FDA Proposes Criteria for Determining Completeness of 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has released a draft guidance entitled “Refuse to Accept Policy for 510(k)s.” In the document, the FDA proposes it will only accept a premarket notification [510(k)] submission for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 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.

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 in late June, the FDA promised to speed up review processes in exchange for the hiked user fees companies must now pay. This proposal is an attempt to keep that promise, as focusing on complete applications only will reduce time wasted with companies that submit proposals with 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Any comments or suggestions regarding the draft guidance must be submitted to the FDA before Sept. 27 to be considered for the final draft.