What FDA Software as a Medical Device (SaMD) Premarket Review Framework (2026 Update) requires
The FDA regulates Software as a Medical Device (SaMD), including AI/ML-enabled software, using a risk-based approach for premarket submissions (510(k), De Novo, or PMA). Manufacturers must provide comprehensive documentation on software design, risk management, clinical evaluation, cybersecurity per Section 524B and the February 2026 guidance, Software Bill of Materials (SBOM), and lifecycle processes under the QMSR (21 CFR Part 820, aligned with ISO 13485). Higher-risk SaMD requires enhanced evidence where failure could cause serious harm or death.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-820
SHA-256 integrity: bba2b6d2a4773e59a6adff6bd0696000ec134264c6eb5a73c7f1480b25ec667a
Primary Citations — 5 traced to source
- FDA Guidance: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (February 2026)
- Section 524B of the Federal Food, Drug, and Cosmetic Act (cybersecurity requirements for cyber devices)
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