Quality in 510(k) “Quik” Review Program Pilot.

On September 6^th, the FDA launched the Quality in 510(k) “Quick” Review Program pilot.  This program is expected to help manufacturers simplify the premarket notification submission process for certain moderate-risk medical devices.  The pilot will also evaluate whether the FDA’s eSubmitter software will result in more organized submissions, making the review process more efficient.  This new Quik Review Program allows the manufacturer to use the FDA’s free eSubmitter program to compile all of the information required for a 510(k) application, save it all, and submit an electronic copy of the application to the FDA’s Document Control Center rather than submitting both a hard and an electronic copy.

Submissions that are eligible for the Quik Review Program pilot will not be required to go through a Refuse to Accept review.  Submissions will go through an interactive review which would give companies a final decision within 60 days, without placing the file on hold.  The list of eligible product codes can be found on the Quik Review Program Pilot website.  The FDA is holding a webinar on October 10, 2018, to share more information about the pilot program and answer any questions from the industry.

 

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