Last year, FDA published a draft guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The document is presented in a question and answer format and, if finalized, will provide FDA’s interpretation of the regulation.
Human cells, tissues, and cellular and tissue-based products (HCT/Ps) intended for implantation, transplantation, infusion, or transfer into a human recipient are regulated as HCT/Ps if they meet the following criteria:
FDA established regulations for 43 HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases under section 361 of the Public Health Service (PHS) Act. These regulations can be found in 21 CFR Part 1271. Under certain circumstances an establishment may qualify for an exception from the requirements. The circumstances include:
The regulation also states that establishments meeting one or more of the criteria above may be exempt from registering or listing its HCT/Ps independently, but they are still required to comply with all other requirements laid out in the legislation.
FDA released the draft guidance on October 23, 2014 for “comment purposes only,” and on December 22, 2014, the initial comment period closed. However, on October 30, 2015, FDA announced that the comment period would be reopening until April 29, 2016, “to allow interested persons additional time to submit comments and any new information.”
For more information on the proposed regulation, view the full draft guidance here.
If you are interested in in submitting comments or information, you can do so here.
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