Random Thought: FDA Approval

[runagain]

We must not forget that both the ProDisc lumbar and Charite Lumbar discs were subjected to a post approval period. So you have the pre approval part and then the post approval period. This I believe gave the health insurance companies the opportunity to say that despite FDA-approval, the ADRs had to undergo additional testing and therefore were still "experimental". That was a lie about being experimental but that is what they think. So we are talking several years for that process. The ProDisc-L was approved in August 2006 and just reached final testing this year. The final report was due 1/29/2010 and the information on the FDA official site for medical devices post approval has not yet been updated.

[MDE]

You know, during the process that eventually resulted in me going to Spain for a pair of M6's, I was surprised to learn that the M6 was not (as of Sept'09) approved for use in India or Costa Rica?! I just assumed that the Indian's would let you implant a roofing nail and call it an ADR. I don't know what their standards are, but fortunately the Indians seem to be more stringent than I had figured.

What you're not accounting for is that each country typically has their own regulatory body. This means effort would have to be spent on getting the device approved in that country (even if it is a simple process) Typically, business decisions go where the money is, and try to get their the fastest. For a while now, almost everyone has used europe as the gateway to the US because it is/was a good way to get good clinical data. The markets are a bit different though. In Europe, you sell the instrumentation to implant the device, as well as the implant. This means that a hospital will purchase a "set" and get it restocked as they go through implants.

In the US, the Implants typically are being sold for ~four times the price they are in europe, but the instruments are loaned for free to the hospitals. The US market is also much larger, so the main goal is to get the implant on the market in the US.

I don't know how accurate the claims, but I read a year or so ago that the EU approval process was faster in part because the investigational process/device had only to be proven safe, not effectual. If that is true, that is what is being changed?

MDE, would you define a couple of terms for the less knowledgeable of us (me).

PMA - ???
CE registration - ???

Thanks, Jeff

Yes, The EU is now requiring efficacy data and also reclassing some devices. I do not know exactly how this will effect distinctions between "class 2B" and "Class 3" devices. (examples would be a pedicle screw fusion system versus an artificlal disc respectively)

PMA is Pre Market Approval. This is the FDA saying that you can do a clinical trial (which they also have to sign off on the structure of) that will then be reviewed to see if you are allowed to market the device. Typically the FDA requires that you already have clinical data prior to a device being allowed to do clinical trials in the US.

CE registration is the European equivelant of "market approval" from the FDA. The CE mark is found on many products including household electronics. It basically says that you're allowed to sell the device. it is required on all implants and instruments to be used in a clinic in Europe.