Replies to post #150699 on Bioelectronics Corp (BIEL)

[Just No]

I don't think that is correct re/60 Days

https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm

Keep in mind that the agency doesn't have to meet it's own proposed timelines, they are only what happens when everything goes smoothly.

Anyway, the FDA site says 90 days for communication of decision.

If I recall the average was 177 days in 2016. The agency hasn't changed that much since then.

https://www.emergobyul.com/resources/research/fda-510k-review-times-research

Having said that ours should go through fast, i.e. 90 days plus or minus.

[srinsocal]

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/