The Food and Drug Administration's 34-year-old 501-K premarket approval process for medical devices is inadequate for assessing today's rapidly changing technology and needs to be revamped to better serve the needs of patients, physicians and manufacturer, stakeholders testified during a public FDA meeting.
Several participants pointed to the FDA's use of “substantial equivalence” to approve new-product market entry as an area of concern that needs to be addressed. A product is deemed substantially equivalent if it has the same intended use and technological characteristics as a device already on the market, or if it has a different technology but the manufacturer proves that the different technology doesn't raise any new safety concerns.
“Our program of substantial equivalence that we've had for the past 30-something years may or may not be the program we need to face the challenges of tomorrow,” said Donna-Bea Tillman, director of the FDA's office of device evaluation, during her testimony.
In Mun, vice president of research and technology for North Florida Division of Hospital Corporation of America, said he was concerned that under the current substantial equivalence review process, manufacturers have been allowed to bring products to market that don't properly interface or network with existing products also used in a patient's treatment.
Such incidents can be unnecessarily costly to hospitals, Mun said. “We do feel abused in these cases, so we would like to ask FDA to please … stop this type of waste of time.”
An FDA work group is expected to submit a report on the 501K review process to Jeff Shuren, director of the FDA's Center for Device and Radiological Health, by the end of May and the Institute of Medicine is expected to release its independent report on the review process in March 2011.