[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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guidance announced in this notice finalizes the draft guidance of the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