FDA takes new steps to modernize 510(k) clearance pathway for medical devices

Today, the FDA took two new steps to modernize and finalize its 510(k) clearance pathway, following the agency’s November announcement regarding a larger effort to advance the review of safety and effectiveness of medical devices.

“We believe firmly in the merits of the 510(k) process...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,” wrote FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health (CDRH), in a recent statement.  

The agency posted, on Jan. 22, a final guidance establishing the framework for the Safety and Performance Based Pathway, entitled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria”.  

Under the Safety and Performance Based Pathway, a medical device manufacturer would have the option to show that a new device meets FDA performance criteria by demonstrating current technological principles and the safety and performance of modern predicate devices.  

Gottlieb and Shuren noted this new approach may drive greater competition among companies to develop devices that are safer than those already on the market and ensure patients have timely access to them.  

The FDA also plans to hold a webinar to communicate with stakeholders and explain how the Safety and Performance Based Pathway will be implemented and is welcoming suggestions on what performance criteria should be for various device types.  

“This year, we’ll build on today’s final guidance by establishing safety and performance criteria for certain well-understood device types,” Gottlieb and Shuren added. “We’ll issue these criteria through guidance, which includes an opportunity for public comment prior to using them under the new pathway.” 

The FDA also issued a notice and opened a public docket requesting public comment for approaches to drive sponsors to offer patients the latest technological innovations.  

The FDA is requesting feedback on the following topics (as were previously mentioned in November): 

  • Should the FDA make public a list of devices or manufacturers who make technologies that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time? 
  • Should the FDA consider using other criteria to inform our point of reference? 
  • Are there other actions we should take to promote the use of more modern predicates? 
  • Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates? 

The docket will be open for responses to the following questions for the next 90 days, according to the statement.