GG&G

[walker_429]

I absolutely agree the shortest route to a general pain clearance for the OTC Actipatch is the FDA's RWD ( Real World Evidence ) guidance when Finalized. The FDA's new product category PQY allows for this to happen.

Biel would use it's current 510(k) for SWT for which it was granted OTC Clearance and just file an amendment expanding the indications since they now have a legally marketed device Actipatch.

I believe once the new FDA commissioner is in place, this should move along pretty quickly. I remember reading that one of the FDA priorities in 2017 was to finalize the draft guidance for use of RWE / RWD to help with speeding up regulatory approvals before the second half of the year.

As far as divulging my sources.... My friend Juan has a fruit stand near the beach. I visit him once a month, we share a nectarine and talk Biel. ;)