Shuren Says Expect Plenty of Guidance From Devices Center by End of Year

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By Joyce E. Cutler

SAN FRANCISCO—The Food and Drug Administration's Center for Devices and Radiological Health will issue more than a half-dozen pieces of guidance by the end of the year, the head of CDRH said Sept. 22.

Jeffrey Shuren, speaking to reporters following an agency “town hall” meeting, said, “We're shooting for early feasibility guidelines and types of clinical approval at the end of October.”

Shuren said at the meeting that the agency will put out “in the next few weeks” a draft guidance on the de novo process for moderate-risk devices. “We think that will get de novo back on track,” he said, urging interested parties to make comments on the draft. Under de novo, FDA streamlines the review of new, low-risk medical devices that are not substantially equivalent to a marketed predicate device and would otherwise be subject to the more rigorous premarket approval process.

Based on feedback, the agency will make changes, “but we consider that a high priority, too,” Shuren said.

On Sept. 30, FDA announced a draft guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation), with a 60-day comment period (docket number FDA-2011-D-0689) (see related item).

Also before the end of October, CDRH will release a policy on early feasibility studies “for circumstances where they can start earlier, and opportunities where you to make changes to the device without having to go back to the FDA first,” Shuren said to applause at the meeting.

Other issues to be addressed include broader guidance for clinical data on the 510(k) premarket notification process; presubmission meetings; factors in approval decisions; standard operating procedures for networks of experts; updating processes for appeals outside of the committees; and use of standards, he told reporters, noting that CDRH is engaged in more than 120 standards development groups.

Shuren's speech came as the agency is considering ways to revamp the 510(k) process. At a recent public event in the Washington area, representatives from the medical devices industry told FDA that the 510(k) process can be improved and does not need to be abandoned. Stakeholders said at that meeting that a July 29 report from the Institute of Medicine, which recommended scrapping the 510(k) process, was flawed (5 MELR 563, 9/21/11).

The agency also is set to publish Oct. 4 in the Federal Register a notice containing the website where FDA will post a list of guidance documents CDRH is considering for development.


More information on FDA's regulation of devices is at http://www.fda.gov/MedicalDevices/default.htm .

The de novo guidance issued Sept. 30 is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm .