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Originally Published MD&DI March 2007

STERILIZATION

Who Regulates Tissue?

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In the United States, all establishments that collect, process, or handle human cells, tissues, and cellular or tissue-based products (HCT/Ps; as defined in 21 CFR 1271.10) must register with FDA. The following list identifies the FDA centers that hold the primary regulatory control for allograft tissue:
  • Minimally manipulated allografts: Center for Biologics Evaluation and Research (CBER).

  • Allograft tissue with drugs: Either CBER or the Center for Drug Evaluation and Research. A decision is made for each application.

  • Allograft tissue used in a device: Either CBER or CDRH. A decision is made for each application.

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