During the recent annual meeting of the Florida Medical Manufacturers Consortium in St. Petersb

During the recent annual meeting of the Florida Medical Manufacturers Consortium in St. Petersburg, Fla., Heather Rosecrans, former director of the 510(k) premarket notification staff at the FDA, and current vice president of regulatory affairs at the Medical Device Manufacturers Association, told the gathering that the 510(k) program has been misrepresented as overly flawed.

“It’s the most misunderstood program at the agency,” she said. “It isn’t a ‘fast-track’ program as many media outlets have said. It has always been a risk vs. benefit review, not a rubber stamp. But we need to keep up with the pace of technology and it’s good to have a new look at things.”