FDA Launches ‘Quik’ 510(k) Review Pilot Program

The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third.  The pilot, dubbed as “a Turbo Tax for information submitted in 510(k)s,” by FDA Commissioner Scott Gottlieb, will allow device manufacturers to submit premarket notifications electronically using “eSubmitter” software, as long as the device is classified under one of the specific product codes included in the pilot program and is not a combination product.  In addition to lower risk devices, the pilot program includes some higher risk Class II devices, such as surgical lasers, certain endoscopic equipment, and certain imaging devices (e.g., MRI and stationary X-rays).

The FDA’s stated goal is to review 510(k) applications for devices that meet the eligibility requirements within 60 days, rather than the typical 90 days for traditional applications.

FDA Commissioner Scott Gottlieb also commented:

“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.”