Regulatory/Compliance

The Food & Drug Administration’s proposals to re-vamp its most-used medical device clearance protocol are a mixed bag, according to the agency’s former staff director for the program.

Heather Rosecrans, now a regulatory adviser at the healthcare consulting firm Greenleaf Health LLC, told the audience at the Cooley LLP Medical Device Conference in Boston that she’s skeptical of one new feature in particular: the Centers for Devices and Radiological Health’s proposal to create a new Class IIb designation, which would require clinical data.

The Food & Drug Administration extended the comment period on its medical device user fee program until Nov. 1.

On Oct. 1, the FDA boosted the user fees medical device makers pay for applications for clearance or approval from the federal watchdogs. The new fee schedule instituted an across-the-board hike of 8.5 percent. Companies must pay an initial fee of $2,179 to register with the FDA.

Dr. Joshua Sharfstein, deputy commissioner of the Food & Drug Administration, told packed house at Harvard Medical School last night that the agency has a ways to go in providing accountability for its decisions.

"A lot of the accountability right now, frankly, comes from me or [FDA head Dr. Margaret] Hamburg," Sharfstein said. "If someone says something that doesn’t make sense, we’ll push them on it and there will be a whole of hand-wringing, but I wouldn’t tell you that we’re where we want to be."