The FDA has issued two final guidances and two draft guidances, all designed to articulate the agency’s approach to developing and overseeing novel cellular therapies and other regenerative medicine products.
The agency said its suite of four guidance documents constituted a risk-based and science-based policy framework approach designed to support innovative product development while clarifying the FDA’s authority, its enforcement priorities against products deemed to raise potential significant safety concerns.
The two final guidances are designed to clarify the FDA’s interpretation of the risk-based criteria manufacturers must use to determine whether a product is subject to the FDA’s premarket review.
The first guidance is intended to spell out more clearly when cell- and tissue-based products are excepted from the established regulations if they are removed from and implanted into the same individual within the same surgical procedure and remain in their original form. The guidance is a final version of a draft issued under the same title—“Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception”—in October 2014.
The second final guidance is designed to explain to stakeholders—defined as “human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff”— how existing regulatory criteria apply to their products by clarifying the agency’s interpretations of two existing regulatory definitions, “minimal manipulation” and “homologous use.”
The guidance is a final version of a draft issued in December 2014 under the same title, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.”
FDA Issues Final and Draft Regenerative Medicine Guidance Documents