Watching the Watchman and watching FDA

October 17, 2014 – 8:04 AM | By Mark McCarty | No comments yet
Sartorially anachronistic, but you get the point

Different uniform, but he carries a stick, too

There is certainly no shortage of stories (or controversy) in the world of med tech, and here are a couple of stories that kept a lot of people glued to their computer screens (more or less) recently.

FDA watches the Watchman

FDA has heard a third affirmative vote from an advisory committee on the question of the Watchman left atrial appendage closure device, although the vote in favor of the device was close for the second consecutive time. It’s an interesting predicament for the agency because members of the Office of Device Evaluation are clearly uncomfortable with the Watchman, but it’s becoming increasingly difficult for the agency to dismiss the views of physicians.

However unsettling FDA’s misgivings might be, it does not have to go it alone. It has a safety net called the Centers for Medicare & Medicaid Services, which along with FDA provided a case study for inter-agency coordination with their handling of the transcatheter aortic valve (a.k.a., TAVR).

We note, however, that CMS had to cough up more for the Edwards Sapien device within a year of rendering its coverage decision because some perfectly qualified centers couldn’t use the device without losing money. We might reasonably expect the same kind of loopy governmental behavior for the Watchman, which has been available in Europe for how long?

In any event, Boston Scientific won’t have the market to itself for long. St. Jude Medical is working on the second iteration of the Amplatzer device, and these are not the only companies working on this kind of technology. FDA won’t have to watch the Watchman for long.

Industry watches the device classification rule

It’s not often a regulatory writer remembers a med tech draft guidance or proposed rule with a lot of clarity (FDA turns out so many of them). But who can forget the announcement in the March 25 Federal Register for device classification procedures?

There’s a ton in there, and my write-up in the March 26 edition of Medical Device Daily didn’t come close to covering it all. One of the more obvious examples of saber rattling was FDA’s observation that some stakeholders think clinical trials are great special controls for class II devices. I said in my write-up that FDA “has 90 days to take on the near-certain rebellion the rule seems destined to provoke.”

Did I go out on a limb with that observation? Maybe, but the agency extended the comment period to Sept. 22, and there hasn’t been much noise about it in the nearly four weeks that have since passed. The draft rule discusses matters such as a class III device designation based on “heightened potential risk,” which strikes this scribbler as highly elastic language. And that’s far from an exhaustive reading of the document.

It seems unlikely that this proposed rule will just die off gracefully, but it will be trimmed back by quite a bit. A good example of FDA’s regulatory ambitions and the attendant resistance is the guidance for distinguishing between device recalls and improvements. I won’t go into details, but it’s tough to avoid the conclusion that FDA now sees draft guidances and proposed rules as opening gambits in a negotiation.


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