#bestpractices #medicaldevice #compliance
Companies looking to market and sell medical devices in the United States must obtain approval from the U.S. Food and Drug Administration (FDA).
The first critical step to obtaining approval is classifying your medical device, as it determines the type of premarket submissions and applications that will be required for FDA review.
So where do you start, and how do you know that your device is assigned the proper classification?
In this article, you’ll learn:
- FDA criteria for classifying Class I, II, and III devices
- Differences between the medical device classes
- Steps for assigning your medical device the right classification