FDA MEDICAL DEVICE REGULATIONS PREPARE FOR CHANGE

 

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.

Prepare for the FDA QMSR Changes Effective February 2, 2026

With the FDA Quality Management System Regulation (QMSR) changes on the horizon, it's critical to be prepared. QARS Solutions is here to help. Our team of medical device quality engineers and software quality experts can position your organization for success when the new regulations go live on February 2, 2026.