The Institute of Medicine’s report on the FDA’s 510(k) clearance process for medical devices falls so far out of the scope of the questions it was meant to answer that it’s essentially meaningless, med-tech industry reps told the agency during negotiations over re-authorizing the Medical Device User Fee & Modernization Act.
Institute of Medicine
It certainly wasn’t a slow summer for the medical device industry. Over the past three months we’ve seen a bid for the elimination of the FDA’s workhorse clearance program, renewed interest from the private sector (and the return of the leveraged buyout), a well-intention hacker taking aim at medical devices – not to mention layoffs among some of the largest of the large-cap players and a concerted move East in search of greener pastures.
Here’s a look back at the top five MassDevice stories of the summer, according to our readers.
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The Institute of Medicine was right to dub the FDA’s 510(k) medical device program unfixable, at least according to the New England Journal of Medicine.
The process of using existing or "predicate" devices as the basis for evaluating the safety and effectiveness of a new device is "untenable," according to an editorial in the respected medical journal. The authors recommend that the FDA immediately stop using the protocol for Class III devices – considered to pose the highest potential risks to patients.
The Institute of Medicine report on medical device regulation released two weeks ago called for scrapping the 510(k) process that allows for market entry of new devices if they’re shown to be “substantially equivalent” to already marketed devices. In a Perspective in today’s New England Journal of Medicine, committee members David R. Challoner, M.D. of the University of Florida and William W. Vodra, J.D., an attorney at Arnold & Porter, reiterated the reasoning of the report:
FDA Center for Devices & Radiological Health director Dr. Jeffrey Shuren asked med-tech officials at a town hall meeting in St. Paul, Minn. to pitch in with ways to help improve the agency’s medical device review fast-track, reassuring industry that the 510(k) process isn’t going anywhere.
"I don’t think we should eliminate [the 510(k)] process in its entirety. It does have a role, it needs some fine-tuning," he said.
Lawmakers from the North Star State are falling in line to oppose one of the key findings of the Institute of Medicine’s recent report on the FDA’s 510(k) premarket notification.
Sens Amy Kloubechar (D-Minn.), Al Franken (D-Minn.) and Rep. Erik Paulsen (R-Minn) issued a joint statement saying that they rejected the IOM’s finding that the FDA should scrap the 510(k) program altogether and start anew.
MASSDEVICE ON CALL — A Federal Circuit court ruled that corporations can patent genes, overturning a lower court decision, but lawyers predict the fight isn’t over yet.
Federal judges ruled 2 to 1 that Myriad Genetics Inc. of Salt Lake City, Utah, was entitled to two breast cancer gene patents used to predict whether women have a higher risk of developing breast cancer or ovarian cancer.
The U.S. Food & Drug Administration will open the public record on the 22-month $1.3 million study of its 510(k) program by the Institute of Medicine that called for the elimination of the program by which more than 4,000 medical devices are cleared for market.
The FDA said it is seeking public comment on the 200-plus page report, which contains several non-binding recommendations for the agency and its 510(k) premarket notification program.
MASSDEVICE ON CALL — The Institute of Medicine’s recommendations for the FDA’s medical device application fast-track are a nonstarter for the agency and for the industry.
The IOM released findings from its year-long audit of the 510(k) review process on Friday, concluding that the only way to fix the process was to replace it entirely.
After the release of the Institute of Medicine report this morning, we now know why FDA officials have spent the last few weeks putting some distance between the agency and the findings of the report; they just can’t afford to fight a losing battle right now.
As part of eight recommendations it made to the agency, the IOM called for the FDA to scrap the program by which the lion’s share of medical devices are cleared for market.