FDA commissioner Margaret Hamburg, MD, opened the first day of the FDA Regulatory and Compliance Symposium with a broad address on the agency's priorities and upcoming developments, and she confirmed that the new leadership at FDA has misgivings about the concept of the predicate device that undergirds the 510(k) program.

Hamburg said the agency will at the very least examine "the process itself and how it is implemented," but also remarked that the agency "can bring a bit more rigor to the implementation." All the same, she also posed the question of "whether the framework is one we can live with."

Hamburg's remarks follow by less than a week the report by senior FDA officials on the Menaflex 510(k), which has become something of a poster child for criticisms of the program (Medical Device Daily, Sept. 25, 2009). Deputy commissioner Joshua Sharfstein, MD, noted in a conference call last week that the review process for the Menaflex, made by ReGen Biologics (Franklin Lakes, New Jersey), was compromised, even by FDA reviewers in addition to members of Congress. The Menaflex application also dragged two former FDA officials into the controversy, former commissioner Andrew von Eschenbach, MD, and Dan Schultz, MD, who held the post of director of the Center for Devices and Radiological Health until recently.

"The complexity of medical devices ... has changed dramatically" since the passage of the Medical Device Amendments of 1976 that gave rise to the 510(k) program, Hamburg noted, adding that FDA is "looking to the IOM to help us examine and sort through" the related issues and "to identify critical next steps." She declined to discuss what sort of changes the agency could impose without a statutory change, and noted that IOM will soon assemble a committee to take up this task.

Regarding her new job, Hamburg remarked, "I did not fully understand or appreciate the vast scope of the agency's mission," she said, describing it as "one of the most intense and enriching experiences" of her career. She said, "a few friends and family members thought I was crazy" to take the job, given that FDA typically receives some pretty brusque treatment in the media and is regularly "battered on Capitol Hill."

Hamburg said the agency is working to "streamline our regulatory procedures," but argued that "regulatory science ... must also evolve," a requirement induced by evolving technology. On the other hand, she also asserted that the agency cannot have "only a scrawny investment" compared to the huge investments in regulated products, likening the imbalance to a rower in a boat whose arms are not evenly equipped with muscle tissue. Hamburg said that such a rower will soon be "going around in circles."

Hamburg also noted that she is "impressed with the commitment to compliance" demonstrated by some parts of industry, adding that the agency has "a responsibility to articulate our expectations" clearly.

All the same, she said, "a key part is effective enforcement," and she warned that companies "must have a realistic expectation ... if they fail to act, we will." Hamburg said FDA will "use meaningful penalties" to shape behavior and she added, "FDA must be visible" and "must show industry and consumers that we're on the job." She argued that the agency "must publicize that widely and effectively."

— Mark McCarty, Washington Editor