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FDA In Brief: FDA to launch new program to help advance innovation by promoting greater efficiency and consistency in review of certain moderate-risk medical devices

September 5, 2018

Media Inquiries

  Alison Hunt
  240-402-0764

“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, M.D. “To promote these goals, we’re launching a pilot program that’ll help us evaluate whether we can modernize the premarket submission process for medical devices, by allowing applicants to submit information to us using a new, more streamlined electronic format. While this new, highly-interactive submission process will not change our statutory or data requirements, we expect it’ll reduce application review times as much as 30 percent—from a maximum of 90 days, down to 60 days—by allowing us to receive and evaluate information much more efficiently. The structured format will also improve the consistency of our review. Taken as a whole, this new process will improve our overall productivity, enabling the agency’s review staff to put more of our time and resources into evaluating applications for devices that pose the highest potential risks to patients. Simplifying the process to submit applications is part of the FDA’s ongoing effort to ensure that we’re giving patients more efficient access to safe, effective, and high-quality medical devices.”

Tomorrow, the FDA will launch the Quality in 510(k) (“Quik”) Review Program Pilot for certain moderate-risk medical devices as part of the agency’s ongoing efforts to improve the efficiency and consistency of the premarket notification (510(k)) review process. The Quik Review program pilot will allow sponsors of certain moderate risk devices to use the agency’s free eSubmitter software to structure their 510(k) applications for submission to the FDA. Through a downloadable electronic form, submitters will be able to fill out pre-existing fields required in all 510(k)s. This new, electronic process will enable the FDA’s staff to receive this information in a streamlined format that allows for a more consistent and efficient approach to review.

The FDA expects that the new format will help reduce the maximum time to make a review decision for most products in the Quik Review program pilot from 90 days to 60 days. The new format does not change any statutory or data requirements for device sponsors to demonstrate their devices are substantially equivalent to a predicate device.

The agency has identified a list of approximately 40 product codes that are eligible for this pilot. These are all moderate-risk medical devices that are considered to be well-understood by the FDA. This includes, for example, electronic stethoscopes, surgical wire and certain cameras used by ophthalmologists. At the anticipated end of the pilot period in 2019, the FDA will examine the continued feasibility of the program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Page Last Updated: 09/05/2018
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