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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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

IDStewardship

JULY 27, 2022

Pharmacists also undertake enhanced roles through nationally commissioned services, including managing minor ailments to avoid the need for medical intervention and clinical management of uncomplicated UTIs using patient group directions. What is the most pressing antimicrobial stewardship issue in the United Kingdom today?

Hospitals 147

Hospitals Clinic Management Labelling Vaccines 147

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. Is the software MDSW according to MDCG 2019-11?

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. Is the software MDSW according to MDCG 2019-11?

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52