Regulatory/Compliance

For Diana Zuckerman, last week’s open forum on the 510(k) process at the Center for Devices and Radiological Health felt a little like going one-on-400.

The president of the National Research Center for Women & Families told MassDevice she felt quite conspicuous as the lone public health voice in a room full of medical device industry advocates.

“I was pretty much it,” Zuckerman told us. “I think it was all industry, one patient and me and on the discussion panel it was industry plus FDA people and me.”

The Food & Drug Administration convened a day-long public hearing on its 510(k) clearance program for medical devices in Washington, D.C., Feb. 18, drawing comments from a variety of stakeholders.

The program, by which the vast majority of medical devices are approved by the watchdog agency, is often called a "fast-track" program because it relies on previous approvals of similar or "predicate" devices. Supporters of the process say that’s a misnomer; detractors say the system isn’t as rigorous or robust as it should be.

WASHINGTON — As the medical device and pharmaceutical industries develop and hone new technologies, the process for regulating those technologies and products 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 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.

Companies looking to get medical devices to market might want to brush up on their probability theory, after the Food & Drug Administration issued new guidelines for statistical method it says can speed clinical trials.

The FDA said medical device makers can use Bayesian statistical methods to design and analyze clinical trials. Bayesian probability applies an algorithm allowing companies to combine data from previous trials with current trial data. That, in turn, could provide "sufficient justification for smaller or shorter clinical studies," according to a press release.

The Food & Drug Administration is asking Congress to foot its $4.03 billion bill to overhaul its own operations and increase its scrutiny of the medical device, pharmaceutical, food and tobacco industries.

As it lays out its ambitious plans for fiscal 2011 and beyond, the federal watchdog agency wants a 23 percent boost to its annual budget. The FDA’s FY2010 budget came in at $3.28 billion, itself a 17.5 percent increase over the prior year’s $2.79 billion allotment.