Shuren Proposes Ways to Address FDA's Flaws

FDA’s much-maligned regulatory program for medical devices is flawed and will have to undergo several changes. That's what CDRH director Jeffrey Shuren told the crowd at the Medical Device Manufacturers Association (MDMA) annual meeting in June. Shuren listed the following shortcomings:

These issues, Shuren said, have consistently surfaced in workshops, town-hall meetings, public dockets, and other communications from consumers, healthcare providers, and representatives of the device industry. They have also come up during internal CDRH reviews.

Shortly after taking charge at CDRH, Shuren recognized that there was a dearth of written procedures or guidances that could clarify expectations and encourage consistency in the review process.

“In the absence of guidance,” Shuren said, “expectations for material to be included in regulatory submissions were often simply passed down as ‘tribal law’ from reviewer to reviewer.”

Shuren attributed that breakdown to insufficient staff resources. Few workers had the capability to undertake the time-consuming task of drafting guidance documents. He indicated that the ultimate solution is to have a core staff of technical writers oversee and assist reviewers in drafting guidances.

In the meantime, he said seven new guidances are now in preparation, covering the following subjects:

Shuren acknowledged that, even in the best circumstances, developing and publishing guidances is a lengthy process. 

When it comes to the attention of reviewers that new information may be required of sponsors, a so-called “notice to industry” letter will be disseminated, instructing device makers to comply immediately rather than waiting for guidance. Shuren said such letters will be short notices of issues that will be clarified by later guidance. He said the letters are intended to reduce the number of submission cycles as new requirements are imposed.

Other initiatives focus on educating reviewers. A certification program will involve coursework and practicum for all newly hired reviewers, while an experimental learning program will give reviewers the chance to spend time with manufacturers and in medical facilities. The latter program is meant to impart real-world experience to reviewers, so that they are familiar with how the devices were developed and used in the field.

Shuren said CDRH is also developing an outside network of experts fluent in various areas of technology, to be employed when on-staff expertise is not available.

Finally, Shuren pointed out that more than half of regulatory submissions are faulty in some way. In many cases, sponsors fail to follow available guidance and fail to provide justification for doing so. Some sponsors even fail to offer performance data. “It’s a two-way street,” Shuren said. He noted that such lapses in submission quality do no favors for reviewers and unnecessarily lengthen review times.

Answering a question about the reason behind the high turnover rates among CDRH staff, Shuren blamed excessive workloads, especially among supervisors. He said that some supervisors manage as many as 27 reviewers.

Acknowledging that many CDRH employees flee for more lucrative offers from industry, Shuren said that others accept positions elsewhere in FDA, particularly with CDER, which can offer higher salaries for similar work.

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