FDA CDRH Special 510(k) Pilot Program

Quality in 510(k) “Quik” Review Program Pilot

The Quality in 510(k) (“Quik”) Review Program provides an alternate method to submit a premarket notification (510(k)) to the FDA using the eSubmitter software to format the submission. The FDA has identified a list of product codes that are eligible for this pilot. These device types are moderate risk and are considered to be well-understood by the FDA. This means the FDA believes these products can be reviewed in an efficient manner while still maintaining safety and effectiveness. The goal is for the FDA to make a final decision within 60 days of receipt of a 510(k) for an eligible device.

The purpose of the Quik Review Program pilot is to evaluate the Quik Review Program and whether use of the FDA’s free eSubmitter software will produce well-organized submissions that can be reviewed more efficiently to help promote timely access to safe, effective, and high-quality medical devices.

What are the eligibility criteria for the Quik Review Program Pilot?

A device must meet all of the following criteria to be eligible for participation in the Quik Review Program pilot:

1. The device’s primary product code is listed on FDA website notice (FDA Link).
2. The device is not a combination product (such as a drug-device or biologic-device combination).
3. The lead Center for the device is the FDA’s Center for Devices and Radiological Health (CDRH).
4. The submission was constructed with the eSubmitter template “CDRH: Non-In Vitro Diagnostic Device – 510(k).”

If any of the above criteria are not met, the submitter will have to submit the 510(k) using the traditional method of submitting a valid eCopy to the Document Control Center. If the submitter attempts to submit a 510(k) using the eSubmitter application for a product that does not meet the eligibility criteria, it will be rejected for an invalid eCopy.

Refer to the FDA website at this FDA Link, or search the FDA website for “Quality in 510(k) “Quik” Review Program Pilot” is the link is no longer valid.

If you would like to discuss this new pilot and how it might be used for one of your products, leave us a comment and we will contact you.

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