FDA to modernize, finalize 510(k) clearance pathway for medical devices

The FDA has announced plans to modernize and finalize its 510(k) clearance pathway as part of a continuing effort to advance the review of safety and effectiveness of medical devices, according to a recent statement from FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health (CDRH).  

The officials noted the FDA does believe in the merits of the 42-year-old pre-market submission process which has established the framework for evaluating low- to moderate-risk medical devices substantially equivalent to a device already on the market. 

However, aspects of the pathway are outdated, and the changes are aimed to promote modern patient care and “reflect advances in technology, safety and the capabilities of a new generation of medical devices”, Gottlieb and Shuren wrote.  

In April, the FDA issued “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” as an initial effort to enhance programs and processes to assure the safety of medical devices.  

Instead of using a predicate device to conduct direct comparisons, the FDA will instead support devices of “substantial equivalence” based on data showing that the performance level of the new device meets or exceeds that of an appropriate predicate device, the statement read.

“The most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients,” according to the officials.  

The new approach will be named the “Safety and Performance Based Pathway." Through the new pathway, a company will have to demonstrate that a new device meets modern performance-based criteria established or recognized by the FDA and reflects current safety and performance technological principles of modern predicate devices, according to the release. 

“We’d like this efficient new pathway to eventually supplant the practice of manufacturers comparing their new device technologically to a specific, and sometimes old, predicate device,” the officials wrote.  

Nearly 20 percent of current 510(k)s are cleared based on a predicate device that is more than 10 years old—which the FDA noted doesn’t mean that products are unsafe necessarily but that some medical devices may not be continually improving in terms of technology, quality and safety.  

To promote the use of more recent predicates, the FDA’s CDRH is considering publishing online such predicates that are more than 10 years old. The move is part of a larger effort to drive sponsors to continually offer patients the most advanced technologies.  

In early 2019, the FDA intends to finalize its an alternative 510(k) clearance pathway and make it the primary pathway for devices eligible for 510(k) review.  

“Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices,” the officials wrote. “It’s vital that the FDA’s regulatory approach continues to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that sometimes accompany this progress.”