The primary institution responsible for approving and regulating medical devices in the US is the Food and Drug Administration (the FDA). The FDA has created a classification system based on risks and subdivides medical devices into three categories: Class I, Class II, and Class III. The classifications rank the devices with the associated risks. For instance, Class I being the lowest risk, while Class III being the highest.
There are many different regulations that medical device manufacturers need to look into to bring their devices to the market. Here are the most significant regulations on medical devices in the US.
Medical Device Reporting
Manufacturers and distributors must register with the FDA to have their devices marketable. The registration process must be verified between Oct. 1st and Dec. 31st each year. Manufacturers must provide every detail of their device, and if required by the FDA, must submit a 510(k).
Premarket Notification 510(k)
The premarket notification is typically required for the most medical device. A device requiring the premarket notification cannot be distributed within the US until it has been authorized by the FDA.
Premarket approval (PMA) is a process designed to evaluate the risk a device could post on a patient. Case III devices must submit premarket approval applications. The manufacturer will also be ineligible to market the device until the device has been approved. The average time for premarket approval, per the FDA, is approximately 180 days. However, it can often take a bit longer.
Investigational Device Exemption
The Investigational Device Exemption, also known as IDE, allows the medical device manufacturers to gain evidence to prove the device’s effectiveness and safety. Data gathered during IDE studies is typically used for supporting a PMA. All studies must be approved by both the FDA and the Institutional Review Board (IRB). Clinical studies on lower classified devices only need IRB approvals.
Quality System Regulation is enforced by the FDA. This system included requirements for controls, methods, and facilities that were used in designing and manufacturing the products, as well as where the packaging, labeling, installing, and purchasing is based. There are no exact guidelines on how to make a device specifically compliant under the QS REgulation, however, it is more of a framework for manufacturers to abide by.
Medical Device Reporting
Medical Device reporting is established to help manufacturers and the FDA identify and negative effects a device may have. Any death or injury must be reported through the MDR program. Device malfunctions will need to be reported to the FDA.