When some consumers think about the Food and Drug Administration (FDA), approval of drugs most often comes to mind, but approval and regulation of medical devices is an equally important responsibility of this federal agency. As in its regulation of drugs, the FDA’s approval process for medical devices is designed to ensure the safety of the patient and with the efficacy of a product’s use in mind.
The FDA completes its review and approval of a medical device through its Center for Devices and Radiological Health (CDRH) and, depending upon the risk, use and complexity of the device, assigns it to a category (called Classes) according to risk. For example, Class I (low risk) devices include facemasks and Class II devices include items such as contact lenses or heart rate monitors. Implanted devices, such as replacement hips or pacemakers, are Class III.
While all classes of medical devices undergo review, the FDA’s regulatory process for Class III devices is the most stringent. This process, which includes review of the initial concept, lab testing results, prototype refinement and clinical trials is reviewed before approved. Once approved, the FDA conducts post market safety monitoring of the device to ensure continued safety and efficacy.
Both treating physicians and consumers can use a medical device with the knowledge that it has been through a thorough safety and efficacy review. To learn more about medical device regulation: https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm and https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ucm2005300.htm