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Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements December 2018

Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements December 2018

The Food and Drug Administration’s (FDA) comprehensive regenerative medicine policy framework is intended to spur innovation and efficient access to safe and effective regenerative medicine products.  An overview of the November 2017 framework outlined in a suite of four  guidance documents, is available on FDA’s website.

In the agency’s final guidance entitled, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products:  Minimal Manipulation and Homologous Use, FDA informed manufacturers, health care providers and other interested parties about the agency’s compliance and enforcement policy for these products.  The guidance outlined FDA’s intent to exercise enforcement discretion for certain products with respect to FDA’s investigational new drug application (IND) and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns for the first 36 months following issuance of the guidance. This period allows manufacturers time to comply with the IND and premarket approval requirements and engage with the FDA to determine if they need to submit an IND or marketing authorization application, and if so, submit their application to FDA. 

FDA is currently applying a risk-based approach to enforcement, accounting for how products are being administered as well as the diseases and conditions for which they are being used, and would like to remind manufacturers, health care providers and other interested parties that the 36-month period during which FDA intends to exercise enforcement discretion will end in November 2020.  Manufacturers and health care professionals who have any uncertainty regarding the regulatory status of their products who have not already done so are encouraged to contact FDA well in advance of that date to determine if their products are subject to the agency’s premarket approval requirements. 

For more information on how to contact FDA to obtain a recommendation or decision regarding the classification of a human cell, tissue, or cellular or tissue-based product (HCT/P), or for further information about IND requirements for biological products, please see pages 23 and 24 of the guidance entitled, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.