Device manufacturers have two months to help inform US Food and Drug Administration (FDA) draft guidance on its Special 510(k) Program.
The 32-page draft guidance for industry and FDA staff is intended to update the policies set forth when the program was launched
in 1998. At the time, modifications to the intended use of a device or any labeling changes were deemed inappropriate for special 510(k) submissions.
“We are proposing to evaluate whether design and labeling changes can be reviewed under a special 510(k) by focusing on whether the method(s) to evaluate change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format,” the agency said. Submissions will remain subject to other 510(k) content requirements, such as the results from verification and validation of design or labeling changes, under the draft policies.
The proposed device eligibility expansion is intended to aid agency review staff meet a goal set as part of the latest authorization of the Medical Device User Fee Act to reduce the average total time to decision for 510(k) submissions to 108 calendar days by FY 2022.
The Special 510(k) Program “offers a truncated review process in a 510(k) submission” though it is only an option for modified devices that have already obtained FDA clearance, Michael Morton, principal consultant at MC Morton Regulatory Consulting, told Focus
The incentive to choose this option relates to the FDA review time of no more than 30 days of receipt consistent with the least burdensome principles of the FD&C Act
. In contrast, 510(k)s submitted under the Traditional 510(k) Program are to be reviewed within 90 days. Special 510(k)s also do not require complete test reports, as opposed to traditional 510(k) submissions.
The fact that the Abbreviated 510(k) Program, which FDA is also planning
to expand with the goal of providing greater flexibility to manufacturers of certain devices, has the same FDA review clock—90 days—created some confusion
around the intended benefits of an expansion.
To demonstrate substantial equivalence (SE) of a modified medical device to one that has been released for commercial distribution in the US, the draft guidance points to an updated flow chart for the decision-making process in determining whether a special 510(k) is appropriate.
Considerations outlined in a Q&A format provide further clarification. These relate to whether the change is to the manufacturer’s own device, testing is needed to support an SE determination and well-established method to evaluate change already exists, among other considerations.
The circumstances in which FDA does not believe that a special 510(k) would be appropriate are fleshed out in the document as well, including “when a QS [Quality System] inspection has resulted in the issuance of a violative inspection report under review in the 510(k),” FDA said.
If agency review staff do not agree with a case made by a submitter that its proposed device modification can be evaluated via a special 510(k), FDA intends to convert the submission to a traditional 510(k). The conversion process “can result in delayed review,” the agency cautioned.
Earlier this month, the agency announced
plans to launch a pilot next year of yet another regulatory review pathway for 510(k) submissions dubbed the Quality in 510(k) (“Quik”) Review Program. This pathway is also intended to expedite submissions for well-understand devices.
FDA Commissioner Scott Gottlieb said in a Twitter thread on Thursday that the agency intends to pilot the expanded Special 510(k) Program “in coming days to test modifications on eligibility.”
The Special 510(k) Program: Draft Guidance for Industry and Food and Drug Administration Staff