FDA WARNING_LETTER - NuVida Medical LLC - February 19, 2025

Nuvida Medical LLC, located in Phoenix, AZ, was inspected by the FDA from February 10 to February 19, 2025. The inspection revealed that Nuvida distributes several products derived from human tissues, including Procenta, XCELLERATE, completeFT1, and Coll-E-Derm. These products are classified as unapproved new drugs and unlicensed biological products, violating sections 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 351(a)(1) of the Public Health Service Act (PHS Act).

The FDA identified that these products are intended for non-homologous uses, meaning they are used for purposes different from their original functions in the donor. For instance, Procenta, XCELLERATE, and completeFT are used for wound care applications, which do not align with their natural functions as barriers in the donor. Similarly, Coll-E-Derm is intended to support revascularization, a function not inherent to dermal tissue.

Nuvida"s products are also classified as human cells, tissues, or cellular or tissue-based products (HCT/Ps) and must comply with regulations under 21 CFR part 1271. However, they fail to meet the criteria for homologous use, thus requiring additional regulatory approval, including a valid Biologics License Application (BLA).

The FDA"s letter acknowledges Nuvida"s efforts to address some deficiencies but emphasizes that the corrections are insufficient. The company is advised to review its marketing materials and ensure compliance with the FD&C Act and PHS Act. Failure to address these issues may lead to further regulatory actions.