Following Tuesday’s final guidance that established a new option for 510(k) clearance, a spokesperson from the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) highlighted next steps to implement the new Safety and Performance Based Pathway in 2019.
“Our next step is to develop an implementation plan to apply this Safety and Performance Based Pathway,” CDRH spokesperson Angela Stark told Focus
. “We encourage industry and other stakeholders to submit evidence-based suggestions on what the performance criteria should be for eligible device types.”
As part of the implementation plan, the agency will develop performance criteria for each device type deemed appropriate for the alternative option to demonstrating substantial equivalence. It intends to identify these criteria “by evaluating the criteria and performance of devices submitted in previous 510(k) submissions or by using existing consensus standards for a particular device type,” Stark said.
Stark also confirmed with Focus
that all CDRH’s existing premarket notification pathways, including for abbreviated, traditional and special 510(k) submissions, will remain unchanged and available to applicants. Submissions to the Safety and Performance Based Pathway will still be considered 510(k)s.
The new regulatory review pathway
is “intended to increase the options available to manufacturers of certain, well-understood device types to receive clearance of a 510(k),” Stark said. “It is optional and will not change existing review processes that are working for the FDA and manufacturers.”
In reaction to the final guidance, AdvaMed President and CEO Scott Whitaker told Focus
that “the medical technology industry has long maintained—as has FDA—that the 510(k) process is a vital part of the regulatory framework designed to provide patients timely access to safe and effective medical devices.” AdvaMed looks “forward to working with the agency on the process' continued evolution.”
The agency also intends to develop a string of new draft guidance documents throughout 2019 that will be specific to the device types considered appropriate for the new pathway.
“We will work to develop draft guidances that will be released for public comment in 2019 and will be implemented upon finalization,” Stark said. “FDA expects that once criteria are developed for a device type and announced through device-specific guidance, a submitter could use this pathway and demonstrate that its device meets the criteria.”
The idea for an expansion of CDRH’s Abbreviated 510(k) program was centered on providing additional
flexibility for eligible device types to seek 510(k) clearance through increased use of device performance criteria and voluntary consensus standards rather than direct comparison testing of predicate devices.
Michael Morton, principal consultant at MC Morton Regulatory Consulting, noted in an interview with Focus
that a challenge facing the push for greater use of the abbreviated 510(k) approach relates to the ability of standards development organizations to keep pace with the growing body of devices globally, as well as the agency’s ability to connect standards with device eligibility. This in turn could result in a disincentive or deterrent for device types without a corresponding consensus standard. Morton posed the question of whether device firms would be tied to traditional 510(k)s in lieu of FDA-listed product codes.
The agency committed to maintaining a list of eligible device types on a new webpage launched Tuesday, following the release of the 14-page final guidance document, that will include the pending guidances that will identify the established performance criteria for each type. “FDA-recognized consensus standards that have not been identified in FDA guidance for use in the Safety and Performance Based Pathway should not be used in this program,” the final guidance clarified.
Still, the push for greater use of consensus standards through the Safety and Performance Based Pathway coincides with the work the agency finalized
just last year in collaboration with International Medical Device Regulators Forum member countries on optimizing device standards for regulatory use.
"While we are still reviewing the details of FDA's final ‘Safety and Performance’ guidance, AdvaMed has been supportive of the abbreviated 510(k) program on which it's based, and we have encouraged the agency to make greater use of national and international consensus standards,” Whittaker added.