MedTech Dive December 4, 2024
Elise Reuter

By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.

The Food and Drug Administration issued a much-anticipated update on Tuesday detailing how it plans to regulate changes to artificial intelligence-enabled medical devices after the agency has authorized a product.

The agency shared final guidance on what information it wants to see from manufacturers that propose pre-determined change control plans (PCCPs), a new type of regulatory framework that allows for certain modifications to a device after it is on the market.

The FDA first introduced the concept of PCCPs in a 2019 discussion paper about modifications to AI- or machine learning-based devices. Currently, devices on the market that use AI or machine...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Medical Devices, Technology
Related Articles:
FDA updates definition of 'healthy'
FDA Clears Withings’ New Blood Pressure Monitor That Allows Providers to Communicate Directly with Patients
4 takeaways from the FDA’s first digital health advisory committee
FDA commissioner, a veteran cardiologist, highlights ongoing issues with US healthcare system
FDA commissioner urges health systems to strengthen AI quality oversight

Share This Article