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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Published 9 July 2021. Updated 29 November 2021. Published 22 December 2021.

article thumbnail

Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Published 9 July 2021. Updated 30 August 2021. IMDRF SaMD Risk Categorization. Gilbert, A.