In the world of diagnostic and therapeutic devices, 2011 has already been a busy year, but a third of the year remains. There are still numerous developments that will trigger cheer and jeers, depending on where you sit.
This is not an exhaustive list of things that could arise in the last half of this year, but these are all pretty big, and a lot of people will be watching carefully.
FDA meeting on IOM 510(k) report: FDA recently invited all interested parties to talk about the recommendations made recently by the Institute of Medicine regarding the 510(k) device clearance process. Live attendance at the IOM announcement was meager, but this meeting will not want attendance because this time, the Big Kahuna (FDA) is the host rather than a group consisting almost entirely of med-tech virgins with PhDs.
FDA declared it will not pull the plug on the 510(k) program, but the brashness of the IOM recommendations suggest that the agency's managers will try to roll out some of the more sweeping ideas turned in by the agency's 510(k) study group at the beginning of the year. Among these are expanded power to rescind 510(k)s and the imposition of a GHTF-like scheme of four device classes by splitting class II devices into subclasses a and b.
Industry has rallied a lot of voices on Capitol Hill about what's going on, so this Sept. 16 meeting could devolve into so much prattle about the under-utilization of the de novo process. In that event, those who cannot attend might be glad they missed this meeting.
Patent Reform legislation: I promise you, it only seems like your kids went from grade school to grad school since this latest patent reform push commenced.
To some, the current pair of bills have all the appeal of rotten kimchi (I know: Who can tell when kimchi's rotten, right?) The House bill plays games with fee diversion and the Senate seems likely to take an up-or-down vote on the House bill.
If I had to bet it all, I'd bet the Senate will hold it's collective nose and gulp down this rancid mess because it's too late to start all over and nobody wants to go home having bungled it yet again.
The beauty of the House bill? We get to continue criticizing the latest Congress for being one of the worst sausage factories in the history of American national governance. When you consider what went on in the days of Andrew Jackson? That's saying a lot.
Edwards, FDA announce handshake on Sapien PMA: Will FDA hold its ground on two post-approval studies, one of which is a hypothesis-driven study of up to 1,000 patients? If so, will Edwards Lifesciences (Irvine, California) cave in? I guess FDA's Bram Zuckerman, MD, doesn't have to worry about it, but a truly first-of-a-kind cardiovascular device may end up running up a tab of something like $200 million if this keeps up.
Device user fee negotiations: It's tough to see the next five-year fee schedule not going up given the shrinking FDA budget, but it's also tough to see industry not demanding a LOT more accountability on device reviews. Do not expect faster turn-around times, but user fees for large firms will have to jump a pretty decent penny if industry wants 510(k)s and PMAs to turn around on the current time lines.
Prometheus v. Mayo at SCOTUS: This case won't arrive at the Supreme Court until October, so no decision will be forthcoming 'til 2012. Still, the questions from the bench in Bilski gave legal analysts everything they needed to forecast the outcome there. Justices Breyer, Ginsburg, Kagan and Sotomayor may find for Mayo, but Alito, Roberts Scalia, and Thomas almost certainly will not. Justice Kennedy, what say ye?