Have you ever wondered who approves and regulates medical devices, such as pacemakers and kidney dialysis machines?

Who Regulates Medical Devices

The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label and/or import medical devices sold in the United States. CDRH also regulates radiation-emitting electronic products both medical and non-medical, such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

How Are Medical Devices Classified

Medical devices are classified into Class I, II, and III, with regulatory control increasing from Class I to Class III. The device classification regulation defines the regulatory requirements. Most Class I devices and some Class II devices are exempt from FDA Premarket Notification submission. Class III devices, which pose a significant risk of illness or injury, need FDA Premarket Approval.

How Are Medical Devices Registered

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA, and all registration information must be verified annually. Foreign manufacturers must also designate a U.S. Agent. Most establishments are also required to pay a fee, which is not related in any way to FDA’s final decision on submission.

Class II medical devices cannot be distributed without an FDA letter of authorization that demonstrates that the device is substantially equivalent to one legally in commercial distribution in the United States.

How Does the FDA Regulate Medical Device Manufacturers

FDA inspects and regulates manufacturing processes related to the methods used in the facilities and controls for the following:

  • Designing
  • Purchasing
  • Manufacturing
  • Packaging
  • Labeling
  • Storing
  • Installing
  • Servicing

Manufacturers are also required to report to the FDA all incidents and malfunctions of devices, with the goal of detecting and correcting problems in a timely manner.