Medical Device Daily Washington Editor

The Center for Devices and Radiological Health (CDRH) unveiled its Medical Device Innovation Initiative yesterday to substantial fanfare, but the downside of the idea became apparent before the conference call had ended, namely that while the Center for Devices and Radiological Health will open up a fast-track for high-priority medical devices, CDRH will enjoy no additional resources to keep other, lesser-priority devices moving through the premarket pipeline.

Jeff Shuren, MD, the director of CDRH, made note of the recent report by PwC (New York) about the leadership in device innovation enjoyed by the U.S., and he remarked that the American leadership in med-tech "didn't happen by chance." He said the U.S. economy enjoys "obvious economic benefits" as well as benefits for patients as a result of that leadership, but he echoed remarks by others about the tenuousness of that leadership when he said the U.S. "won't remain the world's leader for long" without innovative oversight.

Shuren hinted at the possibility of a fast-track for such devices at a recent appearance at the American Enterprise Institute (AEI; Washington), saying at the time that FDA's interest was in devices that offer "the biggest bang for the buck" in terms of public health. At the time, law professor Ralph Hall of the University of Minnesota (Minneapolis) raised the question of "who decides what is innovation?"

Shuren noted that a number of ideas are embodied in the innovation program, remarking, "the most exciting is our proposal to establish" an expedited review program "to target unmet medical needs." To that end, Shuren said CDRH would "commit time and resources much earlier in product development" and will "choose and monitor qualified" applications via the CDRH science council, headed up by electrophysiologist Bill Maisel, MD, who formerly chaired the circulatory systems advisory committee.

The nuts and bolts of the innovation program, Shuren said, is that CDRH would "assign a case manager" for each product "and establish a primary review group" to help each application along. Within 120 days from acceptance of such an application, CDRH reviewers "will develop a memorandum . . . that describes a road map" for assessment and review of the application.

"The key features . . . will be resolving" safety and efficacy issues early in the process, Shuren remarked, noting that clinical trial protocols will be developed jointly by the sponsor and CRDH staff. "By front-loading our resources, we can cut the time it takes" to get these high-priority devices to market.

Shuren hinted at this notion early last year at the annual meeting of the Medical Device Manufacturers Association (MDMA; Washington), saying at the time that CDRH was "setting up a council on medical device innovation," but when asked by Medical Device Daily at the time whether the agency would face criticism for any perceived lowering of regulatory standards for favored products, he said "we are not going to change the standard to come to market" for devices that FDA bumps to the front of the device application queue (MDD, May 27, 2010). He echoed that theme on yesterday's conference call as well, noting that any priority device applications "must still adhere to the regulatory standards."

The first application to go through the expedited review mechanism is sponsored by the Defense Advanced Research Projects Agency (DARPA), part of the Department of Defense, which is working on an artificial hand and lower arm that closely replicates the functionality of the human hand, but which requires that a processor chip be implanted in the human brain in order to tie the device into the user's central nervous system.

DARPA's Geoffrey Ling, MD, noted that the application is the product of DARPA's Revolutionizing Prosthetics program, describing the degree of articulation of fingers and opposability of the thumb as "a major [engineering] achievement." However, Ling acknowledged that DARPA still must "develop and place that chip on the surface of the brain . . . so that the patient has to only think about the arm."

"If we can achieve this . . . think of the other technologies that will soon follow," Ling urged, adding that the technologies in question are "only four years old." He also noted that the arm "is ready to go," but added that clinical trials for the microprocessor interface will likely commence enrollment within six months.

As for the other parts of the initiative, Shuren noted that CDRH will work to establish a "robust research infrastructure in this country" for regulatory science, including an initiative to "creat[e] a voluntary third-party certification program for medical device test centers." He said FDA will recruit universities and others "in a competitive way" that will provide industry with a resource for testing and assessing so that "we can find and fix problems earlier." Shuren also said CDRH will work to develop a core curriculum for college degree programs in regulatory science.

Shuren said the initiative also includes some effort to clear up the issue of what sort of clinical data gathered from outside the U.S. (OUS) might be acceptable in FDA's eyes. He said the agency will offer "clear guidance on how sponsors can best leverage data and research" from OUS sources, although he offered no anticipated date for publication.

As for the expected impact on device application turn-around goals, Shuren remarked, "making a significant investment in the Innovation Initiative is a luxury we cannot afford," but "we can lay the foundation for the new paradigm" and "take just a handful" of applications.

In a Feb. 8 statement, Steve Ubl, President/CEO of the Advanced Medical Technology Association (AdvaMed; Washington) said the association "commends FDA for its recognition of the vital role an efficient and predictable regulatory system plays in ensuring" availability of novel medical technology in the U.S., but that it is "critical that FDA maintain its focus on bringing greater speed and consistency to the current review process." Ubl also noted that AdvaMed will "review the specifics" of the initiative and that the association "look[s] forward to discussing the details with the agency."

Mark Leahey, president/CEO of MDMA, said in a Feb. 8 statement, "we commend FDA for recognizing the powerful contributions medical technologies have [made] in improving patient care and the quality of life," adding that MDMA sees as critical the need to "work together to ensure that the countless other therapies attempting to navigate FDA are provided a reasonable, timely and predictable regulatory pathway."

Mark McCarty, 703-268-5690

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