The US Food and Drug Administration (FDA) outlined its process for recognizing voluntary consensus standards (VCS) related to regenerative medicine therapies in a new draft guidance document.
The draft guidance, issued 15 June 2022 by the Center for Biologics Evaluation and Research (CBER), outlines how VCS bodies and standards will be evaluated by agency staff, where these standards can be accessed, and how individuals can request recognition of a specific VCS. The guidance also describes how to document the use of a standard in a regulatory submission. The program is modeled after the Standards and Conformity Assessment Program (S-CAP) for medical devices.
“The scientific and manufacturing novelty of many [regenerative medicine therapy] products present unique challenges for meeting regulatory requirements with respect to product testing, product characterization, testing methodologies, manufacturing processes, product quality, and specifications,” CBER wrote in the draft guidance. “Increased development and use of standards has the potential to contribute to regulatory predictability and facilitate the overall development of safe and effective [regenerative medicine therapy] products.”
CBER intends to consider recognition of standards developed outside the federal government by VCS bodies that have open and transparent processes for standards development, include a broad range of stakeholders; have a due process and appeals provisions; and use a fair and transparent consensus process.
Existing VCS related to regenerative medicine therapies may be identified by CBER staff or outside stakeholders for evaluation and potential recognition. CBER plans to begin accepting requests for recognition when the guidance is finalized and has set a goal of 180 days to review requests.
Evaluation will be conducted by subject matter experts in the Office of Tissue and Advanced Therapies (OTAT) and will consider the following elements:
CBER will assign a recognition number and create a Standard Recognition Summary for recognized standards. The agency also plans to maintain a list of recognized VCS on the FDA Regenerative Medicine website and to update the information twice a year.
The use of a recognized standard is voluntary, and sponsors can reference standards not recognized by CBER in regulatory submissions. However, standards that have not been recognized will be subject to FDA’s determination of whether the standard is “fit for the intended purpose,” CBER noted in the draft guidance.
CBER is accepting comments on the draft guidance until 14 September. Comments can be made at www.regulations.gov with reference to docket number FDA-2022-D-0745.
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