publicFDA · United States · Updated Aug 20, 2026
Key Considerations for the Development and Use of Digitally Derived Measures for Clinical Investigations
Clinical investigations must now include justification for DDM selection and ensure that DHTs are verified and validated to support their intended clinical role.
Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: White Paper
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