Bioelectronics Corp (BIEL)

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The 60 day mark is the Substantive Review goal

The FDA goal for 510k Decisions is 90 days.

Since BIEL went through the Pre-Submission Review process the timeline could be accelerated. This process gives FDA guidance on what they want to see in the 510k for a successful application.

Application Timeline

By Day 7 ……………………………………………..Acknowledgement or Hold Letter

By Day 15 ………………………………………...Acceptance Review, Accepted or being Held

By Day 60 ………………………………………...Substantive Review, Proceeding or being Held

By Day 90 …………………………………………..FDA sends final Decision


The 510k Submission was made on 7/12/2018 so we are at day 61 in the process if no days were lost to the application being Held.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

http://www.bielcorp.com/bioelectronics-receives-fda-pre-submission-approval-for-its-relief-of-musculoskeletal-pain-market-clearance-application/