By Adrienne R. Lenz — On September 6, 2018, FDA launched the Quality in 510(k) Review Program Pilot (“Quik”). With the name “Quik,” it has a lot to live up to. The goal of the program is to simplify the 510(k) process by providing an alternate method of preparing a 510(k) using FDA’s eSubmitter software to format the submission. The new process is being piloted for a select list of device types. Eligible devices must also be reviewed by CDRH, not be classified as combination products and constructed with the eSubmitter template “non-In Vitro Diagnostic Device – 510(k).” The agency considers the eligible devices selected to be moderate risk and well-understood. According to the user manual, the eSubmitter tool is “is intended to automate the current paper submission process, allowing for quicker completion once users are accustomed to the software, as well as speed up the filing process with FDA.” It can be…
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