Congress Should Revamp 510(k) Process: Opinion
Congress should use the upcoming Cures 2.0 bill draft and the reauthorization of the medical device user fee program to effect meaningful change to the 510(k) clearance process, such as revamping methods used to classify risk, according to an opinion piece appearing online on Statnews.com. The piece was authored by Yale Medical School professor Harlan M. Krumholz and Harvard Medical School student Kushal T. Kadakia.
The authors point to earlier recommendations to reform the 510(k) process by the Institute of Medicine (IoM) and its 2011 landmark report. “While some of the recommendations have made their way into policy, others, like reform of the 510(k) pathway, have not,” they write. “This pathway allows devices to be made available for use with limited to no clinical evidence if manufacturers can demonstrate their product is ‘substantially equivalent’ to an existing, approved device.”
The IoM report on the 510(k) process recommended that the agency scrap the program entirely (see earlier story) and design a new regulatory framework for Class 2 devices that is not based on “substantial equivalence” — rather on an “integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” At the time, CDRH director Jeffrey Shuren dismissed the recommendation, saying: “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.” Both FDA and the report noted that a new regulatory pathway would require Congressional interaction and legislation.
To illustrate the problem with the 510(k) program, Krumholz and Kadakia now cite their recently published an analysis of Penumbra’s Jet 7 Xtra Flex catheter, which was recalled earlier this year due to its potentially becoming susceptible to distal tip damage during use. The device is intended for use to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke.
The JET 7 was cleared in 2007, and the agency subsequently cleared nine modifications to the device. The authors contend that so many modifications to any device can eventually “transform the balance of risks and benefits and cause more harm than good... Of these nine next-generation devices, only six reported new animal data and only one reported new clinical data.” They also express concern about “clearing present-day medical devices based on evidence generated many years earlier — a phenomenon known as predicate creep — (that) can lead to risks slipping through the cracks. In the case of JET 7, the consequences became apparent only after the FDA cleared the device for use, with physicians filing more than 200 adverse event reports about the device — including 14 deaths — within its first year of use.”
Medical device innovation today requires a regulatory system that is “appropriately calibrated to the risks these products can pose to patients,” the authors conclude. “Policymakers should mark the 10th anniversary of the IoM report by seizing the moment and implementing long-overdue reforms to advance device safety while preserving innovation for the benefits of patients everywhere.”