Medical device labeling includes all materials accompanying a device—labels, manuals, brochures, and even advertising. Learn FDA requirements under 21 CFR Part 801 to ensure accurate, compliant communication and avoid misbranding risks.
Medical device labeling encompasses far more than just the sticker on a product – it includes all written, printed, or graphic materials associated with the device and intended to communicate its identity, use, or safety information. The U.S. Food and Drug Administration (FDA) draws a distinction between a “label” (the information on the immediate container of the device) and “labeling” (all labels and other accompanying materials) as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act). In fact, Section 201(k) of the FD&C Act defines a label as “any display of written, printed, or graphic matter upon the immediate container of any article,” whereas Section 201(m) defines labeling broadly as “all labels and other written, printed, or graphic matter” on the device or its packaging or that accompanies the device at any time while it’s on the market. This means not only the device’s package labels, but also instruction manuals, brochures, marketing leaflets, and other materials provided with the device are all considered part of its labeling. Importantly, the term “accompanying” is interpreted liberally by FDA – even promotional materials like posters, pamphlets, or digital content distributed about the product can be deemed labeling.
Because of this broad interpretation, advertising for a medical device often falls under FDA’s labeling regulations. As one court famously noted, “Most, if not all advertising, is labeling” in the eyes of the law. Any printed or online advertisement that supplements or explains a device – including website content, social media posts, and brochures – may legally be considered part of the device’s labeling if it “accompanies” the product. Therefore, companies must ensure consistency and compliance not just on the physical label, but across all informational and promotional materials for the device.
FDA’s core labeling requirements are primarily found in 21 CFR Part 801, which lays out the general device labeling rules. These regulations cover everything from basic label content (like the manufacturer’s name and address) to specific cases (such as in vitro diagnostics and use of symbols). Other parts of Title 21 address related issues – for example, Part 809 for IVD devices and Part 830 for Unique Device Identification (UDI) – but 21 CFR 801 is the central regulation defining what must (and must not) appear on medical device labeling. Failure to meet these requirements can render a device “misbranded,” meaning it violates Section 502 of the FD&C Act, which can lead to FDA enforcement actions. At a high level, a device is considered misbranded if its labeling is false or misleading in any way or if it fails to contain required information in a prominent and clear manner.
In summary, compliant labeling is a foundational part of medical device regulation. It ensures that healthcare providers and patients receive accurate, essential information about a device’s use, risks, and manufacturer. Understanding the FDA’s definitions of label vs. labeling and the scope of materials governed by labeling rules is the first step in achieving compliance. The sections that follow will delve into the specific elements required on device labels, the regulations on promotional claims and advertising, and best practices to avoid the common pitfalls that can lead to misbranding.
