The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA gives no rationale for interpreting the apparently broad statutory term “medical information” in such a restrictive manner.

FDA 52

FDA Labelling Documentation Communication 52

pharmaphorum

AUGUST 26, 2021

UK-based Optellum has developed an AI-powered clinical decision support – called Virtual Nodule Clinic – that it says acts as a “digital biomarker”, looking for signs of cancer in computed tomography (CT) scans. It was approved by the FDA in March, and is starting to roll out in US hospitals.

Hospitals 72

Hospitals Clinic Management FDA 72

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical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

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical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

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52