs for 
Regenerative Medicine Therapies for Serious Conditions; Guidance for 
Industry.''
    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 ``Evaluation of Devices Used with 
Regenerative Medicine Advanced Therapies.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA 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 807 have been approved under 
OMB control number 0910-0120; the collections of information in 21 CFR 
part 812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 814 have been approved under 
OMB control numbers 0910-0231 and 0910-0332; the collections of 
information in 21 CFR part 1271 have been approved under OMB control 
number 0910-0543; and the collections of information in the guidance 
document ``De Novo Classification Process (Evaluation of Automatic 
Class III Designation)'' have been approved under OMB control number 
0910-0844.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: February 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02692 Filed 2-15-19; 8:45 am]
 BILLING CODE 4164-01-P