U.S. Premarket Notification [510(k)] Submission

As mandated by the Federal Food, Drug, and Cosmetic Act (the Act), a 510(k) submission should be submitted to the FDA 90 days prior to marketing a Class II medical device in the U.S., unless the device is Class III and requires a Premarket Approval (PMA) or is Class I or Class II 510(k) exempt. In addition, all establishments marketing medical devices in the U.S. are required to register their establishment and list their medical devices with the FDA annually in accordance with 21 CFR Part 807. Establishments located outside the U.S. are required to name a U.S. Agent during intial and annual establishment registration.
Our Services：
Application strategy consulting, including proposed device classification Determine comparator devices Develop the test plans and provide testing services Prepare 510(k) submission Communicate with FDA scientific review staff on your behalf Complete establishment registration and medical device listing U.S. Agent service