Alerts and Updates

FDA Unveils New Quality in 510(k) "Quik" Review Program Pilot

October 22, 2018

According to the FDA, one of its purposes is to evaluate whether use of the FDA’s free eSubmitter software will produce well-organized submissions that can be reviewed more efficiently.

The 510(k) process provides a review procedure for marketing clearance of devices that are “substantially equivalent” to other approved devices or to a standard recognized by the Food and Drug Administration (FDA). 

On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the alternative the Quality in 510(k) “Quik” Review Program Pilot. Under the program, the FDA’s goal is “to make a final decision within 60 days.” The review is expected to be interactive—without putting the submission on hold for a request for Additional Information (AI)—with the expectation that 510(k) applicants will respond quickly to any AI requests. It remains to be seen whether the AI will typically require extensive testing, resulting in delays.

Only certain devices that fall within a list of product codes are eligible for the Quik Review Program Pilot. The FDA notes that the eligible devices are well-understood and of moderate risk. Combination products are not eligible even if they fall under an eligible primary product code. The FDA requires that the lead center for review of the device be the Center for Devices and Radiological Health (CDRH). 

According to the FDA, one of its purposes is to evaluate whether use of the FDA’s free eSubmitter software will produce well-organized submissions that can be reviewed more efficiently. Accordingly, the FDA requires that the submissions be made using the FDA’s eSubmitter software and a template titled “CDRH: Non-In Vitro Diagnostic Device – 510(k).” The eSubmitter template asks for the same information as is required for a Traditional 510(k) submission. The applicant should format the submission as a ZIP file. Although the eSubmitter software has been around since 2004 and its 23rd version was launched on July 21, 2018, there may be technical challenges both in terms of utility and ease of use.

The FDA requires a cover letter having the following statement to distinguish the submission from a Traditional 510(k) submission:

This submission is part of the Quik Review Program Pilot, and is organized according to the standard eSubmitter output package. Accordingly, special eCopy processing applies. As per the agreement for the Quik Review Program Pilot, no full paper copies are required.

If the FDA determines that a 510(k) is ineligible for the Quik Review Program Pilot, the FDA will send an email to inform the applicant of this decision and the reason for the decision. Ineligible products need to be processed via a Traditional 510(k) submission and the submission will be reviewed using the traditional 90-day time frame.

For Further Information

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