To figure out what's happening, it's worth first looking into the complicated, ever-shifting rules of our own regulatory body.

FDA and fast-tracking


In the U.S., as everybody knows, virtually all products have to go through the FDA, where they are required to meet a set of generic manufacturing guidelines called Good Manufacturing Practice, while also getting pegged into one of three classes, depending on how risky they are - in other words, is it a wheelchair, or a pacemaker?

Class 1 products, which include scalpels, are generally seen as presenting the lowest risk, and usually only need to meet GMP guidelines and register with the FDA. A tiny amount of marginally riskier Class 1 products, about 5 percent, and most Class 2 products, which include ultrasound devices and most imaging equipment will, according to DOTmed's sources, meet FDA's fast-track clearance process for slightly risky devices, known as the 510(k) process. This system, also known as post-market approval, is reserved for devices largely similar in function to something the FDA has already approved.

On paper, this system is quite fast: "The timeline for FDA to approve Class 2 is 90 days," says Chris Schorre, director of global marketing, Emergo Group, one of the largest medical device company consulting groups in the world. "That's the time they legally have to review the application and render the decision."

But, he adds, "The reality is, it takes much longer."

What happens is that the FDA's clock stops after they send you back questions brought up by their initial review - questions it could take months for a company to answer, and this back-and-forth eats up time, and could be responsible for U.S. launch delays. Still, it's fairly smooth, and Schorre says, "The FDA is quite good at reviewing, faster than most countries in the world."

The real lag for a U.S. release comes with Class 3 products, the most risky, which need pre-market approval.

"It's a monster process," says Schorre. "Legally, the FDA has 180 days to approve the application. It involves the submission of clinical trials, and the FDA must approve even the protocol for conducting those trials. It's a very expensive, very time-consuming process. For good reason," he adds, as it covers devices like stents, pacemakers and implantable defibrillators. "Things you're very happy they do an intensive review on."

But is the EU speedier?

If the EU's process is faster, it's only so for Class 3 or Class 2 products (of which Europe has two, Class 2a and Class 2b; the latter's riskier), as the FDA makes minimal demands on Class 1 - so, is the EU faster?

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