CDRH Details Path Forward For National Post-Market Surveillance System
This article was originally published in The Gray Sheet
Executive Summary
The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.
You may also be interested in...
Task Force Advocates Making Registries Better Than Sum Of Their Parts
The FDA-endorsed Medical Device Registry Task Force maps out a path toward "coordinated registry networks," starting with pilot projects and 11 prioritized device categories.
Planning Board Urges FDA To Launch Postmarket Incubator Project
FDA and its collaborators should launch an incubator project with fact-finding activities and pilot programs to help launch a national postmarket surveillance system that builds on Unique Device Identifiers (UDIs), registries, and innovative data capture and analysis strategies, a multi-stakeholder planning board recommends.
Planning Board Proposes Postmarket Device Surveillance Timeline
A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.