Devices & Diagnostics

Proposed 510(k) guidance from FDA requires agency response to applicant in 15 days

A proposed guidance to expedite the acceptance process for the 510(k) program at the U.S. Food and Drug Administration would require the agency to respond in 15 days to an applicant. In that period, FDA reviewers would look at whether the application is complete from an administrative point of view. The goal is to ensure […]

A proposed guidance to expedite the acceptance process for the 510(k) program at the U.S. Food and Drug Administration would require the agency to respond in 15 days to an applicant.

In that period, FDA reviewers would look at whether the application is complete from an administrative point of view. The goal is to ensure that the application has provided FDA all the information to conduct a substantive review that would conclude with a clearance or rejection. Acceptance for detailed review is based on the completeness of the application, per a checklist, and not the quality of the data presented, according to the FDA document.

This marks a significant difference from previous guidance issued in 1993 titled “Center for Devices and Radiological Health’s Premarket Notification (510(k)) Refuse to Accept Policy” and in 1994  called “510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1.”

Those documents provided broad principles instead of specific criteria resulting often in FDA’s acceptance of applications that were incomplete. The current proposal hopes to change that by providing a detailed checklist.

“Focusing FDA’s review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible,” the document stated.

The proposal also suggests that if reviewers fail to respond to the applicant in 15 days, the application is automatically accepted for substantive review.

The delay in getting devices approved has been one of the primary criticisms that has been directed at the FDA by the medical device industry and has invited Congressional scrutiny. The oft-heard complaint is that U.S. patients are the last to receive novel therapies because of FDA’s foot-dragging. The FDA agreed to some performance goals in the latest round of industry negotiations related to its user fees that was later ratified by Congress.

To counter the impression that it delays the approval of new therapies, the FDA is trying to adopt new measures — one including an early review program of complex medical devices.

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