Becker's Healthcare September 29, 2022
Naomi Diaz

The FDA released a final guidance Sept. 28 on what kinds of decision support software it intends to regulate.

The FDA spelled out four criteria that determine whether things like artificial intelligence software that flags medical conditions for physicians are considered diagnostic devices that must be reviewed by the agency.

Criteria that makes your software a device, according to the FDA:

    ...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Medical Devices, Physician, Provider, Technology
Opinion: STAT+: How AI can help satisfy FDA’s drug, device diversity requirements
FDA wants to boost trial innovation with new center at CDER
Stelara biosimilar from Alvotech, Teva approved by FDA
Scopio Labs Receives FDA Clearance For AI-Driven Bone Marrow Analysis Application
STAT+: Grocers are pushing legislation they claim would enhance food safety. Advocates say it would gut FDA rules

Share This Article