Vendors to spend how much for FDA PMTAs?

[ENAUD]

I don't see how it can happen that way.

Second and third generation products will NEVER meet the PMTA requirements.
Well, unless those requirements change of course.

But as currently written?
A snowball has a better chance in hell.

Sure they can, as long as they make sure that there proprietary connector cannot accept anyone else's atomizers they could, bigger battery, denser vapor, heck, they could even do TC, with a proprietay "system" they could control all of the variables including a few flavors of juice, which could be dispensed via some secure connection, or pre-sealed in a disposable capsule.

Proprietary filling method including carto/tank and bottle design, carto/tank and battery connection? Before 8/8/2016?

That date means nothing to someone with long range goals, they can take their time, maybe even finagle some sort or substantial equivalency incrementally improving upon their product line.

They are safe to steal the industry and re-make it their own vision, with their money stream neatly protected by the MSA's and the FDA being their muscle man.

 

[DC2]

Sure they can, as long as they make sure that there proprietary connector cannot accept anyone else's atomizers they could, bigger battery, denser vapor, heck, they could even do TC, with a proprietay "system" they could control all of the variables including a few flavors of juice, which could be dispensed via some secure connection, or pre-sealed in a disposable capsule.

Okay, I see where you're going with this now.
And yeah, it isn't out of the realm of possibility I guess.

But each of those things is one big huge PMTA to prove no "harm" to the sheep.
And I still maintain that said "proof" is nearly impossible to come by as currently required.

But if a cigalike can pass through, then who knows what the FDA will "allow" going forward.

But I'm kind of with @Kent C on this one...
In that I'm not yet sure Big Tobacco even gets one through.

 

[ENAUD]

Okay, I see where you're going with this now.
And yeah, it isn't out of the realm of possibility I guess.

But each of those things is one big huge PMTA to prove no "harm" to the sheep.
And I still maintain that said "proof" is nearly impossible to come by as currently required.

But if a cigalike can pass through, then who knows what the FDA will "allow" going forward.

But then again, who get's to decide whether a PMTA passes or fails? Me thinks down the road, maybe some dirt might come out, Somebody should be doing some serious financial investigation on the folks that wrote these dirty rules into law...

 

[Truthdog]

I don't see how it can happen that way.

Second and third generation products will NEVER meet the PMTA requirements.
Well, unless those requirements change of course.

But as currently written?
A snowball has a better chance in hell.

So lets change the PMTA requirements. Medical devices that don't have a predicate product can submit a De Novo application which is likely easier than PMTA by far. Testing to show safety and effectiveness is necessary, and use of GMPs, but those are hurdles that ProVape and other good devices, as well as quality made liquids could clear IMO.

 

[DC2]

So lets change the PMTA requirements.

Give me a good eraser and a couple of hours and I'll take care of it.