Esterel Technologies

What is FDA 501(k)?

FDA Section 510(k), or Premarket Notification (or PMN), of the Food, Drug and Cosmetic Act requires device manufacturers to register and/or notify the FDA at least 90 days in advance of their intent to market a medical device. Specifically, medical device manufacturers are required to submit 501(k) premarket notifications if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. The safety implications are similar to FAA requirements, where life-critical devices and/or safety-critical devices are required to have a prudent design, code, and test/QA strategy in order to produce a product that is safe to use.