Replies to post #145626 on Bioelectronics Corp (BIEL)

[JustGoDeep]

It is Still Expedited by the FDA

Read the following flow chart.

It will answer your question.


https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134034.htm#special

Biel!!

OUT OF THE PARK HOME RUN!!