Notice2024-31266
Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches
Primary source
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Published
December 30, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the transfer of regulatory responsibility for medical maggots and medicinal leeches to the Center for Biologics Evaluation and Research (CBER). These products are currently regulated by the Center for Devices and Radiological Health (CDRH). FDA is transferring regulatory responsibility of these products to CBER because these products are living organisms that more closely align with products regulated by CBER. This action affects only Center assignment and does not change requirements applicable to these products.
Full Text
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<title>Federal Register, Volume 89 Issue 249 (Monday, December 30, 2024)</title>
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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106521-106522]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31266]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5702]
Transfer of Regulatory Responsibility From the Center for Devices
and Radiological Health to the Center for Biologics Evaluation and
Research; Medical Maggots and Medicinal Leeches
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; announcement of transfer.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
transfer of regulatory responsibility for medical maggots and medicinal
leeches to the Center for Biologics Evaluation and Research (CBER).
These products are currently regulated by the Center for Devices and
Radiological Health (CDRH). FDA is transferring regulatory
responsibility of these products to CBER because these products are
living organisms that more closely align with products regulated by
CBER. This action affects only Center assignment and does not change
requirements applicable to these products.
DATES: FDA is transferring regulatory responsibility to CBER on
December 30, 2024.
FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Silver Spring, MD 20993, 301-796-8930,
<a href="/cdn-cgi/l/email-protection#20414e4e455454450e4d41525448414c4552604644410e4848530e474f56"><span class="__cf_email__" data-cfemail="1c7d72727968687932717d6e68747d70796e5c7a787d3274746f327b736a">[email protected]</span></a> or <a href="/cdn-cgi/l/email-protection#53303c3e313a3d32273a3c3d133537327d343c25"><span class="__cf_email__" data-cfemail="75161a18171c1b14011c1a1b351311145b121a03">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is announcing the transfer of regulatory
responsibility for medical maggots (Phaenicia sericacta (blow fly)
larvae) and medicinal leeches (Hirudo medicinalis) from CDRH to CBER.
Medical maggots (including maggots and larvae) (product code NQK) (also
referred to as maggot therapy) are harvested and provided disinfected
for use in debriding non-healing necrotic skin and soft tissue wounds,
including pressure ulcers, venous stasis ulcers, neuropathic foot
ulcers, and non-healing traumatic or post-surgical wounds. Medicinal
leeches (product code NRN) belong to the Annelida worm classification.
The animal is a bloodsucking aquatic animal living in fresh water
indicated as an adjunct to graft tissue healing when problems of venous
congestion may delay healing, or to overcome the problem of venous
congestion by creating prolonged localized bleeding.
FDA is transferring the regulatory responsibility for medical
maggots and medicinal leeches to CBER so that these products are
regulated by the same Center that regulates other living organisms for
human use. The transfer will help ensure the consistent and effective
regulation of products that are living organisms for human use. This
transfer affects only Center assignment and does not change
requirements applicable to these products.
For the transferred products, submissions, communications, and
required reports should be directed to CBER after December 30, 2024.
CDRH will continue to handle submissions
[[Page 106522]]
received (including those under review or on hold) until the
publication date of this Federal Register document for transferred
products and, if applicable, until a final decision on the submission
is reached. For questions on any submissions with CDRH, please contact
CDRH Product Jurisdiction at <a href="/cdn-cgi/l/email-protection#6f2c2b3d273f1d000b1a0c1b251a1d061c0b060c1b0600012f090b0e4107071c41080019"><span class="__cf_email__" data-cfemail="a4e7e0f6ecf4d6cbc0d1c7d0eed1d6cdd7c0cdc7d0cdcbcae4c2c0c58accccd78ac3cbd2">[email protected]</span></a>. For
questions on submissions to CBER, please contact
<a href="/cdn-cgi/l/email-protection#216263647371534e455442556b5453485245484255484e4f614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="dd9e9f988f8dafb2b9a8bea997a8afb4aeb9b4bea9b4b2b39dbbb9bcf3b5b5aef3bab2ab">[email protected]</span></a>.
Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31266 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P
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