FDA Post-Market Plan Gains Support, But Many Details Still Lacking
This article was originally published in The Gray Sheet
Executive Summary
A diverse set of stakeholders backed FDA’s new proposed national post-market surveillance plan during a series of public meetings last week, but participants warned “the devil is in the details.”
You may also be interested in...
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.
Regulatory Briefs: MAUDE Replacement; Electronic Source Data Guidance; Social Media Monitoring
The device center plans to replace the MAUDE adverse events database system by the end of the year. Agency issues final guidance on electronic source data in clinical investigations. FDA purchases social media monitoring software to gauge the effectiveness of its online communications. More regulatory news.