REGULATORY UPDATE: FDA Extends Implementation Date for Two HCT/P Guidances

The Food and Drug Administration has extended the implementation deadline for two final guidance documents that aim to reduce the risk of transmission of Mycobacterium tuberculosis (Mtb) and sepsis through human cells, tissues and cellular and tissue-based products (HCT/Ps). Facilities now have until May 4 to implement the recommendations. 

FDA originally issued the guidance documents on Jan. 7 for immediate implementation in response to a multi-state outbreak of Mtb — the bacterium that causes tuberculosis — in recipients of allograft bone products. At that time, the agency recommended that facilities adopt the updates as soon as feasible, but no later than four weeks after issue of the guidances.

In a Federal Register notice, FDA stated that the revised implementation date will allow the agency to review public comments received before the original deadline and further evaluate the guidance. The delay also aligns with President Trump’s Jan. 20 memorandum, Regulatory Freeze Pending Review, which calls for additional review of pending regulations.

AABB encourages facilities preparing for implementation to review AABB’s member-exclusive toolkit, “AABB Resources to Support Implementation of FDA’s Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) and Sepsis by HCT/Ps.” The toolkit includes questions and flowcharts to assist in developing protocols that meet donor eligibility recommendations.