Webcast
Event Title
Webinar Quality in 510(k) Review Program Pilot - October 10, 2018
September 10, 2018
- Date:
- September 10, 2018
- Time:
-
9:00 AM - 10:30 AM ET
- Organized By:
-
Organizer
Webinar Materials
On October 10, 2018, the FDA hosted a webinar about the Quality in 510(k) Review Program pilot. The goal of this pilot program was to simplify how manufacturers of certain moderate-risk medical devices complete a premarket notification (510(k)) submission, and to evaluate if the FDA’s free eSubmitter software will result in well-organized submissions that can be reviewed more efficiently. More efficient reviews will help promote timely access to safe, effective, and high-quality medical devices.