The Basics of Medical Devices

Answer 1

A medical device is used for medical purposes on the body, aimed at diagnosis, treatment, or surgery. A medical device can be differentiated from a pharmaceutical product, which is also used for diagnosis or treatment, because a medical device does not have a biochemical impact and the effect is only physical. A medical device may have a pharmaceutical component. For example, an IV would be a medical device, but drugs that are put into a patient’s body through the IV is a pharmaceutical.

Medical devices are regulated by the Food and Drug Administration. Regulation by the FDA entails reviewing the evidence about the medical device to ensure that it is safe and seems to work as it is supposed to. Approval may be easier if a new medical device is essentially the same as or similar to a prior, approved medical device. The FDA also monitors medical devices to ensure that, after entering the market, there is no evidence of a safety concern that would warrant publishing additional information warning doctors and patients or concerns so severe that they require recall of the medical device. Warnings may be required where additional information could increase the beneficial effects, such as a clarification about appropriate use of a medical device. Recalls are warranted where the product is defective and/or a risk to health.

Examples of medical device span a large array of functions. For individuals with Diabetes, glucose monitoring and testing products are medical devices regulated by the FDA as these devices are critical to the treatment and management of diabetes. Breast implants are also considered medical devices as they are used in surgery. The FDA approves them and monitors their safety. Various products that use radiation, such as an x-ray, are common diagnostic tools and the FDA regulates them as medical devices to ensure their safety and efficacy.

Medical devices are a common part of health care and are similar in function to pharmaceutical products. It is the effect they have on the body that makes a product a medical device and not a drug. Medical devices are constantly being monitored and new medical devices are regularly coming out.