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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. The final guidance focuses on labeling as a means to effectuate Criterion 4. software or labeling.

FDA 52

FDA Labelling Documentation Communication 52

ISPE

OCTOBER 27, 2022

There are important considerations if the DHTT is classified as a medical device, which may change the level of regulatory controls and evidentiary requirements to support its appropriate use, such as off-label versus on-label use of a device with prior marketing authorization. IMDRF SaMD Risk Categorization. Framework 26.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

There are important considerations if the DHTT is classified as a medical device, which may change the level of regulatory controls and evidentiary requirements to support its appropriate use, such as off-label versus on-label use of a device with prior marketing authorization. IMDRF SaMD Risk Categorization. Framework 26.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52