FDA seeks to modernize 510(k) clearance pathway for medical devices
The FDA published its final guidance Jan. 22 for ensuring medical devices meet “more modern safety and performance criteria” before being cleared through the agency’s 510(k) review process.
One of the goals of the guidance is to evaluate devices against more modern predicate devices, which are used for comparative testing to show that a new device is equally safe and effective.
“For appropriate device types, the Safety and Performance Based Pathway will ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent and well-validated safety and performance metrics,” FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, wrote in a statement.
“The benefit of this approach is that the pathway will benchmark modern technology against modern standards while at the same time offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products. We also believe this new approach may drive greater market competition to develop safer devices.”
According to the statement, the FDA will issue performance criteria for certain “well-understood” device types this year, with opportunities for public comment before those criteria are used in the new 501(k) pathway. The agency also announced it is taking public comments on other actions it could take to promote the development of safer, more effective 501(k) devices; whether it should consider making some older devices ineligible to be used as predicates; and whether it should make public a list of devices or manufacturers who rely on predicates that have been on the market beyond a certain number of years.
A docket for these comments was created Jan. 22 and will be open for 90 days.
“We believe firmly in the merits of the 510(k) process,” Gottlieb and Shuren wrote. “Thousands of devices are cleared through this process each year and countless thousands more patients benefit from these technologies. In taking these new steps today, we’re reaffirming our commitment to continually strengthening our review process, so that it can continue to serve and protect American patients well for years to come.”
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.