This alert presents a brief overview of medical device approval and regulation in the United States.  We have emphasized areas of particular interest to foreign manufacturers and importers of medical devices into the United States.

Medical Devices

Medical devices are subject to U.S. federal law and regulated by the Food and Drug Administration (“FDA”).  The Food, Drug, and Cosmetic Act defines “device” broadly and, in practice, the term encompasses a wide range of products from simple tongue depressors to complex cardiac pacemakers.

Registration and Listing with FDA

FDA requires device manufacturers—including foreign manufacturers—to register their establishment and list their device with FDA.  Foreign manufacturers must also appoint a U.S. agent to represent them in the United States.  Foreign manufacturers who seek to market their devices in the United States may wish to open a U.S. subsidiary, but this is not an FDA requirement.

The Classification of Medical Devices

FDA classifies medical devices into Class I, II and III and regulates them based on their classification.  Class I devices are simple, low-risk devices, such as tongue depressors, bandages, and dental floss.  Class II devices are moderate-risk devices, such as catheters, syringes, test kits, and hearing aids.  Class III devices are complex devices, such as cardiac pacemakers.

Introducing a Medical Device into the U.S. Market

Many Class I devices can be marketed in the United States—after registration and listing—without further authorization from FDA.  These devices are subject to FDA supervision and oversight, including what are known as “general controls,” but they are exempt from the regulatory pathways described below.

There are two main regulatory pathways for bringing a new medical device to the U.S. market:  the Premarket Notification 510(k) process and the Premarket Approval process.  The Premarket Notification 510(k) process is an abbreviated process, mainly used for non-exempt Class I devices and Class II devices.  The Premarket Approval process is a more rigorous process, mainly used for Class III devices.

The Premarket Notification 510(k) process allows a manufacturer to obtain marketing clearance by showing that its device is substantially equivalent to, and therefore is as safe and effective as, a device already on the market, known as a “predicate.”  If FDA finds substantial equivalence, it will issue an order, in the form of a letter, stating that the device can be marketed in the U.S.  Technically speaking, this order does not “approve” the device, but “clears” it for commercial distribution.

The Premarket Approval process is a more stringent process, which requires the applicant to submit robust laboratory and clinical data demonstrating that the device is safe and effective for its intended use.  FDA conducts a rigorous review of the data before deciding whether to approve the device for marketing.  If FDA is not satisfied with the submitted data, it can ask the applicant to conduct additional studies, either pre- or post-approval.

There is another regulatory pathway, known as the “de novo” pathway, for novel devices of low to moderate risk.  An applicant may request de novo classification in two circumstances:  (1) upon the applicant’s determination that its device has no legally marketed predicate or (2) after FDA rejects a 510(k) application upon a determination that the device is not substantially equivalent.

Regulatory Requirements

FDA regulates medical devices throughout their lifespan, from initial development to post-approval marketing.  Device manufacturers must comply with federal laws and FDA regulations relating to, among other things, the conduct of clinical studies, the manufacturing of the device, the labeling of the device, and the monitoring of the device once it hits the market.

Clinical Studies:  Manufacturers conduct clinical studies to obtain data that will be necessary for FDA clearance or approval.  To conduct a clinical study prior to clearance or approval, the manufacturer or sponsor must obtain an investigational device exemption from FDA.  In conducting the study, the sponsor must follow regulatory requirements and Good Clinical Practices.

Quality System Controls:  A federal regulation, known as the Quality System regulation, governs the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices.  The regulation embodies Current Good Manufacturing Practices, which FDA requires manufacturers to tailor to their specific devices.

FDA Inspections:  FDA may inspect manufacturing facilities—including those located abroad—to ensure compliance with the Quality System requirements.  If a manufacturer refuses to permit an FDA inspection, the devices manufactured at that facility will be deemed “adulterated”—which means that they cannot be marketed in the United States.

Labeling:  Medical devices must also comply with certain labeling requirements.  This includes both the label affixed to the device and any descriptive and informational literature that accompanies the device.  If the labeling of a medical device contains false or misleading statements or otherwise fails to meet FDA requirements, the device may be deemed “misbranded”—which means that it cannot be marketed in the United States. 

Post-Marketing Surveillance:  Manufacturers and importers are required to report adverse events to FDA when they become aware that their device (1) may have caused or contributed to a death or serious injury, or (2) malfunctioned in a way that might cause death or serious injury.  FDA also requires manufacturers and importers to maintain complaint files so that they can evaluate whether a complaint is a reportable adverse event.


Medical device approval and regulation is a more complex topic than can be presented in this brief overview.  For further information or for help with any of the issues described above, please contact any of the Hughes Hubbard lawyers listed below.