FDA leader says agency must update clearance process for medical devices

WASHINGTON, D.C. — As the medical device and pharmaceutical industries develop and hone new technologies, the process for regulating them needs to keep pace, Food & Drug Administration commissioner Margaret Hamburg said earlier today at the National Health Policy Conference here.

“Just as biomedical and life sciences research has evolved in the past decade, regulatory science … must also evolve,” Hamburg said.

Speaking before a crowd of about 200 people who braved the approximately two-and-a-half feet of snow that blanketed the Washington, D.C., region over the weekend, Hamburg said the FDA needs to streamline regulatory procedures, which have not kept pace with innovations throughout the life sciences industry.

The 510(k) clearance process for medical devices is among the regulatory procedures the federal watchdog agency plans to reassess under Hamburg’s leadership — a necessary step in overseeing an industry that is constantly transforming itself.

“The 510(k) process was developed in a different era,” Hamburg told MassDevice. “Devices have grown very much in terms of the complexity and in advancement, where we have an obligation to make sure we have a regulatory oversight program that really addresses the needs of the evolving technology and assure we are adequately assessing between safety and effectiveness, and what possible steps could or should be taken.”

Striking a balance between effective regulation and promoting innovation is as important to the manufacturers as it is to consumers, she added. The 510(k) process needs to evolve along with the biomedical science that drives the medical device industry — for both the safety of the consumer and the success of the industry.

“I’m very, very supportive of innovation. I see that as fundamental to progress,” Hamburg said. “And an effective regulation system can help us do a better job of assuring the medical products we have are safe.

“Consumers need it and manufacturers need it in assuring consumer confidence in their products,” she added. “So ultimately we all share common goals.”

During her address, Hamburg outlined the FDA’s three major focuses under her leadership: Preventing problems, balancing risk and maximizing outcomes. She cited lessons learned from the peanut salmonella outbreak in late 2008, when eight people died and thousands were sickened. In April 2009, amid concerns that pistachios were tainted with salmonella, the FDA immediately issued warnings and investigated the issue.

“The situations were admittedly different,” Hamburg said. “But between peanuts and pistachios, the FDA had begun a shift toward prevention.”

Also speaking at the conference was Health and Human Services secretary Kathleen Sebelius, who underscored the Obama administration’s commitment to passing healthcare reform this year.
“The case for reform is still fundamentally before us,” Sebelius said. “The message is pretty straightforward: We need to step up and finally deal with comprehensive health reform in America.”