Classify Your Medical Device for USA market

The Food and Drug Administration (FDA) regulates medical devices in USA. FDA has established classifications for about 1700 generic types of devices and grouped them into sixteen medical specialties referred to as panels. Each of these generic types of devices is assigned to one of 3 regulatory classes based on the level of control necessary to assure the safety and effectiveness of the medical device. The three classes and the requirements which apply to them are listed below:

1. Class I General Controls
2. Class II General Controls and Special Controls
3. Class III General Controls and Premarket Approval

Read much more details on FDA official page: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device