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# FDA HCT/P Enforcement Discretion Ending 5/31: Marks
- URL: https://www.fdaweb.com/fda-hct-p-enforcement-discretion-ending-5-31-marks/
- Published: 2021-04-21T12:00:00.000Z
- Updated: 2026-09-14T16:55:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149162

CBER director **Peter Marks** says there will be no further extensions to FDA’s intent to exercise enforcement discretion on IND and premarket approval requirements for certain regenerative medicine products. The enforcement discretion initially was to expire 11/2020 but was extended to 5/2021\. In an online [post](https://www.fda.gov/news-events/fda-voices/advancing-development-safe-and-effective-regenerative-medicine-products?ref=fdaweb.com), Marks says there will be no further extension past 5/31.

The enforcement discretion was intended to give manufacturers time to determine if certain requirements apply to their products and, if an application is needed, to prepare and submit the appropriate application to FDA, Marks writes. He says that since 11/2017, FDA has worked with product developers to help them determine if they need to submit an IND or marketing application and, if so, how they should submit their application to the agency. He says FDA developed programs to provide opportunities for engagement between human cell, tissue, and cellular and tissue-based products (HCT/Ps) manufacturers and the agency, including the Tissue Reference Group rapid inquiry program that helped manufacturers of HCT/Ps obtain a rapid, preliminary, informal, non-binding assessment from FDA regarding how specific HCT/Ps are regulated.

“Despite all of FDA’s efforts to engage industry, there continues to be broad marketing of these unapproved products for the treatment or cure of a wide range of diseases or medical conditions,” Marks says. “Many of these products appear to be HCT/Ps that are regulated as drugs, devices, and/or biological products subject to premarket approval requirements. The wide extent of the marketing of such unapproved products is evidenced by their inappropriate advertisement in various media and by the number of consumer complaints about them submitted to FDA.”

Marks says FDA will continue to take action against unlawfully marketed products.