CDRH Draft Plan for Abbreviated 510(k) Option Raises Questions

Regulatory NewsRegulatory News | 12 July 2018 |  By 

The Medical Imaging & Technology Alliance (MITA) and AdvaMed, among others, voiced concerns with how FDA’s Center for Devices Radiological Health (CDRH) intends to expand on the existing Abbreviated 510(k) program as described in a draft guidance from April.
The draft left commenters puzzled since agency officials had indicated the expanded program would allow for greater flexibility when the plans were first announced last year.

The industry groups commended CDRH for the attempt to identify new ways to reduce burden on industry. But the draft guidance ultimately under-delivered on the promises that had been made, according to comments.
“The benefit for using this program is unclear,” MITA Executive Director Patrick Hope wrote in a comment submitted to the draft guidance’s public docket, which closed on Wednesday.
Hope noted that review times continue to be 90 FDA days for both the traditional and abbreviated 510(k) programs. A “clearly stated reduction in review time” for the expanded abbreviated 510(k) program would be helpful, Hope said.
The format for a traditional 510(k) submission is also “very similar” to the format listed in the draft guidance for abbreviated submissions, Michael Morton, principal consultant at MC Morton Regulatory Consulting, noted in an interview with Focus.
Morton argued the traditional 510(k) pathway is one that allows for more flexibility because sponsors have the option of using side-by-side comparisons to existing devices, as well as declarations of conformity to FDA-recognized consensus standards.
Use of the “recognized consensus standards, and device-specific guidance documents is not limited to Abbreviated 510(k) submissions,” FDA final guidance on the 510(k) program states.
A goal in expanding the abbreviated program is to help sponsors that may be unclear on whether a device type would be deemed appropriate for the alternative option. FDA intends to publish and maintain a list on its website of the appropriate device types for participating in the expanded alternative program, according to the draft guidance.
Each device type would be “accompanied by the guidance documents that identify the performance criteria for each device type, as well as the testing methods recommended in the guidances where feasible, and any other relevant information,” the draft guidance states.
AdvaMed VP of Technology and Regulatory Affairs Ruey C. Dempsey wrote in a comment to FDA: “While we support the intent of this guidance to expand device clearance through conformance to applicable guidances, special controls, or standards, it is somewhat difficult to determine the impact of this effort—or to offer more substantive input without better understanding the device types that will be eligible to use this expanded pathway.”
Preparing additional device-specific guidance to encourage participation in the program for the appropriate device types is expected to be time-consuming and burdensome, according to comments. 
To avoid causing unnecessary burden on CDRH staff and to facilitate firms’ compliance with requirements in multiple jurisdictions, the groups encouraged CDRH to keep globally-recognized standards in mind in assessing performance criteria for each device type.
Other suggestions the groups made relate to a set definition for an “equivalent test methodology” and a mechanism for firms to propose including a device type on the list.
Comments: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff


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