FDA Releases Proposal to Improve Evaluation of 510(k) Sumbissions

The U.S. Food and Drug Administration (FDA) has released a draft guidance entitled “Refuse to Accept Policy for 510(k)s.” In the document, the FDA proposes it will only accept a premarket notification (510(k)) submission for substantive review if it is deemed to be “complete.” The document also outlines the procedures is and criteria it will use to determine completeness of an application for 510(k) clearance. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.

For a device to be eligible for 510(k) clearance as opposed to an FDA approval, the device must be found to be substantially equivalent to an existing device. It must have the same intended use as the predicate device, and must have either the same technological characteristics as the predicate device, or have different technological characteristics accompanied by a submission containing information, including appropriate clinical or scientific data if necessary, that demonstrates the device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness.

The previous guidances relating to 510(k) RTA policy and the checklist currently used for acceptance review have focused on defining broad issues or principles. Additionally, the previous checklist deals largely with administrative elements but it does not address specific content that is essential for 510(k) review. As a result, FDA accepts many inadequate submissions for review and FDA staff invests significant time in constructing extensive letters requesting all of the additional information needed to conduct a substantive review. This approach is an inefficient use of resources and frequently lengthens review times.

According to the proposal, focusing the agency’s resources on complete applications “will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible.”

When the latest version of the Medical Device User Fee & Modernization Act was approved and passed by D.C. lawmakers, the FDA promised to speed up review processes in exchange for the hiked user fees companies would be paying. This proposal is one step in the direction of keeping that promise, as focusing on complete applications only will reduce time wasted on back-and-forth with companies regarding inadequate information.

“FDA agreed to performance goals based on the timeliness of reviews,” The proposal reads. “Acceptance review therefore takes on additional importance in both encouraging quality submissions from sponsors of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions.”

Any comments or suggestions regarding the document must be submitted to the FDA before September 27 to be considered for the final draft.