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Conceptual Mockup — For Demonstration Only
app.compliancebrief.health/dashboard
high PriorityJanuary 15, 2025

FDA Issues New Guidance on Digital Health Technologies

Summary

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.

Source

U.S. Food and Drug Administration

View original document →

Audit Trail

SHA-256a1b2c3d4e5f6...

Cryptographically verified and tamper-proof

Archived: January 15, 2025 at 2:30 PM EST

Recommended Actions

1

Review current SaMD development processes against new FDA requirements

2

Update risk management documentation for AI/ML diagnostic tools

3

Schedule compliance team meeting to discuss implementation timeline

Sample preview. Live features: alerts & archive. Summaries and search are planned.

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