FDA Launches ‘Quik’ 510(k) Review Pilot Program
| Printer friendly version
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.”
Nathan Lee is an associate at our Orange County Office. Nathan Lee helps clients with U.S. and foreign patent prosecution and patent portfolio management.
Prior to joining the firm, Nathan attended New York University School of Law where he served as a Staff Editor of the Journal of Intellectual Property and Entertainment Law. In 2010, he received his Bachelor's Degree in Chemistry with a minor in Biology at Cornell University. Nathan also has research experience in Nanomaterials, Biomaterials, and Protein Chemistry.
Nathan worked as a summer associate at the firm in 2015 and joined the firm in 2016.
Click here to read full bio View all posts published by Nathan Lee »
By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.