Search Results for citation:"89 FR 106521"

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Search Results: citation:"89 FR 106521"

  • Type:Notice
    Citation:89 FR 106521
    Reading Time:about 2 minutes

    The Food and Drug Administration (FDA) has announced it will transfer regulatory responsibility for medical maggots and medicinal leeches from the Center for Devices and Radiological Health (CDRH) to the Center for Biologics Evaluation and Research (CBER), effective December 30, 2024. This decision was made because these products are living organisms, and CBER is more suited to regulate such products. The transfer only affects which FDA Center will oversee these products and does not change any existing requirements. After the transfer date, all submissions related to these products should be directed to CBER.

    Simple Explanation

    The FDA decided that medical maggots and leeches, which are tiny creatures used to help heal people, will now be looked after by a different part of the FDA because they are living things. This change happens at the end of 2024 and doesn't change any of the current rules for using them.