Lexology January 31, 2025
Ropes & Gray LLP

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new draft guidance documents addressing artificial intelligence (“AI”). One is a long-awaited draft guidance addressing marketing submission and lifecycle management considerations for AI-enabled medical devices, titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” (the “Device AI Draft Guidance”). The other is a draft guidance addressing the use of AI tools in the drug product lifecycle, titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products” (the “Drug AI Draft Guidance”). Although they address different...

Today's Sponsors

Venturous
Got healthcare questions? Just ask Transcarent

Today's Sponsor

Venturous

 
Topics: AI (Artificial Intelligence), Digital Health, FDA, Govt Agencies, Technology
Search Funds growing interest in Healthcare Technology
The Hinge Health S-1 Breakdown
Executive Insights: 4 Key Takeaways from HIMSS and ViVE 2025
5 Digital Health Areas To Be Impacted By The FDA Layoffs
Telehealth regulations in Washington, D.C.: The most pressing need in policy

Share This Article