Document ID: FDA-2017-D-6154-0001
Agency: fda
Document Type: Notice
Title: Evaluation of Devices Used With Regenerative Medicine Advanced 
Therapies; Draft Guidance for Industry; Availability
Posted Date: 2017-11-17T05:00Z

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54349-54351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24836]

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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Therapies; Draft Guidance for Industry; Availability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 draft document entitled ``Evaluation of Devices 
Used with Regenerative Medicine Advanced Therapies; Draft Guidance for 
Industry.'' The draft guidance document, when finalized, will provide 
device 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, as required by the 21st Century Cures Act 
(Cures Act),

[[Page 54350]]

the draft guidance addresses how FDA intends to simplify and streamline 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; 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.

DATES: Submit either electronic or written comments on the draft 
guidance by February 15, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments 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; Draft 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 draft 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 draft 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 draft 
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 draft document entitled 
``Evaluation of Devices Used with Regenerative Medicine Advanced 
Therapies; Draft Guidance for Industry.'' The draft guidance, when 
finalized, will provide device 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, as required by section 3034 of the 21st 
Century Cures Act (Pub. L. 114-255) (Cures Act), the draft 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; 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 draft guidance fulfills the statutory 
requirement set forth in section 3034(a) of the Cures Act. Furthermore, 
the Agency intends for this document, when finalized, to serve as a 
source of information about the Agency's current thinking about a wide 
range of concepts related to the regulation of devices, as they apply 
to devices used in the recovery, isolation, and delivery of RMATs. FDA 
has provided general information in the

[[Page 54351]]

draft guidance in lieu of specific examples because the Agency does not 
yet possess a wide body of experience regarding the evaluation of 
devices used with RMATs, given the recent establishment of the RMAT 
designation program in the Cures Act.
    As we gain more experience with such devices, we intend to 
incorporate such information into the final guidance. To that end, 
although you are welcome to comment on any aspect of the guidance, we 
encourage commenters to support their comments with information related 
to specific marketed devices or types of devices that are used in the 
recovery, isolation, and delivery of RMATs.
    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; Draft Guidance 
for Industry.'' Among other things, that document provides information 
about the RMAT designation program.
    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 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 draft 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 number 0910-0231; and the collections of information in 21 
CFR part 1271 have been approved under OMB control number 0910-0543.

III. Electronic Access

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

    Dated: November 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24836 Filed 11-16-17; 8:45 am]
 BILLING CODE 4164-01-P