Medical Device Regulation: “FDA is tougher than CE mark” shock

According to MedCity News, the US site covering news, opinion and analysis from today’s medical cities, “The medical device industry seems to be in love with Europe”.

The article goes on to suggest that U.S. Food and Drug Administration’s(FDA) perceived inconsistency, risk aversion and foot-dragging, drives many in the device industry to turn to the European Union’s CE Mark for their initial regulatory approval.

A survey earlier this year by Northwestern University researchers found that two-thirds of small American med-tech firms are getting European market approval first, compared with only 4 percent who report going the domestic route first and getting FDA approval.

Surely t’was ever thus?

“The FDA’s caution leads many companies to just give up on potentially lifesaving ideas”

And is Europe really a medical devices paradise?  The article says no and it goes on to discuss the do’s and don’t’s of seeking European CE mark approval, which is fair enough.  But the reality from our own experience of trawling the press releases, websites and news releases of the medical device world rather suggests that it’s not that tricky.  Perhaps we should formalise it by doing our own survey, but anecdotal analysis suggests that if a product can be approved according to the 510(k) route in USA, where demonstrating substantial equivalence to an existing device or technology is the essential basis for approval, unless FDA have asked for substantial clinical data, then CE marking and FDA approval are not that different.

Where it gets tasty is when we consider devices with a perceived higher risk, either because of their type or because of the indication.  In Eu this broadly means devices which would be called Class 3 or even Class IIb, so to cut a very long story short, implantables and absorbables and things delivering energy to the patient.  In USA these types of device usually (though not always)  require pre-marketing approval from FDA, the so-called PMA, which usually demands pre-clinical and clinical data with a requirement for multiple centres and large patient numbers in studies that are approved under investigational device exemption (IDE) and monitored closely.

In Europe, in contrast to FDA, the notified body charged with policing the regulations does not get involved with the study design and usually asks to see data far later in the process than FDA does.

So who’s right?  Are FDA too demanding to the extent that smaller companies with lower unit demand products might as well just not bother (and in so doing deprive Americans of some really neat new technologies) or is the Eu Medical Device Directive(MDD) and its interpretation and implementation too low a barrier and as such allowing products through too easily?

Who knows?  What we do know though is that we’re ever so slightly uncomfortable about the number of times we encounter press releases from companies saying that FDA is now allowing them to do a bit more study under their IDE conditions, on products that have been freely available for one, two, three years or more in Europe.

If a device is not good enough or ready to get through FDA’s scrutiny how comfortable do you really feel about using it on your patients, because doing so frequently means you’re using a product which has not undergone significant clinical study (at least not to FDAs standards) and expert panel review.  And these FDA panel guys are not just bureaucrats.  Panels will feature clinicians relevant to and expert in the technology.  From another perspective, if a company has not subjected its product to FDA approval it means it either has made a strategic decision not to do so or it doesn’t have the clinical support , yet Eu healthcare providers with all the available clinical and cost/benefit analysis data at their disposal are buying it.

Returning to the article for a minute, which can be found here, it goes on to warn US companies of the pitfalls to avoid when seeking CE mark approval for their products.  While this is clearly a pitch for the main contributor’s regulatory consulting business, it’s all true (and more).  But what’s also true is, even with potential pitfalls, it’s no FDA.

In another article, penned by Fox Business’s John Stossel, he suggests that “The FDA’s caution leads many companies to just give up on potentially lifesaving ideas”, his focus being mainly on FDA’s cautious attitude to regulation of apps designed to aid remote patient monitoring.

This point is made so frequently that one almost starts believing that FDA sits on its hands in a deliberate and contrary fashion, not allowing those naughty Medtech companies to play.  In a very real sense FDA is in a cleft stick.  If it relaxes for one minute and something goes wrong it gets accused of not protecting Americans.  If it holds a tight line it gets Medtech companies and industry commentators on its case.  The pragmatic position is probably that adopted in the Eu by the brilliantly unifying Medical Device Directive.

So here’s a concluding position for you to ponder: Did anyone ever come to harm or even die because a product was released in Eu that wouldn’t have got through FDA?  If the answer’s “no”, we can conclude Eu MDD implementation is about right.  If the answer’s “yes and there are many examples”, then we must conclude differently.

We’re guessing the information isn’t readily available to help us, so the debate will endure.

Source: medlatest staff