U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. News & Events (Medical Devices)
  4. Workshops & Conferences (Medical Devices)
  5. Webinar Quality in 510(k) Review Program Pilot - October 10, 2018 - 09/10/2018 - 09/10/2018
  1. News & Events (Medical Devices)

Webcast

Event Title
Webinar Quality in 510(k) Review Program Pilot - October 10, 2018
September 10, 2018


Date:
September 10, 2018
Time:
09:00 AM - 10:30 AM EDT
Organized By:

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.