NuVida Medical LLC
FDA issued a warning letter to NuVida Medical LLC (Phoenix, AZ) after a February 2025 inspection found the company distributing four unapproved biological products — Procenta, XCELLERATE, completeFT, and Coll-e-Derm — derived from human amniotic, placental, and dermal tissue without an approved Biologics License Application (BLA). The products were marketed for wound care and revascularization applications that FDA determined constitute non-homologous use under 21 CFR 1271.10(a)(2), disqualifying them from the HCT/P exemption and making them unlicensed biological products and unapproved new drugs. FDA found NuVida's voluntary website corrections insufficient because the products' intended non-homologous uses remained unchanged. Failure to adequately respond may result in seizure and/or injunction.
Flagged claims (2)
a prehydrated human acellular dermal matrix that retains angiogenin and collagen type IV. Angiogenin and collagen type IV may play a key role in supporting revascularization.
a placental tissue allograft that may be used as a protective barrier in wound care applications. The natural properties of amniotic tissue provide mechanical protection and growth factors to support the management of acute and chronic wounds.
Required actions (3)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
We advise you to comprehensively review your website and other labeling and marketing materials to ensure that you are lawfully marketing your products in full compliance with the FD&C Act, the PHS Act, and their implementing regulations.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
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