FDA’s AI Device Guidelines Evolve: How Medtech Can Adapt
FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing comprehensive lifecycle guidance for AI-enabled software, tightening cybersecurity obligations, and expanding real-world evidence (RWE) use. Medtech manufacturers who ‘bite the bullet’ now investing in GMLP, bias mitigation, secure-by-design update infrastructure,…
