FDA’s Center for Devices Radiological Health (CDRH) intends to expand on the existing Abbreviated 510(k) program that was described in draft guidance in April. However, many companies such as Medical Imaging & Technology Alliance (MITA), AdvaMed, and others voiced their concern, reported RAPS.
Previously, officials indicated that the expanded program would allow for greater flexibility. However, the draft guidance ultimately under-delivered on the promises that had been made.
MITA Executive Director Patrick Hope said that, “the benefit for using this program is unclear.” Furthermore, Hope noted that review times continue to be 90 FDA days for both traditional and abbreviated 510(k) programs. He also noted that if there was a “clearly stated reduction in review time” for the expanded abbreviated 510(k) program would be helpful.2
Principal consultant at MC Morton Regulatory Consulting, Michael Morton highlighted in an interview with RAPS RegulatoryFocushow the format for the traditional 510(k) pathways is very similar to the format listed in the draft guidance. He argued that the traditional 510(k) pathway allows for more flexibility.
FDA final guidance on 510(k) program states, “recognized consensus standards, and device-specific guidance documents is not limited to Abbreviated 510(k) submissions.”1
One of the goals in expanding the abbreviated program is to assist sponsors who may be unclear on whether a device type could be eligible for alternative options. Along with the expansion, FDA intends to publish and maintain a list of appropriate device types on their company would be eligible for participating in the expanded alternative program.
The draft guidance states that each device would be “accompanied by the guidance documents that identify the performance criteria for each device type, as well as the testing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 guidance where feasible, and any other relevant information.”1
Adva Med VP of Technology and Regulatory Affairs Ruey C. Dempsey understands and supports the intent of the guidance but acknowledges that 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.”2
A variety of groups advise CDRH to keep globally-recognized standards in mind in assessing performance criteria for each device type.
Pearl Pathways’ experienced team guides startup and large device companies through the challenges of developing various types of medical devices. Learn how we can support the development, validation, design, and submission of your next device.
2https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-1387