Medical, Electronic & Radiological Devices
Medical devices must meet all FDA regulations prior to being imported into the United States. The first things foreign medical device manufacturers should know is that FDA does not recognize regulatory approvals from foreign countries.
The term medical device under the Food Drug and Cosmetic Act (FDCA) refers to machines, instruments, implants, in vitro reagents, and similar or related articles which are 1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 2) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Medical devices fall into one of the following three classes. Class 1 medical devices are those with the lowest level of risk associated with them. Class 2 medical devices carry greater risk. Class 3 medical devices carry the greatest risk.
Identifying or obtaining the correct medical device classification is essential for all medical device manufacturers and distributors. Most Class 1 medical devices require only that the foreign manufacturer be registered with FDA under the FDA Medical Device Establishment Registration regulations and that the registered establishment submit a medical device listing to FDA identifying the device it is distributing in the U.S. market. Most Class 2 medical devices (and a few Class 1 medical devices) are subject to an FDA Pre-Market Notification (PMN) or FDA 510(k) submission and review process. The PMN or 510(k) process involves submitting to FDA evidence that a medical device is substantially equivalent to a device that has been previously and lawfully marketed in the U.S. under a PMN or 510(k)).
Most Class 3 medical devices are subject to the FDA Pre-Market Approval (PMA) process, which is substantially more complicated, costly, and comprehensive with regard to the evidence of safety and effectiveness FDA requires.
Like all other FDA regulated articles, medical devices must be properly labeled, must be manufactured according to specific standards, must obtain all pre-clearances before being imported into the U.S., and must be manufactured in appropriate (registered) facilities. Foreign medical device manufacturers must register with FDA under the FDA Device Establishment Registration regulations and must appoint a U.S. Agent for FDA purposes.
ELECTRONIC & RADIOLOGICAL DEVICES
The FDA regulates radiation emitting electronic products whether or not they have a medical purpose.
FDA gained authority to regulate all electronic products that emit radiation under the Radiation Control for Health and Safety Act of 1968 (Rad Health Act).
FDA regulated electronic products include any manufactured or assembled products (along with any component, part or accessory of such products) which contain or act as a part of an electrical circuit and emit radiation of any kind.
Many radiation emitting electronic products are also medical devices. In those cases, the electronic product must comply with both the Rad Health Act and with the Food Drug and Cosmetic Act (FDCA) governing medical devices.
To give an idea of how broad FDA’s jurisdiction is, we’ve included a sampling of the electronic products regulated by FDA below.
Television receivers, Computer monitors, X-ray machines (including medical, research, industrial, and educational), Electron microscopes, Alarm systems, Microwave ovens (devices that generate microwave power), all lasers (including low power lasers such as DVD and CD readers/writers/players) and other light emitting devices (Infrared and Ultraviolet).
Companies that manufacture or import electronic products subject to an FDA performance standard are required to submit various electronic product reports to FDA, the most basic and important of which is called the Electronic Product Initial Report.
When a manufacturer or importer submits an Electronic Product Initial Report to FDA, the FDA’s Center for Devices and Radiological Health (CDRH) reviews the electronic product report to ensure the information demonstrates that the manufacturer’s electronic product meets any applicable performance standard, and that the process for manufacturing or assembling the electronic product is likely to repeatedly produce complying electronic products. If the product is considered safe, an Accession Numbers to the manufacturer that submitted the electronic product report is issued; this “number” is necessary for importing electronic products into the U.S.
There are specific certification and labeling requirements that apply to electronic products, and the user manual is a critical piece of information for consumers. FDA requires electronic product user manuals to include many specific warnings and declarations, as well as include clear, complete and concise instructions for use.