MEDICAL DEVICE REGULATION
The U.S. Food and Drug Administration (FDA) regulates medical devices to ensure that they are safe and effective for their intended use.
The FDA's medical device regulations are based on the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA classifies medical devices into three classes based on their risk:
- Class I: Low risk devices, such as tongue depressors and bandages.
- Class II: Moderate risk devices, such as surgical gloves and contact lenses.
- Class III: High risk devices, such as pacemakers and implantable defibrillators.
The FDA's regulatory requirements for medical devices vary depending on the class of the device.
The FDA enforces its medical device regulations through a variety of activities, including inspections, recalls, and warning letters.