Replies to post #83955 on Bioelectronics Corp (BIEL)

[riccikeeper]

Try not on this board to believe everything you hear!

[fuente]

Fuente states Draft Guidance is, technically, not yet in effect

That's not the key issue - the key issue that even if the draft was in effect, it would not apply to BIEL. But to answer your question, it is not 'technically' in draft...it is 'actually' in draft.

The first page of the the document, at the top - 'Draft - not for implementation'.

There is a schedule for when it will become an actual guidance.

[Det_Robert_Thorne]

Comments to draft FDA document requested by 10/25/16

If the comment period for this draft guidance on Real-World Evidence is open until Oct 25, 2016, then the odds of the final guidance going into effect before the end of 2016 are quite low:

https://www.federalregister.gov/documents/2016/07/27/2016-17750/use-of-real-world-evidence-to-support-regulatory-decisionmaking-for-medical-devices-draft-guidance

I wouldn't expect it to have any impact on BIEL until 2017.