Lexology April 10, 2024
Troutman Pepper

On March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for incorporating artificial intelligence (AI) into medical products within the FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP). The report reflects the FDA’s commitment to both fostering innovation in medical technology and safeguarding patient health through regulation, standard-setting, and monitoring.

The FDA identifies four priorities for the development and use of AI across the medical product life cycle:

(1) Fostering collaboration to safeguard public health;

(2)...

Today's Sponsors

Venturous
Got healthcare questions? Just ask Transcarent

Today's Sponsor

Venturous

Continue Reading

 
Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Medical Devices, Technology
Related Articles:
‘He needs to do much more’: RFK Jr.'s measles response under scrutiny
Marty Makary, Who Made His Name Bashing the Medical Establishment, May Soon Lead FDA
Gutting FDA Won't Make America Healthy
Google’s Pixel Watch 3 Loss of Pulse Detection Feature Receives FDA Clearance
FDA Annual Flu Vaccine Meeting and CDC’s ‘Wild to Mild’ Campaign Canceled

Share This Article