FDA Law Blog

OCTOBER 10, 2022

Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Here again, FDA’s novel interpretation of statutory terms effectively narrows the scope of information that a software product can display, analyze, or print and still be considered Non-Device CDS.

Clinic 52

Clinic Medical Provider Patients 52

GeriPal

JUNE 20, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Alex 13:24 Eric is pushing on the like, the clinical, practical stuff. That can be incredibly informative. I mean, I can informative. Eric 13:23 Go ahead, Alex.

IT 120

IT Patient-Centered Patients Clinic 120

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. It’s because they literally couldn’t access the information.

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.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105