FDA post-market surveillance and "experimental/investigational"

[sahuaro]

Since insurance companies appear to be at liberty to define reality in whatever terms benefit them, this piece of information may not be helpful in appeals, but it is worth throwing in.
HealthNet Arizona denied my appeal, citing FDA requirements in its premarket approval of the Prestige ST, for postmarket surveillance, i.e., collecting data on outcomes and adverse events for an additional seven years. HealthNet used this requirement to claim that the Prestige ST is experimental/investigational. I just received an e-mail response from FDA indicating that the FDA does not consider devices with such postmarket surveillance requirements as experimental/investigational.

[ans]

Did I just read this? It seems out of "Alice In Wonderland", unreal.

Thanks for sharing this and sorry about your outcome - so far.

ans

[Slackwater]

Originally posted by ans:
Did I just read this? It seems out of "Alice In Wonderland", unreal.

Thanks for sharing this and sorry about your outcome - so far.

ans
"Alice in Wonderland" is so well said, LOL on this side. Too amusing.

My insurance company also wrote "experimental".

Sahuro, may I please ask, where did the email come from stating "the FDA does not consider devices with such postmarket surveillance requirements as experimental/investigational"? Any web pages on FDA that I can look at?

I am two(2)-level ADR candidate, not FDA approved, so experimental is probably the correct phrase, but I do want to see if I can progress on my 2nd appeal with this wording.

[sahuaro]

I e-mailed the FDA through their website and got a response within 24 hours. I'm not very computer savvy so I don't know how to post the response here but if you PM me with your e-mail address, I can forward it to you. I wish I had thought of asking this question of the FDA before my appeals were exhausted--but if this can help others, it would be great.

[eileen gallagher]

Sahuaro,
I have been thru the appeal process and my company is saying that ADR is expermential and unproven. My old lawyer has stated that if the FDA considers a product experimental and unproven that we have no case. How and who did you contact in the FDA to get your letter. I need to talk to them.
thanks eileen