Replies to post #325312 on Bioelectronics Corp (BIEL)

[GetSeriousOK]

I wonder what Staelin means by "expedited 510(k)."

If he means "Special 510(k) or Abbreviated 510(k)," I don't think that's going to work. Here's a description of the three types of 510(k) -- looks like a "traditional" 510(k) will be necessary.

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-programs

He must mean "3rd Party Review" (3PRO). Here's a list of devices eligible for 3PRO -- I didn't look very hard to see if the ActiPatch fits in this list but let's assume it's in one of these categories.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm

The problem is that for a 3PRO submission, the new device still needs clinical and safety data. If the higher-power version existed when Ilfeld started, he probably would have used it, but he can't switch now. So..... BIEL needs some test data. Staelin says "near future" so he must have a 2024 plan for testing....... Right?

[Daytime_Lantern]

TP, thanks for the great feedback. Super! It's sincerely appreciated!

GLTA!!