The U.S. Food and Drug Administration regulates MRI machines.
The Food and Drug Administration regulates every medical device marketed and sold in the United States. Because of its regulatory role, the agency has its own center called the Center for Devices and Radiological Health. Medical device manufacturers must go through several steps in order to market and sell their products in the United States.
Registration
Any company, including foreign manufacturers, that wants to market and distribute medical devices in the United States must register with the FDA. The agency requires companies to register each year. Registration allows the FDA to better prepare and respond to public health emergencies by knowing where medical devices are made, according to the agency's website.
Listing
Any medical device manufacturer or distributor must list their devices in addition to registering their companies. The FDA provides a list of companies who must register their products on its website. These include: manufacturers, commercial distributors of the device, including contract manufacturers and sterilizers, those who repackage and re-label, specification developers, those who re-process single use devices, those who re-manufacture the device, those who manufacture accessories and components for the device which are sold directly to end users and U.S. manufacturers of export-only devices.
Premarket Approval or Notification
FDA regulations stipulate that medical devices be proved safe before they can be put on the market. The device must pass the FDA's pre-market approval test. Some devices are exempt from this requirement, including those which do not sustain human life, do not prevent any injury or damage to humans, or which will not cause great harm to humans. If manufacturers can show that their device is substantially equivalent to a similar apparatus on the market, the manufacturers do not need to gain pre-market approval. However, they still need to notify the FDA that their products are safe.
Quality Systems Regulation
Every U.S. manufacturer the FDA regulates must follow current good manufacturing processes. Because the agency also regulates medical device manufacturers, medical device factories are required to have current good manufacturing processes in place. A good manufacturing process would be ensuring that a work environment is sterile to prevent contaminating the device, for example. A wide range of medical devices exist, so the processes do not specify how a device must be produced. Rather, they assure that the device is manufactured at a certain standard and quality, and that medical devices will not harm patients. The FDA notes on its websites that manufacturers must develop processes which are relevant to the products they produce.
Labeling
Medical devices, as with any other FDA-regulated product, must be labeled properly before they can be marketed. Proper labeling, according to the FDA, means that any materials associated with the device, such as pamphlets, containers or other product information, must be accurate. It also must include the manufacturer's address. The FDA's labeling standards also require that manufacturers list other possible uses other than those intended. Medical device labeling also must contain instructions for the product's use. All labeling must be in English.
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