← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEDecember 30, 2024NOTICE — NO LEGAL EFFECT

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

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGBiologicsDevice
Document type
Notice
Agency
Health and Human Services Department
Published
December 30, 2024
Document number
2024-31266
Docket
FDA-2024-N-5702
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.

Abstract as published in the Federal Register.

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