The FDA has announced a revised implementation date of May 4, 2025, for its recently issued guidance documents:
- Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps
- Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps
While the guidance documents remain final, FDA’s decision to delay implementation reflects a willingness to further review industry concerns and seek additional comments. This extension is in line with the January 20, 2025 presidential memorandum, “Regulatory Freeze Pending Review.”
EBAA will continue our engagement with FDA to ensure a safe and sufficient supply of ocular tissue for sight-restoring procedures. Because of the operational challenges of these recommendations, we have requested an in-person meeting with FDA during which we can openly exchange ideas and understand each other’s views.
Meanwhile, we are developing donor eligibility algorithms that respond directly to FDA’s January 6 guidances, so we can present Dr. Marks with alternatives to their proposed restrictions.
On behalf of our member banks, we submitted electronic comments to these final guidances through the Federal eRulemaking Portal: regulations.gov. We encourage all eye banks to submit their own comments as well highlighting your eye bank-specific concerns and address aspects of the guidance documents that remain unclear.
Questions? Contact Jennifer DeMatteo.