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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 [www.gpo.gov]
[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, 
[email protected] or [email protected].

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 [email protected]. For 
questions on submissions to CBER, please contact 
[email protected].

    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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