FDA to Overhaul Medical Device Approval
Since 1976, device manufacturers have been able to file for approval under an expedited procedure if they could prove their new products were substantially equivalent to those grandfathered in when Congress established the pathwayknown as 510(k).
Under a Medical Device Safety Action Plan issued in April, the FDA now aims to retire older base products, called predicate products, some of which are no longer on the market, so that they can no longer be used for comparison.
One of the first steps will be to release information about approved devices that have demonstrated substantial equivalence to older predicate devices, focusing on those that use predicates more than 10 years old. At the same time the agency will seek public feedback about devices on the market.
We don’t think these devices are unsafe — they met our standards for reasonable assurance of safety and effectiveness — but we are concerned that this practice of relying on predicates that are old, and may not reflect modern performance characteristics, Commissioner Scott Gottlieb and Center for Devices and Radiological Health Director Jeff Shuren said in a statement earlier this week.
The FDA is moving swiftly forward after alarming results of investigations into medical device failures became public. According to reports, the FDA’s accelerated review process may have missed problems and put consumers at risk. Gottlieb stressed, however, that the FDA had already planned changes.
What the government wants to do, the administrator said, is to constantly push the market toward incorporating better technology and better capabilities by advancing the predicates used as the basis of approvals and assure that manufacturers incorporate newer and better technology.
The FDA wants to finalize its guidance on establishing an alternative accelerated pathway early next year.
In 2017, the agency cleared 3,173 devices through its existing system. Nearly 20% were based on a predicate device more than 10 years old.