FDA to Review 510(k) Clearance Process for Medical Devices

WASHINGTON — For manufacturers who rely on FDA approvals for their livelihood, clarity is a priceless commodity. New FDA Chief Jeffrey Shuren believes the device approval process is ripe for review, and he hopes to illuminate the premarket notification, or 510(k) process, during a public meeting Feb. 18.

In a press release, Shuren pointed out that it has been more than three decades since the agency established the current rules that govern the clearance process for medical devices. "We are looking forward to hearing from the public on issues related to this program to help us improve it," Shuren said.

According to the release, the FDA receives more than 3,000 510(k) submissions each year. Under the process, device manufacturers must show that their new device is "substantially equivalent" to a device already legally on the market that does not require a premarket approval.

Ron Richard, CEO of San Diego-based SeQual Technologies, said the FDA is planning to add hundreds of new reviewers this year to unclog some of the bottlenecks at the agency. If the meeting can add some clarity to such issues as how "predicate" devices (previously cleared devices that may support a manufacturer's claim) are viewed, Richard believes the time will be well spent.

"Manufacturers want to know what the rules are and how we are supposed to engage and work with the FDA," said Richard. "Any manufacturer in the medical field is going to be looking for the FDA to disclose to us what they need and what they want. If there are going to be changes to the premarket approval process, clearly define what those changes are going to be, and take as many grey areas out as possible."

The FDA classifies medical devices in three categories according to their level of risk. Class III devices, including heart valves and intraocular lenses, have the highest level of risk and generally require premarket approval to support their safety and effectiveness before they can be marketed.

Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can only be marketed after the FDA has found them to be substantially equivalent to legally marketed devices that don't require premarket approval. Devices that are not found to be substantially equivalent to a legally marketed device require premarket approval.