Notice2021-18912
Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care To Produce a Therapeutic Article
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Published
September 13, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is consolidating regulatory oversight responsibilities in the Center for Biologics Evaluation and Research (CBER) for certain devices that process autologous human cells, tissues, and cellular and tissue-based products (HCT/Ps) at the point of care where the device output is intended to mediate the intended therapeutic effect. To support this consolidation effort, fat transfer devices (described further below) with the product code MUU that are currently regulated by the Center for Devices and Radiological Health (CDRH) will be transferred to CBER for regulation. This action affects only center assignment.
Full Text
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<title>Federal Register, Volume 86 Issue 174 (Monday, September 13, 2021)</title>
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[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Page 50887]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18912]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0881]
Consolidation of Devices That Process Autologous Human Cells,
Tissues, and Cellular and Tissue-Based Products at the Point of Care To
Produce a Therapeutic Article
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
consolidating regulatory oversight responsibilities in the Center for
Biologics Evaluation and Research (CBER) for certain devices that
process autologous human cells, tissues, and cellular and tissue-based
products (HCT/Ps) at the point of care where the device output is
intended to mediate the intended therapeutic effect. To support this
consolidation effort, fat transfer devices (described further below)
with the product code MUU that are currently regulated by the Center
for Devices and Radiological Health (CDRH) will be transferred to CBER
for regulation. This action affects only center assignment.
FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5130, Silver Spring, MD 20993, 301-796-8941,
<a href="/cdn-cgi/l/email-protection#0d67626563237a686463687f4d6b696c2365657e236a627b"><span class="__cf_email__" data-cfemail="b8d2d7d0d696cfddd1d6ddcaf8dedcd996d0d0cb96dfd7ce">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Consolidation in CBER of Devices That Process Autologous Human
Cells, Tissues, and Cellular and Tissue-Based Products at the Point of
Care To Produce a Therapeutic Article
FDA is consolidating regulatory oversight responsibilities in CBER
for devices that process autologous human cells, tissues, and cellular
and tissue-based products (HCT/Ps) at the point of care to produce a
therapeutic article. To support this consolidation effort, fat transfer
devices (described further below) with the product code MUU that are
currently regulated by CDRH will be transferred to CBER for regulation.
This action affects only center assignment.
FDA has the authority to regulate devices as defined under section
201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).
Devices may be regulated by CDRH or CBER (see, e.g., Ref.1).
In July 2007, the Agency published the final guidance ``Devices
Used to Process Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)'' to assist sponsors in determining which center at
FDA would have regulatory oversight for devices used at the point of
care to process HCT/Ps (Ref. 2). Assignment of these devices is
determined by whether the point-of-care device creates an HCT/P that is
intended to mediate the intended therapeutic effect. Point-of-care
devices that process autologous materials are assigned to CBER when the
intended therapeutic effect is mediated by the biological output of the
device. For example, a cell sorter that is used to isolate CD34+ cells
from bone marrow for use in hematopoietic reconstitution is assigned to
CBER for review and regulation because the cellular output of the
device is intended to provide the intended therapeutic effect.
Since the publication of the 2007 guidance, assignment of point-of-
care devices intended to process HCT/Ps has generally been consistent
with that guidance, with a few exceptions. Under 21 CFR 878.5040, a
suction lipoplasty system is a Class II device that is intended for
aesthetic body contouring and consists of a powered suction pump
(containing a microbial filter on the exhaust and a microbial in-line
filter in the connecting tubing between the collection bottle and the
safety trap), collection bottle, cannula, and connecting tube. These
devices act by removal of unwanted fat from areas of the body.
However, fat transfer devices, that is, devices that process
adipose tissue for return to the body, have also been regulated at CDRH
and assigned the same product code, MUU, as suction lipoplasty systems.
While suction lipoplasty devices for fat removal do not produce an
article for return to the body in order to mediate an intended
therapeutic effect, the output of fat transfer devices is returned to
the body in order to mediate the intended therapeutic effect (e.g.,
administration of fat for the purpose of body contouring). Accordingly,
we are transferring fat transfer devices identified by product code MUU
to CBER so that these devices are regulated by the same center that
regulates other devices that process HCT/Ps where the device output
(HCT/P) mediates the intended therapeutic effect.
This transfer does not include the suction lipoplasty devices
previously in product code MUU that are solely intended to remove fat
for discard for the purpose of body contouring. These devices have been
assigned a new product code, QPB, and will continue to be regulated by
CDRH. For the transferred MUU products, submissions, communications,
and required reports should be directed to CBER. Submissions,
communications, and required reports for the QPB products should
continue to be directed to CDRH. Additionally, CDRH will continue to
handle submissions under review or on hold (i.e., received prior to the
publication date of this Federal Register document) for MUU products
until a final decision is reached. Subsequent submissions for MUU
products will be directed to CBER.
II. Reference
The following references are on display in the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. SMG (FDA Staff Manual Guides) 1410.406, ``Determination of
Classification of Devices,'' November 13, 2018. <a href="https://www.fda.gov/media/80114/download">https://www.fda.gov/media/80114/download</a>.
2. ``Guidance for industry and FDA staff Devices Used to Process
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps),'' July 2007. <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/devices-used-process-human-cells-tissues-and-cellular-and-tissue-based-products-hctps">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/devices-used-process-human-cells-tissues-and-cellular-and-tissue-based-products-hctps</a>.
Authority: 21 U.S.C. 321(h).
Dated: August 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18912 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P
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