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02. 10.2018

FDA launches pilot to shorten some 510(k) approval times

The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets.

The Quality in 510(k) “Quik” Review Program uses the agency’s eSubmitter software to format each submission and accepts 39 product codes for device types that it considers to be well-understood by the FDA. The agency’s goal is to make a final decision within 60 days of receipt of a 510(k) application for an eligible device.

The FDA said the pilot will help it evaluate the Quik Review program and determine whether the 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.

The eSubmitter template asks for the same information typically requested in a traditional 510(k). After it is constructed, the eSubmitter application will format the submission into a ZIP file that filers should copy to a CD, DVD, or USB drive. Eligible devices must be regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Combination products such as drug-device or biologic-device combinations are not included. Instructions for downloading and installing the eSubmitter application are available at the eSubmitter Download and Installation website.

If the submission is eligible for the Quik Review program pilot, the agency will not conduct a refuse-to-accept review or plan to put the submission on hold to request additional information. Instead, submitters are expected to respond quickly to FDA requests for additional information.

If the 510(k) is found to be ineligible for the Quik Review pilot, the FDA will email the official contact of the 510(k) to inform them of this decision and the reason why a review cannot be completed within 60 days. Then the 510(k) will be reviewed according to standard procedures using the traditional 90-day timeframe.

Source: Medical Design & Outsourcing