There are tens of thousands of medical devices being advertised and promoted in the U.S. The Food and Drug Administration (FDA) has statutory authority to regulate the advertising and promotion of “restricted” medical devices as well as any medical devices that are not authorized by FDA for sale or distribution for their intended use. A “restricted device” is a device that can only be sold, distributed or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

Devices that are not authorized for marketing include experimental (or investigational) devices as well as approved or cleared devices that are marketed for uses not on their approved or cleared labels (“off-label uses”). In both cases, the unauthorized intended use of the device would render the device “misbranded.”

A medical device is misbranded if its advertising is “false or misleading” in any way. The false and misleading standard also applies to a product’s labeling and “other descriptive printed matter.” A device is also misbranded if its label does not contain certain required information, such as: (1) the generic name of the product in type at least half the size of the trade name; (2) a brief statement of the intended uses and warnings, precautions, side effects and contraindications; and (3) when needed, a description of the device’s components. (21 U.S.C. § 352(q)).

By way of background and to appreciate the full scope of FDA’s authority over products that are considered to be medical devices, it is interesting (if not mind-boggling) to review the broad statutory definition of a medical device. A medical device is defined as:

“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) 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

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. (21 U.S.C. 301(h)(emphasis added).”

From this definition, it’s clear that “intended use” is the key in determining regulatory status and compliance. FDA determines the intended use of a medical device by looking at a wide body of evidence, such as: “labeling claims, advertising matter, or oral or written statements” or circumstances that show the medical device is “with the knowledge of [the manufacturer] offered and used for a purpose for which it is neither labeled nor advertised.” (21 C.F.R. § 801.4) (emphasis added). In determining whether labeling or advertising is misleading, the FDA considers everything: statements or any other representations, explicitly made or implied by “word, design, device or any combination” of these, as well as the “extent to which the labeling or advertising fails to reveal facts that are material, such as information about the risks from using the device either on or off-label. (21 U.S.C. 301(n)).

Device advertising is different from drug advertising. The most obvious difference is the complete absence of any regulations to guide medical device companies in developing their advertising. By contrast, the FDA has an extensive and detailed regulation (21 C.F.R. Part 202) that sets out the requirements as well as the prohibitions for drug advertising.

For example, FDA regulations require drug advertising to include fair balance between the benefits and risks of the product, as well as specific language and size of print. The drug regulations explicitly prohibit, among other things, unsubstantiated efficacy, comparability and superiority claims. Although the same detailed regulations have not been imposed by FDA, the agency applies many of these same restrictions on medical devices.

Although the FDA is prohibited from the regulation of “commercial free speech” under the First Amendment, and may not impose preapproval requirements for either drugs or devices, the FDA has carved out an exception for drugs when the drug is approved through an accelerated pathway or when the FDA finds that the drug pose such risks that preapproval of advertising is needed to protect the public health. By contrast, the FDA has not imposed a similar preapproval review for medical devices.

The FDA enforces the advertising and promotion of medical devices in a variety of ways. The first and obvious way is by reviewing labeling and other publicly disseminated materials. The FDA can find advertising and promotional materials from any source or by any means, such as reading product web pages and surfing the Internet to learn how a device is being used by consumers. In addition, FDA compliance reviewers attend trade shows and scientific/medical conferences, read periodicals and inspect company facilities.

Of great concern to most companies is having a level playing field when competing in the market. To this end, many companies file trade complaints with the FDA in which they detail violations, provide copies of the violative materials and analyze the legal basis for FDA to take an enforcement action. Such letters attempt to make it as easy as possible for FDA to take action. The FDA states that it reviews all complaints, but whether the FDA will take action is never revealed. Nor will the FDA inform the complainant when it does take action. To a lesser extent and without as much analysis, the FDA receives complaints from healthcare providers, and sometimes consumers.

To leverage its limited resources, the FDA focuses first on higher risk medical devices in addition to unapproved medical devices that have the potential to lead to injury. For example, if the agency must make a choice, the FDA would be more likely to focus on cardiac implants instead of exercise equipment.

From the small amount of information and guidance the FDA has offered to date, we know how the FDA would view certain statements and representations. For example, companies are permitted to state that a medical device is approved if, in fact, the device has been “approved” under a premarket application (PMA), which is required for high risk devices. However, the FDA does not permit the use of the phrase “FDA approved” when referring to a device brought to market via the 510(k) notification process.

A 510(k) device is generally of low to moderate risk. Despite the premarket submission requirements, a 510(k) medical device is not “FDA-approved.” Rather, such a device is “cleared” by the agency.

With respect to PMA devices, a manufacturer must demonstrate the safety and efficacy of its medical device typically with clinical studies. A manufacturer of a 510(k) medical device only needs to show that the device is substantially equivalent to a legally marketed 510(k) device, referred to as the predicate device. If substantial equivalence is shown, the device is considered as safe and effective as the predicate without presentation of independent evidence of safety and effectiveness. To say a 510(k) device is approved would be false and misleading and, thus, prohibited.

The world of medical device regulation is complex and often maddening. But a surefire way to show your familiarity with medical devices is to be sure to refer to a 510(k) device as cleared for its intended use and a PMA device as approved.

Areta L. Kupchyk

areta-kupchyk-nixon-peabodyAreta Kupchyk is a partner with Nixon Peabody LLP who provides counsel to clients on the U.S. Food and Drug Administration (FDA) regulation of drug, medical device, biotechnology, and biologic products.
Formerly an Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation at the FDA, Ms. Kupchyk possesses a nuanced understanding of FDA regulatory procedure that allows her to insightfully navigate clients through all phases of product development, review, and approval, including obtaining approvals with market protections such as three-year market exclusivity for new indications requiring clinical studies, five-year market exclusivity for new chemical entities, and seven-year market exclusivity for orphan drugs.


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