Selling Medical Devices to Consumers in the USA

Selling Medical Devices to Consumers in the USA

Definitions

Over-the-counter (OTC): Products that can be sold directly to consumers, without prescription.

Direct to consumer (DTC): Advertising to consumers instead of to healthcare professionals, etc.

Home use: Device suitable for use by a consumer user while under the care or direction of a licensed healthcare practitioner. A prescription is required for the consumer to purchase a “home use” device. It is sometimes called “prescription home use”.

Regulatory Framework

Food and Drug Administration (FDA)

The FDA is the principal agency with authority over medical device labelling, promotion and advertising. The FDA is responsible for protecting the public health by assuring the safety effectiveness and security of human and veterinary drugs, vaccines and other biological products, medical devices, food products, cosmetics, dietary supplements, tobacco products and products that give off radiation. The FDA’s authority primarily flows from the Federal Food, Drug, and Cosmetic Act (FDCA)2.

The FDCA, along with the regulations and guidance documents issued by the FDA to implement and interpret the Act, governs the labelling, promotion and advertising of pharmaceutical drug and medical device products. These include prescription drugs and devices, over-the-counter (OTC) drugs and devices, vaccines, blood products and other biological drug products.

CDRH and CBER

Medical devices sold in the US are generally regulated by two FDA Centers: the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

CDRH is responsible for regulating firms that, among other things, manufacture, repackage, re-label, sterilize, distribute, import and/or export medical devices. Examples of medical devices include surgical instruments, implantable devices, diagnostic equipment, clinical laboratory tests and medical radiation emitting products (e.g., lasers, x-ray systems and ultrasound equipment).

CBER regulates some medical devices used in the collection of whole blood and other blood products. Examples include cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply.

General Information

Only medical devices that have been cleared for “over-the-counter” (OTC) use or “home use” may be advertised and sold directly to consumers. All other devices may only be sold on the order of a licensed healthcare professional (via a prescription or an order from a licensed healthcare professional is a requirement).

As with advertising to the healthcare industry, advertising to consumers must be truthful and non-deceptive, advertisers must have evidence to back up their claims, and advertisements cannot be unfair. Because consumers are generally less technically educated than those in the healthcare industry, both FDA and Federal Trade Commission (FTC) regulate advertising and sale to consumers closely to prevent risks to the public health.

The FTC is charged with regulating the advertising of many medical devices under sections 12 to 15 of the FTC Act, which prohibit false or misleading advertising of certain products that the FDA regulates3. Still, the FDA has statutory authority to regulate advertising of restricted devices (including prescription-only devices), as well as misbranding provisions related to restricted devices4. Neither the FDA nor the FTC requires the submission of medical device advertisements for pre-approval.

Advertising to Consumers

If a device has been cleared by the FDA’s 510(k) process for OTC or prescription home use, it can be advertised directly to consumers. Such advertising must be truthful and accurate and not misleading in any way.

The advertisement of restricted devices falls within FDA’s statutory authority while the advertising of non-restricted devices falls largely under the authority of the FTC. Under the FDCA5, manufacturers, packers and distributors who advertise restricted devices distributed or offered for sale in the US are required to include “a brief statement of the intended uses of the device and relevant warnings, precautions, side effects and contraindications” in the advertisements.

Consumer advertising of restricted devices, especially information relating to a device’s intended uses, limitations, warnings, precautions, side effects and contraindications, should be presented using consumer-friendly language. Discussions of risk should be presented in a balanced manner. For these reasons, in the case of a restricted device, advertisements using technical jargon or terms understood only by experts would likely be subject to challenge on the grounds that the advertisement failed to provide an adequate brief statement.

Exempt Communications

Generally speaking, for the FDA to assert regulatory authority over restricted device promotion, the device must be identified expressly or by implication. There must also be something communicated about the product. When only one of these two elements exists in a promotional item, it is not considered to be promotional and is not regulated by the FDA.

As a consequence, there exist certain categories of company-sponsored communications that are exempt from the FDA’s labelling and advertising requirements. Such communications do not need to be fairly balanced and do not need to be accompanied by a brief summary (if advertising):

  • Help-Seeking and Disease Awareness Communications6 – Communications exempt from the FDA’s labelling and promotion requirements include messages that:
    • discuss a disease or health condition;
    • include “see your doctor” (if aimed at consumers);
    • encourage awareness of disease (if aimed at healthcare practitioners);
    • do not mention a particular drug or device; and
    • do not include any representation or suggestion relating to a particular drug or device7

Note: if the product is the only drug or device in its class, promoting it may be unlawful even if the it is not identified by name8.

  • Reminder Messages – These messages only call attention to the name of the product. They do not include any information about indications, dosage or use, or make any other representation about the product.9
  • Institutional Promotion – These are promotions about the company itself, its research interests and its expertise. Institutional promotions may identify areas in which the company is conducting research, but in order to be exempt from FDA requirements, they may not identify a drug or device by name10

Note : If disease awareness and reminder ads are used in close proximity to one another, FDA will consider them to be labelling and thus subject to FDA jurisdiction.

Comparative claims

The FDA’s regulations state that “among representations in the labelling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.”15 Comparative claims can be expressed; for example, as “Our product is safer and/or more effective than another brand of product.” Comparative claims can also be implied, which tend to be vague assertions of superiority over another product.

The FDA tends to scrutinize more closely advertising or promotional materials that compare one device with another because the agency considers these to be more likely misleading. For example, the FDA expects comparative claims to be supported by reliable scientific data, which may include a study that directly compares the products. Any study discussion must point out the positive and negative data from the study.

The FTC requires sufficient substantiation of claims made in medical device advertising. Comparative claims may need to be supported by balanced, scientific clinical studies or other controlled head-to-head analyses that support claims of superiority. Also, comparative advertising should not involve discussions or comparisons of a competitor’s device with respect to uses for which the competitor’s product is not intended, cleared or approved.

Press Releases

The FDA asserts regulatory authority over company press releases. If a company press release identifies a device, the FDA can treat such communications as promotional labelling. As such, product-specific press releases should otherwise meet FDA’s requirements discussed above.

Press releases discussing clinical results should factually present the information and not characterize the clinical results.

Coupons, Vouchers, Samples and Other Remuneration

FDA regulation of manufacturer-sponsored offers, whether to patients or healthcare professionals, like all manufacturer-sponsored communications, must be truthful, consistent with the FDA- sanctioned indications for use, fairly balanced and not misleading.

CE Mark and Medical Devices

Marketing of drugs and medical devices without the CE mark is not prohibited in the US as long as the applicable FDA requirements are satisfied. Conversely, bearing the CE mark does not eliminate the need for compliance with FDA requirements. However, because the requirements for obtaining the CE mark are similar to FDA requirements in many respects, having the CE mark would be helpful in meeting the FDA requirements.

Before and After Images

While there are no specific requirements applicable to the use of “before and after” images in labelling and advertising, this practice may be subject to higher scrutiny as to whether such images are false and misleading.

Product Testimonials

Promotional labelling or advertising using testimonials is acceptable in general. However, such testimonials may be scrutinized to ensure that they are not false or misleading, and do not suggest an unapproved use. The advertiser may not use a testimonial to make claims it could not otherwise make in the absence of a testimonial. Pursuant to FTC guidance, advertisements containing testimonials must reflect honest opinions, findings and beliefs of the endorser.16

Selling to Consumers

Only devices that have been cleared by the FDA’s 510(k) process for OTC use or for prescription home use can be sold directly to consumers.


To purchase a device that has been cleared for prescription home use, the consumer must provide a prescription from a licensed healthcare provider. The manufacturer or distributor is responsible for verifying the legitimacy of the prescription before providing the device to the consumer.
Mobile health apps occupy a grey area, where the regulations that apply depend on the functionality of the app and its intended users, sponsors, health-related claims, etc. The FTC offers an interactive tool to help app developers determine which regulations apply to their apps.

Selling on the Internet (E-Commerce)

The FDA monitors internet sites regularly and works with the Federal Trade Commission (FTC) to stop illegal advertising and sales. The FTC Act broadly prohibits unfair or deceptive advertising, so that the FTC Act applies to any medium, including the Internet.

The FDA requirements for the labelling and promotion of FDA regulated products were developed prior to the Internet. However, the FDA has taken the position that the requirements applicable to print advertisements in journals, newspapers and printed promotional labelling apply to online media as well. Therefore, the FDA and FTC do not discriminate between traditional advertising and selling practices and e-commerce.

The same FDA requirements apply regardless of the space and characters available, such as on a Facebook page, sponsored link from an Internet search engine, microblogging site such as Twitter, or website “widget.” If the company’s sponsored message identifies the FDA-regulated article by name and makes any representation about it, the normally applicable requirements for a drug or device product otherwise apply to the message.

The FTC has published a related guidance, Advertising and Marketing on the Internet: Rules of the Road11. In 2014, the FDA further released three draft guidance documents pertaining to the internet and social media platforms12, 13, 14.

As with other medical records or “protected health information”, consumer privacy must be protected online, and commercial websites must provide information on what information will be collected, how the information will be used, and how the consumer’s health information privacy will be protected.

Disseminating Information on New/Unapproved Uses (“Off-label Use”)

Information on new or unapproved uses cannot be provided to consumers. Consumers can only be provided with the cleared indications for use.

Approval/Clearance of Consumer Advertising

The FTC is charged with regulating the advertising (as opposed to the labelling) of many medical devices under sections 12 to 15 of the FTC Act, which prohibit false or misleading advertising of certain products that the FDA regulates.17 Still, the FDA has statutory authority to regulate advertising of restricted devices (including prescription-only devices), as well as misbranding provisions related to restricted devices.18 Generally speaking, consumer advertisements for 510(k)-cleared devices do not require FDA nor the FTC submission for pre-approval.

Because devices approved via Premarket approval (PMA) are by definition “high risk” devices, or are life-sustaining, life-supporting, or implanted into the body, they may not be advertised or sold directly to the consumer.

Regulatory Authority and Enforcement

As with advertising to the healthcare industry, both FDA and FTC have authority over advertising and sales to consumers.

FDA Authority

FDA regulates direct-to-consumer advertising under its labelling jurisdiction. As stated previously, FDA determines during the product clearance process if a product can be sold OTC or for prescription home use.

FDA Enforcement

FDA uses untitled letters and Warning Letters to enforce labelling compliance. FDA can issue an injunction or restraining order preventing further sale/distribution of a device found to be illegally sold to consumers and may bring the offending manufacturer or distributor to court where civil and/or criminal fines and/or penalties may be levied.

FTC Authority

The Federal Trade Commission (FTC) has primary jurisdiction over device advertising found at 15 USC 45 (Unfair methods of competition) and at 15 USC 52 (Dissemination of False Advertisements) under the Federal Trade Commission Act.

FTC Enforcement

The FTC enforces its jurisdiction under 15 USC 53, which gives it the authority to issue injunctions and/or restraining orders to anyone who disseminates false advertisements.

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