專案與法規服務

The US Food and Drug Administration (FDA) provides a number of services to help manufacturers navigate the regulatory process for medical devices, including dental braces. Some of the key services include:

1. Premarket Clearance or Approval:
2. Quality System Regulations (QSR) Compliance:
3. Device listing:
4. Device labeling: 
5. Device Master Record (DMR) and Device History Record (DHR):
6. Device Tracking: 
7. Medical Device Reporting (MDR): 
8. Device Registration and Listing:

It's important to note that this is a general overview of FDA regulation services and some specific details may vary depending on the type of device and its intended use. I recommend consulting FDA's website for the most current and detailed information.