FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...
Verification confirms publisher identity (repo ownership), not code safety. The security scan covers known CVEs and suspicious install scripts — it cannot prove the absence of malicious code.
FDA AI/ML Software as a Medical Device Action Plan + 510(k) + PMA + De Novo pathways for US MedT...