FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. My own work focuses on hospitalization and health utilization over time.

IT 102

IT Screening Hospital Clinic 102

FDA Law Blog

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. data acquisition device).

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105