2023-11570: Human Cells, Tissues, and Cellular and Tissue-Based Product Establishments That Are Improperly Registered in the Electronic Human Cell and Tissue Establishment Registration System Due to Lack of Annual Registration Update; Action Dates
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The Food and Drug Administration (FDA) is announcing its intention to begin inactivating the registration of establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) that have not updated their registration during the annual update period, in accordance with FDA regulations, in the electronic human cell and tissue establishment registration system (eHCTERS). FDA regulations require establishments that manufacture certain HCT/Ps to update their establishment registration annually. These regulations also require establishments to amend their registration within 30 calendar days of certain changes.
The agency’s own summary, as published.
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