Medical Device Link.

NEWS TRENDS

The Postmarket Transformation Leadership Team selected nine recommendations for immediate action. They are the following:

1. Create medical device cross-cutting collaborative product groups to better integrate premarket, postmarket, and enforcement efforts.



2. Develop methods and metrics for tracking and assessing progress in CDRH's performance in handling postmarket issues.



3. Aggressively pursue the development of unique device identifiers for medical devices, in collaboration with industry and healthcare providers, to easily identify specific devices when postmarket questions are raised.



4. Optimize CDRH's passive surveillance systems by making electronic reporting of adverse-event data mandatory.



5. Make medical device reporting and other postmarket data broadly available to staff by revising and updating the MAUDE system, and expanding the premarket data warehousing effort to include postmarket applications.



6. Transform the quality and quantity of CDRH and ORA interactions through increased collaboration within CDRH and among CDRH, ORA, and the Office of Chief Counsel.



7. Develop and implement a risk-communication strategy to maximize CDRH's ability to communicate information in a clear and timely way to practitioners, patients, and consumers.



8. Design a pilot project to test whether quantitative decision-making methods can be useful in regulating medical devices across the total product life cycle.



9. Increase active surveillance by enhancing MedSun programs that reach out to participants and get answers to pressing public health questions.