Get ready for “increased product complexity and risk aversion” from the FDA. It’s top regulators, says regulatory attorney Mark DuVal, “disdain” the 510(k) clearance program and are intent on sweeping changes which, they hope, will modernize the device clearance system.
That’s DuVal’s prediction. After decades of representing medical device companies and having had his share of negotiations with the FDA, it’s a prediction worth noting.
DuVal walks a fine line. On one side he has to advocate for his medical device clients. On the other, he has to please FDA regulators for those clients. The life of a device company can hang in the balance. Just ask the folks at ReGen Biologics or CoAxia.
What will that more complex and risk averse fine line between device companies and the FDA look like in 2019?
On November 26, 2018, we got a hint when FDA Commissioner Scott Gottlieb, M.D. and his Center for Device and Radiological Health (CDRH) Director, Jeff Shuren, M.D. announced plans to formally propose a major overhaul of the 510(k) process. Eighty-two percent of all medical devices reach the market under the 510(k) pre-market notification rules of the FDA.
“Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies,” said a joint statement by Gottlieb and Shuren.
The duo is now seeking public feedback on whether predicates older than 10 years are still relevant and if the Agency should act to “advance the use of modern predicates.”
They gave the public until March 7, 2019 to comment.
DuVal Unplugged
DuVal didn’t wait—or hold back.
In a note to his clients on December 18, 2018, DuVal predicts there will be an attempt to create a new 510(k) program.
He noted Gottlieb and Shuren’s “firm belief” in the merits of the program, BUT said the program needs a “new framework.” He also reminds his readers of Shuren’s inaugural and failed attempt to rewrite the 510(k) program in 2009 when he asked the Institute of Medicine to propose recommendations to rewrite (or even abolish) the 510(k) program. That attempt was met with a huge industry counter-movement.
The framework now being considered would eliminate the use of predicates older than 10 years. The agency also wants to publish a list of newly cleared devices which use the older predicates. Essentially, says DuVal, the FDA wants to publicly “shame” the makers of those devices.
The Agency, writes DuVal, also wants to create a new, as yet undefined, alternative pathway to clearance.
“The Agency does not seem to realize that there is nothing wrong with older predicates and that the predicate family updates itself through innovation. FDA seems to want to involve itself in influencing the medical marketplace to make decisions about which devices to use or not.” Where does the agency get the authority to make these changes, he asks rhetorically.
“This seems to be a solution in search of a problem. Industry is fatigued keeping up with Dr. Shuren’s endless proposals to ‘update’ the 510(k) program over his tenure. It has caused endless and unnecessary turmoil.”
“The 510(k) program isn’t perfect, but it works, and everyone is familiar with it. It isn’t a race horse, it’s a plow horse. It isn’t fast or sexy, but it gets the job done.”
‘The problem is the FDA is getting increasingly academic and wants to change it either out of regulatory boredom, fiefdom building, or both. The one guy who really knows how to honor and apply the 510(k) program is Dr. Maisel, Director of the Office of Device Evaluation and Chief Scientist, CDRH.”
The industry, adds DuVal, needs to remind the FDA they are an administrative organization, not a legislative body. “If they want to make some of these changes, like the 510(k), they will have to propose them to the Congress.”
