Saturday, February 06, 1999
"We are using FDAMA to make faster decisions by concentrating our efforts on higher-risk devices," said James Dillard, MS, deputy director of the FDA's Division of General and Restorative Devices. "We have exempted low-risk devices and made processes less cumbersome."
Dillard spoke at a Thursday afternoon symposium entitled "Regulatory Aspects in Orthopaedics," and in a brief interview. He said that another factor in streamlining the approval process is a reengineering initiative that began about two years ago. "The 510K program for pre-market notification was re-engineered with two new types of submissions," he said. The first is a special type done in 30 days. The second is abbreviated, using the consensus standards of standards organizations. Third, the traditional 510K is used.
"Other than 510K, we have re-engineered product development protocol and pre-market approval processes. This is resulting in faster approval of products. Statutory dates are closer to being met literally."
A. Seth Greenwald, D. Phil. (Oxon), PhD, Director of Orthopaedic Research Laboratories at Mount Sinai Medical Center in Cleveland described what he called the "dark side" of FDA approval processes. "Approval can take three to five years," he said. "Clinical trials are difficult to conduct. Companies are moving overseas.
"But we hope the FDA will bring products to market in a more timely fashion. It must now respond to manufacturers within 180 days."