Replies to post #21205 on Bioelectronics Corp (BIEL)

[gman22]

So....because BIEL is forming a new category....it should be worth lots more. At least lets hope that is the case.

[uksausage]

I cannot find anywhere on the FDA site to list De Novo device approvals.
pretty sure the numbers quoted were for PMA'a which are not as easiy as 501k apporvals.

interestingly I found this I hadnt seen before:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm

look at "attachment 1" = near bottom of page.
it shows in flow chart form the process and claims <= 60 days per review cycle once you submit the De Novo app following 501k NSE.


so if the FDA have not contacted BIEL for anything to do with the reviewing process after 60 days we should a) not hear any more request and b) be counting down to decision day.

on approval you can immediately market in the USA.