Learn more about the processes related to Medical Devices and stay up to date with all the important news that the FDA has for manufacturers.
Premarket notification, also called 510(K), is a notification required by the FDA for medical device manufacturers who want to bring their medical devices into the United States.
Learn more about the 510(K) and its processing times.
The FDA has its own regulation (21 CFR Part 820) to regulate the quality systems of medical device manufacturers.
If your medical device includes the use of software, learn what you have to take into account when submitting your device to the FDA.