开云体育

Thanks, Gordon.

Jack, W8TEE

P.S.? Did you do the article for Rich at CQ??

On Saturday, August 15, 2020, 8:30:11 AM EDT, Gordon Gibby <docvacuumtubes@...> wrote:

Hi Bob -- I check back with the UF group from time to time and the matter is still in review at the FDA.

Crucial?LEARNING POINTS:

1.? ?Earlier and more frequent communications with the FDA would have been a good idea.? ?I think we designed a system with WAY more capabilities?than they were thinking about, and therefore?the uF team apparently had to strip it down to where we had gotten a month or two earlier.? ? More and earlier guidance from communications with the FDA might have saved unnecessary design --- but we ended up with something that could be used for far more critical ventilation

2.? More understanding earlier of the international standards would have made applying to the FDA easier.? ?A lot of time was spent by me and others merely reading through their documents.? ?LUCKILY, I had guessed that they would want the SAFEST possible electrical construction and much of what we did passed muster without too much problem.

3.? PHYSICAL CONTAINMENT was more of an issue than expected.? ? Put the whole thing in a box?? Or Not?? ?Again, a better and clearer direction from FDA earlier might have saved a lot of huge efforts applied later at great effort by many.

4.? THE INTERFACE WITH INDUSTRY was tough.? Thankfully we had FANTASTIC PARTNERS in the altruistic volunteer clubs that filled that need --- those guys were GREAT and I can't sing their praises loudly enough

The amateur radio community really provided incredible support here.? ? A huge amount of very practical knowledge wrapped up all at the same time in many persons.....adding all the academics to it with their very specialized mechanical and other engineering knowledge and we had a great design group.

My thanks to all who have served on this effort.? ?When/If I hear the final outcome I'll let everyone know.

Gordon