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In this section: Workshops & Conferences (Medical Devices)

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

Office of Communication and Education

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.

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