- The FDA is updating its voluntary 510(k) approval process to take into account growing medical device connectivity and interoperability, the agency announced Nov. 26.
The FDA explained that the 510(k)-approval process, which dates from 1976, needs to be modernized to accommodate advances in medical device technology and ensure that the devices meet more modern safety and performance criteria. The 510(k) pathway is used for approving low-to-moderate risk devices to speed the approval process.
Using the 510(k) pathway, manufacturers rely on comparative testing against predicate devices—devices already on the market—to show that a new device is as safe and effective as the predicate device.
As part of the modernization effort, the FDA plans to finalize guidance in early 2019 to establish an alternative 510(k) pathway that enables manufacturers of “certain well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products.”
The changes were first outlined in the draft guidance issued by the FDA in April of this year.
The agency said that nearly 20 percent of current 510(k) approvals are based on predicate devices that are more than 10 years old, a process that could be holding back medical device innovation.
The FDA is mulling publicizing devices or manufacturers who make technologies that rely on predicates that are more than 10 years old. The agency is also evaluating whether other criteria should be included in the agency’s point of reference and whether there are actions it should take to push the use of more modern predicates. It plans to ask for public feedback on these issues.
“We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes,” the agency said.
FDA said that 510(k) is the most commonly used premarket review process. Last year, the FDA’s Center for Devices and Radiological Health (CDRH) cleared 3,173 devices through the 510(k) pathway, which constituted 82 percent of all devices cleared or approved.
As part of the update, the agency is planning on renaming the 510(k) program the Safety and Performance Based Pathway to highlight a focus on improving safety and performance of new devices. “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 agency said.
In addition, the FDA is taking steps to promote greater transparency in the device approval process and better post-market surveillance.
“After careful review of our ability to impose special controls to better protect patients, we believe that more streamlined processes would improve FDA’s ability to implement new special controls to address safety concerns more quickly, as well as to up-classify a device type, where appropriate, in response to a safety concern,” FDA said.
The agency’s efforts in updating the 510(k) pathway complements its work on its National Evaluation System for Health Technology (NEST) initiative, which is designed to generate evidence across the total product lifecycle of medical devices by using real-world evidence and applying advanced data analytics.
Earlier in the month, FDA announced the launch of pilot studies to demonstrate how NEST would be implemented and the allocation of additional $3 million in funding for the NEST coordinating center in September.
These initiatives are all part of the agency’s broader plan, as laid out in its Medical Device Safety Action Plan, to improve medical device security across the board, with the ultimate goal of “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”