The Center for Devices and Radiological Health's strategic vision for the next five years will replace the linear premarket/postmarket approach to device regulation with a more holistic program.

The centerpiece of the new strategic vision is the "total product life-cycle" model (TPLC), center Director David Feigal explained at an Oct. 18 press briefing in Rockville, Maryland. Under the TPLC model, CDRH hopes to refine its role in the multiple stages of device development: concept, prototype, preclinical, clinical, manufacturing, marketing, commercial use and obsolescence.

"We want to work with manufacturers and with industry to understand better the business cycles and how to measure our impact on that, not just whether we are predictable in the 510(k) communications," Feigal explained. Through the collection of "meaningful metrics," the center will assess whether its regulatory activities match the needs of the device industry.

For example, the CDRH director noted that the agency is not only interested in meeting the statutory requirements for premarket review, but also in looking "at whether the product made it to market in a predictable way."

"The important thing about devices is their rapid development cycles," Feigal commented. "In many categories of devices, the average lifespan of a product, including its market time, is eighteen months and there are some...replaced every six months."

CDRH may begin to tailor its policies toward the short product life cycles of devices. For example, certain postmarket studies are often rendered obsolete because the study endpoints are not met prior to the release of the next generation of the device.

Feigal questioned the wisdom of demanding "postmarket requirements for a product that is coming off the market in a planned fashion in six months," noting that "if it is a clinical study, you are not even going to launch [it] before the product is gone."

As an alternative to the current postmarket model, the center may need to look across product generations, Feigal suggested. "Instead of requiring a postmarket study for this product, we'd like to see this issue addressed in your premarket study for the next one."

Because product cycles are so short, the center may also be advised to evaluate products through multi-generational applications, Feigal suggested. Currently, the center employs a model whereby each product and each application "stands on its own, "he observed.

"One of the things that we are very interested in doing is getting discussions with industry [representatives] about how they manage their multigenerational programs and how they leverage the information from one [generation] to the next, "Feigal indicated.

By emphasizing the unique nature of the device life cycle, the new strategic vision appears to contrast strikingly the Temple report, which in 1993 indicated that the center should impose a drug-type model for premarket device regulation.

Feigal hopes to implement the vision through relatively broad pilots or "vanguards." Feigal emphasized that the new initiatives under the plan would not divert attention from meeting the center's premarket review goals.

"We ought to identify four or five vanguard areas," he proposed, noting that pilots optimally could be applied across a whole branch. Staff will then "have to sort of scale the work to their entire workload," he noted.

One goal of the initiatives will be to increase cooperation between divisions within the center and to integrate the center's activities with those of other federal agencies. In general, the FDA topsider called for premarket reviewers to utilize the "tremendous resources" within the center and to "make sure that the best knowledge in the center gets applied."

Noting that it is impossible for FDA to meet its manufacturer inspection requirements, Feigal also suggested that CDRH may consider a random sampling approach. While manufacturers likely would not experience a difference in inspection policies, random sampling would allow CDRH to better assess patterns in the device industry. Sampling would allow the agency to "do year to year planning and tracking and trending," as well as to provide report cards on the status of the industry, he asserted.

Noting that the strategic vision is still in its initial phases, Feigal invited stakeholders to participate in the development of specific policies.

CDRH's "Strategic Vision" Captures Unique Device Industry Landscape

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