The FDA’s less-stringent 510(k) medical device review pathway is no stranger to criticism, but it has at least 1 fan – Hyman, Phelps & McNamara attorney Jeffrey Shapiro.
Shapiro defended the fast-track review pathway, which doesn’t usually require that medical device companies submit to U.S. clinical trials in order to demonstrate safety and efficacy, and he expects that the 510(k) system will "be around for a long time."
In a presentation prepared for last month’s Petrie Flom conference at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Shapiro shared why he believes the 510(k) pathway is strong and getting stronger all the time.
"Taken as a whole, the 510(k) program has proven adaptable to a wide variety of devices, and has allowed meaningful premarket review while fostering robust technological innovation," Shapiro wrote in an analysis published in April. "Under the 510(k) program, the device industry has flourished and allowed for increasingly safer and more beneficial device technology, thus providing a practical demonstration that the 510(k) program is working well."
The 510(k) wasn’t so favorably characterized by the Institute of Medicine, which in 2011 recommended that the FDA scrap the program altogether. The non-binding IOM analysis didn’t make many waves at the FDA, which seemed to largely brush the report aside, but it certainly resounded with patient safety advocacy groups as well as with the editors of the New England Journal of Medicine.
A ProPublica report issued earlier this year covered "4 medical implants that escaped FDA scrutiny," highlighting that certain medical implants, such as metal hip replacement systems and surgical mesh, have resulted in major recalls after having zipped through the 510(k) process as being "substantially equivalent" to other existing technologies.
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 the NEJM editorial published in the wake of the IOM report. The authors recommend that the FDA immediately stop using the protocol for Class III devices – considered to pose the highest potential risks to patients.
"As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness," wrote NEJM executive editor Dr. Gregory Curfman and Dr. Rita Redberg, editor of the Archives of Internal Medicine. "The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now outdated."
Shapiro maintained that the 510(k) program, although certainly flawed, is nonetheless a strong program that could do with some updates rather than a wholesale overhaul.
"Certainly, there can be improvements," he wrote, noting that the program needs more transparency in particular, but the program remains a strong foundation for evaluating less-risky devices.
Shapiro took issue with the IOM report, writing in his presentation that the call to kill the 510(k) program was "ill considered." The report failed to cite any problems with the program that aren’t fixable, Shapiro said, admitting that the program has room for improvement. He further criticized the IOM’s assessment as "a misplaced theoretical concern underpinned by a flawed legal analysis," rather than a practical assessment based on real-world outcomes of the 510(k) program. Indeed, the IOM admitted in its report that its recommendations weren’t in response to any sort of "crisis" among medical devices wrongly admitted to the U.S. market, Shapiro noted.
The IOM, and some of its sympathizers, argued that the more than 35-year-old 510(k) process is ill-equipped to manage the varied and vast medical device landscape of today, but Shapiro argued that the age of the program was among its hidden strengths.
"The purpose of premarket review is to predict or characterize in advance the likely clinical performance of a device, in order to avoid unexpected adverse consequences," he wrote. "Now that 37 years have passed, the cohort of Class II devices have a long history of clinical use. They are generally well characterized as to their expected behavior. Further, their technology has been improved substantially over the years as would be expected. And regulations requiring reporting to FDA of adverse events, malfunctions and recalls have been in place for decades."
