The U.S. Food and Drug Administration (FDA) has launched a new pilot program intended to help ease the process of preparing a submission for 510(k) review of certain medical devices posing moderate risks.
According to a press release issued by the agency, the Quality in 510(k) (“Quik”) Review Program pilot will allow device manufacturers to use the FDA’s free downloadable eSubmitter software to enter the information required of all 510(k) applications into a standardized format. In addition to helping ensure the completeness of submitted 510(k) applications, use of the eSubmitter software will also free device manufacturers from submitting both a hard copy and an electronic copy of their application to the FDA.
The FDA also says that applications prepared using the eSubmitter software under the Quik Review Program pilot will not be subject to a “Refuse to Accept” decision by the agency, and that a final decision on the application will be made within 60 days of its original submission.
It is important to note that, according to the FDA, the Quik Review Program does not change any of the agencies’ requirements for the determination of substantial equivalence.
The FDA has established a dedicated webpage for the Quik Review Program. There, manufacturers can determine if the product codes applicable to their devices are included under the pilot.