FDA outlines process for recognizing standards for regenerative medicines

The US Food and Drug Administration (FDA) has issued final guidance describing its process for recognizing voluntary consensus standards (VCS) to spur the development of regenerative medicine therapies (RMTs) evaluated within the agency’s Center for Biologics Evaluation and Research (CBER).

RMTs include cell therapies, therapeutic tissue engineering products, human cell and tissue products and combination products. RMTs may also include some human gene therapies, such as genetically modified cells that lead to a sustained effect on cells or tissues, and xenogeneic cell products.

This program is modeled after the formal standards and conformity assessment program (S-CAP) for medical devices. The guidance addresses the procedures for recognizing standards and documents how to use a standard in a regulatory submission. It also features a question-and-answer section that addresses whether standards can be used if they are not officially recognized by the agency, how often VCS will be reviewed for recognition, and where these standards will be posted.

The guidance is little changed from the draft issued in June 2022 (RELATED: CBER outlines recognition process for regenerative medicine therapy standards, Regulatory Focus 17 June 2022).

“CBER encourages the use of appropriate standards in the development of CBER-regulated products. The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products,” FDA announced.

FDA specified that to be recognized as a VCS, there must be an open process for participating in standards development, the standards development process must involve a broad range of stakeholders, a fair and impartial process must be in place for resolving conflicting views, and there must be an appeals process.

Additionally, FDA will use the following criteria to determine its recognition of a standard:

The standard does not conflict with the current laws, regulations or policies
The standard is scientifically sound
The standard can be used to assess a regulatory submission for a RMT product
Use of the standard may facilitate the ability of sponsors to meet regulatory requirements for RMT products

Public comments on the draft guidance were generally supportive but sought more details from the agency on the types of VCS recognized and the process for engaging FDA through the program (RELATED: Industry seek clarity on FDA’s standards recognition process for regenerative medicines, Regulatory Focus 21 September 2022)

FDA’s Center for Drug Evaluation and Research (CDER) also recently finalized guidance that establishes a consensus standards program for evaluating the quality of drugs (RELATED: FDA finalizes guidance on drug quality consensus standards recognition program, Regulatory Focus 26 July 2023).

Final Guidance

FDA outlines process for recognizing standards for regenerative medicines

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