ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Category I: SaMD that provides information to inform clinical management for a disease or condition in a nonserious situation or condition is a Category I and is considered to be of low impact.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Category I: SaMD that provides information to inform clinical management for a disease or condition in a nonserious situation or condition is a Category I and is considered to be of low impact.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

The FDA Law Blog

OCTOBER 10, 2022

Certainly we would expect clinical communications, as well as HCP-patient communications, to include discussions of test results over time as these would seem highly relevant to clinical decision making. The final guidance focuses on labeling as a means to effectuate Criterion 4. software or labeling.

FDA 52

FDA Labelling Documentation Communication 52