Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These regulations are generally quite complex, but such complexity is necessary to ensure safety and effectiveness of devices intended for human use. This article provides a general overview of the current medical device regulations in the United States.
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and Class III. Class I devices are associated with the lowest risk, while Class III devices are associated with the highest risk.
There are several regulations that manufacturers looking to introduce a medical device to the US market have to comply with. Here are the 7 most significant regulations governing medical devices on the US market:
1) Establishment Registration & Medical Device Listing – 21 CFR Part 807
Both manufacturers and distributors have to register with FDA to be able to introduce their devices to the market. There is a fee associated with the registration process and registered information needs to be verified between October 1st and December 31st of each year.
Manufacturers have to provide all details regarding their device and, in case it is required by the FDA, submit a 510(k) and premarket approval application (PMA). Non-US based organizations must hire a US agent and provide his/her primary contact information to the FDA. The designated agent may be, but does not have to be, an official correspondent to the FDA.
2) Premarket Notification 510(k) – 21 CFR Part 807 Subpart E
Premarket notification is required for most, but not all, medical devices. If a device requires the submission of premarket notification, it cannot be commercially distributed in the United States until it receives an authorization from FDA.
3) Premarket Approval (PMA) – 21 CFR Part 814
Premarket Approval (PMA) is a risk-based evaluation process designed for devices that pose a high threat to patients’ health. Manufacturers of Class III devices (and devices that are not substantially equivalent to Class I or Class II) are required to submit a premarket approval application. The manufacturer cannot start any marketing activities before receiving premarket approval. Statutorily, it should not take the FDA more than 180 days to issue a decision on whether a submitted PMA has been approved or rejected, but in reality the waiting time is often a bit longer.
4) Investigational Device Exemption (IDE) – 21 CFR Part 812
Investigational Device Exemption (IDE) allows manufacturers to use the device in question in clinical studies to collect evidence that proves its general safety and effectiveness. Data gathered during IDE-related studies is usually used to support a PMA. All studies performed on devices associated with a significant risk must be approved by the FDA and the Institutional Review Board (IRB) before manufacturers may begin their studies and start collecting relevant data. Clinical studies on devices of lesser risk must be approved only by the IRB.
5) Quality System Regulation (QS Regulation) – 21 CFR Part 820
The Quality System Regulation includes requirements related to methods, controls, and facilities used for the designing, manufacturing, labeling, packaging, storing, purchasing, installing, and servicing of medical devices. The quality system enforced by the FDA is also referred to as Current Good Manufacturing Practice (CGMP).
Due to wide variety of medical devices, the CGMP does not provide exact guidelines on how to make a specific device compliant under the Quality System Regulation. Instead, it is meant to serve as a framework for all devices.
6) Labeling – 21 CFR Part 801
Labeling regulations lay out the requirements for the labels on the device and the descriptive literature related to the device.
7) Medical Device Reporting – 21 CFR Part 803
Medical Device Reporting (MDR) has been established in order to help FDA and manufacturers identify and monitor the negative effects of a specific device in a timely manner. All deaths or serious injuries must be reported to the FDA under the MDR program. This responsibility applies to both manufacturers and importers. In the case of device malfunctions, importers are required to report the malfunction only to manufacturers, which then need to report the issue to FDA.
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