Most of the changes announced today by the Center for Devices and Radiological Health to the 510(k) pre-market notification program for medical devices are favorable to the device industry.
That industry’s made a long practice of advocating for more clarity in the 510(k) process while insisting that there’s nothing fundamentally wrong with the program — by which more than 3,000 medical devices are brought to the U.S. market every year.
With today’s announcement, FDA officials agreed, mostly. Yes, they say they made several changes that reflect a more transparent, reactive and ultimately smarter FDA. You’ll find few people in the medical device industry who would oppose those moves.
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The agency’s also deferred the more controversial elements of its proposal — including a definition of its rescission authority (it already has the power and uses it) and the creation of a new device classification — that had earned nearly universal opposition from the industry.
CDRH chief Dr. Jeffrey Shuren said the agency would wait for a pending Institute of Medicine report on the 510(k) program before issuing its final judgment. Part of the reason to put the decision off was due to an onslaught of public comments, he added.
“Given the comments, we recognized that implementing some of those changes will be problematic,” he told reporters. “This gives us the time to move forward and to take measured steps.”
That delay could prove costly to the agency’s plans for the kind of structural makeover of the 510(k) system the FDA hinted at back in Sept. 2009. With Republicans at the fore on Capitol Hill, the respite gives the med-tech sector better odds.
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The medical device industry has been successful in cobbling together bi-partisan support on the Hill for its fight against radical changes to the 510(k) program. Last year, 15 U.S. senators and 12 House members wrote to FDA chief Dr. Margaret Hamburg to ask that the agency act cautiously. Signees of the October 2010 letter included Rep. Joseph Pitts (R-Pa.), now chairman of the Health sub-committee of the House Energy and Commerce Committee, which has budget authority over the watchdog agency.
Medical device industry allies are also stationed in key positions in the House power structure, including Brett Loper, who left a job as AdvaMed’s lead lobbyist to join House Speaker John Boehner’s (R-Ohio) staff as policy director, giving the industry an ear in one of the highest offices in the land.
Washington is more preoccupied with machinations over Republican efforts to repeal the Patient Protection and Affordable Care Act. But once that’s resolved one way or the other, or maybe even before, industry will still have the better part of six months to pick away at the 510(k) issue and another, related pet peeve: The FDA’s Medical Device User Fee program’s re-authorization is on the Congressional docket this year.
Shuren and the rest of his reform-minded staff might wind up regretting the decision to punt instead of ramming it across the line.
Related articles
- New FDA 510(k) medical device reviews will now be ‘smarter’ (medcitynews.com)
- FDA 510(k) reaction: Center for Devices and Radiological Health (medcitynews.com)
- 510(k) reaction: The trade group (medcitynews.com)
- FDA 510(k) reaction: The med-tech giant (medcitynews.com)
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
