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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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 guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

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FDA Labelling Documentation Communication 52

Hospital Pharmacy Europe

FEBRUARY 17, 2025

A 2016 Cochrane review on non-medical prescribing reported that pharmacist prescribers were able to deliver comparable prescribing outcomes to that of doctors. Hospital pharmacists must work to build trust with both patients and medical colleagues in embedding pharmacist prescribing to clinical practice.

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Hospitals Patient Care Clinic Management Communication 59

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.

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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

Hospital Pharmacy Europe

MAY 9, 2024

Bhat, head of department – central laboratory and consultant microbiologist and infection control officer at St Martha’s Hospital, Bengaluru, India, showcased her work with ChatGPT in the clinical microbiology laboratory. to 56.5%), compared to the previous PPS conducted in 2016/17 (prevalence of 32.9%).

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Hospitals Communication Clinic Management Documentation 52