The U.S. Food and Drug Administration is in charge of protecting public health by assuring the safety, efficacy and security of medical devices, among many other things. With their thorough monitoring, the FDA ensures that medical devices do their intended job. When a device or drug is approved, patients understand that they will be receiving quality health care that has been proven effective through numerous tests. The FDA either denies the device, approves the device after reviewing a premarket approval (PMA) application that has been submitted, or it “clears” a device after reviewing a premarket notification, otherwise known as a 510(k).
According to the FDA, “In order to acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is ‘substantially equivalent’ to a device that is already legally marketed for the same use.” After thorough performance testing, the FDA will determine whether the machine is suitable for widespread use.
If you are in the market for a new EKG machine for your office, check out the large selection of FDA-approved EKG machines, EKG cables and sensors and a wide variety of other medical devices at Medical Device Depot to help enhance your practice and your patient experience.