Shuren: Most 510(k)s Now Clearing Refuse-to-Accept Bar with Ease

May 1, 2015

Devicemakers are doing a better job meeting FDA standards for 510(k) submissions, CDRH Director Jeffrey Shuren told an industry group Thursday.

In 2013 roughly 58 percent of device submissions were bounced back for failing to meet the detailed acceptance standards, Shuren told an FDA Town Hall session at the Medical Device Manufacturers Association’s annual meeting in Washington, D.C.

That rate has since fallen to 30 percent, and CDRH is establishing a pilot program to let reviewers accept imperfect submissions at their discretion, Shuren said.

Even better, a full 90 percent of submissions are approved or classified as approvable after two cycles, Shuren said. The most common hold-ups are GMP inspections and labeling concerns, and CDRH is looking at moving inspections earlier in the device review cycle to avoid approval delays, he added.

The device center also has seen success with a program allowing manufacturers to submit questions and receive written answers before a formal presubmission meeting, Shuren said. In some cases, companies have cancelled the meetings because their questions had been fully addressed in writing.

Turning to staff training, Shuren said the experiential learning program, which sends CDRH employees into the field to meet with devicemakers, has seen more than 560 CDRH employees visit 57 locations. The agency is looking for more manufacturers to participate.

The center director also noted a priority of speeding device trial approvals, including allowing devicemakers to apply for investigational device exemptions earlier in the development process. The median IDE review time has dropped to 30 days in 2015, from 442 days in 2010. And the center has approved 17 IDEs since the first of the year versus 10 at this point a year ago.

The expedited process is allowing U.S. device approvals to catch up with the rest of the world, Shuren said, noting the previous delay between European and U.S. approval could be as long as five years.

CDRH also is focusing on quality, the center chief said. For example, the agency recently set up a CAPA system, known as Feedback CDRH, where stakeholder complaints are collected and reviewed in a standardized manner. The result, Shuren said, is a customer satisfaction rate of 88 percent — better than the center’s target goal of 80 percent by June 2015.

The center has also been reviewing its traditional standards for evaluating device risk and is now placing a greater emphasis on patients’ willingness to tolerate some risk if there is a true benefit from the device.

CDRH staff members are now allowed to approve devices posing a greater possibility of risk so long as patients accept that, Shuren said. For example, some devices may be approved with an indication for use only with patients willing to tolerate the different risk profile.

Shuren added that forthcoming guidance will clarify benefit-risk considerations in device clinical trials.

Shuren also discussed the agency’s approach to regulating innovative technology, such as next-generation sequencing. Traditional diagnostics test for only one condition; modern DNA sequencing can check for as many as 3 million. To address that, CDRH is allowing manufacturers to submit results addressing the accuracy of next-generation sequencing tests based on only a subset of the data. One test for cystic fibrosis already has been approved in this way. — Elizabeth Orr