Last week the US Government Accountability Office (GAO) released its long-awaited report on the FDA’s medical device approvals process. As expected, the report suggested that FDA review was too lax for certain class III devices cleared under 510(k) submission. Specified devices included metal-on-metal hip implants. The GAO recommends that class III devices currently eligible for market clearance by 510(k) either be downclassified, if appropriate, or subject to the PMA process.
Between 2003 and 2007, 228 class III devices were cleared by 510(k). Also during that time period 217 original PMAs were reviewed, so broadening PMA regulations to cover all class III devices would likely dramatically increase the time to approval and strain FDA resources. At present, 510(k)s are cleared in about 90 days; PMAs average just under a year. For manufacturers, costs and time-to-market would also be increased by the completion of a pivotal study in support of the submission.
The FDA has said it agrees “in general” with the GAO’s findings, and while they have not yet announced any specific plans or timelines for establishing a more rigorous regulatory process, the agency will likely take heat until they do. Congressional hearings over device safety are said to be in the works, and a group of FDA scientists who reported separate complaints to lawmakers continue to voice their concerns.