Medical devices are classified into Class I, II, and III, with increasing regulatory obligations from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.
The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
- Establishment Registration,
- Investigational Device Exemption (IDE) for Clinical Studies,
- Labeling Requirements,
- Medical Device Listing,
- Medical Device Reporting (MDR),
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA), and
- Quality System (QS) regulation.