Medical Devices

FDA Medical Device Regulation in the U.S.

Medical devices must meet all FDA regulations prior to being imported into the United States. One of the first things foreign medical device manufacturers must be aware of 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 instruments, machines, implants, in vitro reagents, and similar or related articles, including component parts or accessories 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 three classes. Class 1 medical devices are those with the lowest level of risk associated with them. If a Class 1 medical device failed or became defective, there would be no significant injury or harm to the patient or user. Class 2 medical devices carry greater risk. If a Class 2 medical device failed or became defective, there would be a risk that the patient or the user could be injured or harmed. Class 3 medical devices carry the greatest risk. If a Class 3 medical device failed or became defective, there would be a risk of serious injury or death to the patient or the user. FDA classifies medical devices and, in many cases, has issued regulations stating the classifications and requirements for medical devices. However, as medical device technology advances, in many instances a new medical device does not fall easily into an existing medical device classification or category. Therefore, there is a regulatory process in which medical device manufacturers and distributors can ask FDA to classify a new medical device.

Identifying or obtaining the correct medical device classification is critical 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 predicate device (a device that has been previously and lawfully marketed in the U.S. under a PMN or 510(k)). A few Class 3 medical devices are also subject only to the FDA 510(k) or PMN review regulations. 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.

FDAImports.com, LLC represents many medical device manufacturers and distributors performing device classifications, regulatory reviews of changes or modifications to previously cleared medical devices, preparing, filing, and prosecuting FDA PMNs and medical device 510(k) submissions with FDA, and providing guidance and counsel in preparing for or reacting to FDA medical device inspections. Identifying the proper clearance or approval requirements is the first major step for any medical device manufacturer or distributor entering the U.S. market. FDAImports.com, LLC helps medical device companies from around the world find The Way Through what can seem like a very complicated FDA regulatory review process.

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. FDAImports.com, LLC acts as U.S. Agent for foreign medical device clients, ensuring that all required data is submitted to FDA prior to shipping medical devices to the U.S. and that all substantive clearance, labeling, and listing requirements are also met.

Importers of medical devices must also register with FDA as device establishments acting as medical device initial distributors. FDA expects U.S. importers to understand and ensure compliance with FDA laws and regulations related to medical devices, medical device manufacturing, and medical device clearances (510(k)s) and FDA approvals (PMAs) when required. FDAImports.com, LLC represents medical device importers, showing them The Way Through the FDA and Customs importation process for importing medical devices.