JD Supra

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a ...
JD Supra

FDA promotes pre-approval for changes to devices, LDTs via PCCPs

A predetermined change control plan (PCCP) is documentation describing what modifications will be made to a device after its initial premarket authorization without requiring a new marketing ...
RAPS

Study finds low PCCP utilization among AI-enabled devices

Most manufacturers of medical devices with artificial intelligence (AI) features are not using predetermined change control plans (PCCPs) to manage changes throughout the device's lifecycle, ...
MobiHealthNews

FDA issues guidance on predetermined change control plan for AI-enabled device software functions

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...
RAPS

FDA Issues Draft Guidance on 510(k) Device Modifications

The US Food and Drug Administration (FDA) on Friday released two draft guidances for public comment clarifying its policy for when manufacturers should submit a 510(k) for changes made to a medical ...