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FDA Official Promotes Third-Party Review Option

By Lori Luechtefeld

Medical device manufacturers preparing to file a 510(k) with the U.S. Food and Drug Administration (FDA) might want to consider the alternative of working through the agency’s third-party 510(k) review program, according to Marjorie Shulman with FDA’s Center for Devices and Radiological Health (CDRH).

“The third-party review program gives manufacturers the option of using accredited, non-federal organizations to review
510(k)s for low- and moderate-risk devices, in place of FDA’s review," said Shulman. The third-party review program, under which CDRH identifies accredited persons (APs) that are eligible to perform third-party reviews, is designed to provide manufacturers with faster marketing-clearance decisions, as well as improve the allocation of FDA’s limited resources.

Shulman, speaking on Monday to attendees of the MD&M West conference, said manufacturers should consider taking advantage of the third-party program because APs can provide more timely review of 510(k)s and are generally more accessible throughout the process. In addition, manufacturers that have 510(k)s reviewed by APs are not required to pay FDA user fees. “Many APs also have standards and foreign regulatory experience," Shulman adds.

However, the third-party review program is not appropriate for all 510(k) reviews, said Shulman. Manufacturers should think twice about employing the service of an AP when filing special 510(k) submissions, which typically are reviewed by FDA within 30 days. Manufacturers should also reconsider submitting complex, precedent-setting 510(k) submissions to a third-party, some of which may lack the relevant experience needed to evaluate the submission. Submissions for devices in which eligibility is uncertain—such as cases where clinical data may be required—are also instances in which manufacturers should proceed with traditional FDA reviews, said Shulman.

Manufacturers interested in the third-party review program can obtain more information on the process through FDA’s Web site at www.fda.gov/cdrh/thirdparty.