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The FDA has released updated guidance for software as a medical device (SaMD), including new requirements for clinical evaluation and risk management processes. This affects all digital health companies developing AI/ML-based diagnostic tools.
U.S. Food and Drug Administration
View original document →a1b2c3d4e5f6...Cryptographically verified and tamper-proof
Review current SaMD development processes against new FDA requirements
Update risk management documentation for AI/ML diagnostic tools
Schedule compliance team meeting to discuss implementation timeline
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