FDA looks to strengthen premarket review of devices
The Food and Drug Administration is seeking public comment on the agency’s efforts to modernize the 510(k) program, which accounts for the majority of medical devices that the FDA reviews.
A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (predicate device) that is not subject to premarket approval.
“We’re considering whether, in addition to the information in the 510(k) database, the FDA should post on its website a list of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices,” wrote FDA Commissioner Scott Gottlieb, MD, and Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a blog.
“Doing so would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements,” added Gottlieb and Shuren. “However, we recognize that for some types of well-established technologies there is not a need for improvements, and reliance on older predicates would not only be appropriate but necessary.”
In addition to seeking comment on its overall approach to modernizing the 510(k) program, the FDA has posed several questions that the agency wants the public to answer to help inform its regulatory policy development:
- Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
- Should the FDA consider using other criteria to inform our point of reference?
- Are there other or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices?
- Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?
Submitters must compare their 510(k) device with a similar legally marketed U.S. device. A device recently cleared under 510(k) is usually used as a predicate device. However, any legally U.S. marketed device may be used as a predicate.
“One of our goals is to ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development,” according to Gottlieb and Shuren. “We believe this means that, where appropriate, new medical devices coming to market under the 510(k) pathway should either account for advances in technology that can improve the safety or performance of these products, or demonstrate that they meet more modern safety and performance criteria.”
Federal law requires manufacturers to submit a new 510(k) when changes or modifications made to an existing medical device could significantly affect its safety or effectiveness or the manufacturer makes a major change or modification in the intended use of the device.