510(k) Reviews: FDA Launches 'Quik' Pilot

Regulatory NewsRegulatory News | 06 September 2018 |  By 

The US Food and Drug Administration (FDA) on Thursday launched a new pilot program aimed at reducing the time it takes to review moderate-risk medical devices by one-third.

The pilot, dubbed the Quality in 510(k) or "Quik" Review Program, will allow sponsors of moderate risk medical devices from some 40 eligible product codes to use FDA's free "eSubmitter" software to complete and submit their 510(k)s.

FDA says the products eligible for the program are "well-understood" and include devices such as electronic stethoscopes, surgical wire and cameras used by ophthalmologists.

"As technology evolves, patients have the opportunity to access more innovative medical devices that can help improve their health. To advance that progress, the FDA must also modernize its own review and submission process to make sure that our programs continue to be efficient, consistent and scientifically rigorous," said FDA Commissioner Scott Gottlieb.

Gottlieb said he believes the agency will be able to cut its review time for 510(k)s submitted through the pilot from 90 days to just 60 days without changing any statutory or data requirements. Additionally, Gottlieb said the efficiencies gained through the program will allow the agency to focus more resources on reviewing high-risk devices.

Using the eSubmitter software, sponsors will be able to fill out all required information for a 510(k) submission into pre-existing fields on a downloadable form that can be submitted electronically.

The pilot is currently expected to run into 2019, at which time the agency will determine whether to extend or expand the program.

Quality in 510(k) "Quik" Review Program Pilot


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