Medical device

FDA Regulatory Framework Overview for Promotion of Medical Devices

An overview of the FDA regulatory framework for the promotion of medical devices

April 18, 2022
Rory A. Carrillo
Principal Consultant


Drugs, Biologics and Device advertisement and promotional labeling regulations are generally governed by:

The Food, Drug, and Cosmetic Act (FDCA) state that a “drug or device shall be deemed to be misbranded. . . if its labeling is false or misleading in any particular.” The statute defines labeling to include any “written, printed, or graphic matter” (1) upon a drug itself, its immediate or other “containers or wrappers,” or (2) “accompanying such article.”

One common misunderstanding is that the FDA governs all “promotional” regulations. However, this is not true. In fact, the FTC is the agency that typically governs advertising and promotional labeling i.e. ads and promos for products (under Sections 12-15 of the Federal Trade Commission Act). But, the FTC and FDA have an agreement that the FDA will regulate device and promotional labeling for all drugs and biologics, but will have a restricted governance for medical devices. Specifically, FDA governs medical device labeling, but generally not advertising - except for restricted medical devices (e.g Most Class III devices and other Class I and II like hearing aids). Thus, the 21 CFR 201 and 202 are mostly focused on drugs and biologics.  

Additionally, FDA has not promulgated any regulations relating to medical device promotion (other than restricted devices), nor has it issued any final or draft guidance documents specific to medical device promotion or advertising. Four current draft guidances address promotion and advertising of both prescription drugs and restricted medical devices. 

  1. Presenting Risk Information in Prescription Drug and Medical Device Promotion
  2. Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices 
  3. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
  4. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices 

FDA frequently updates or adds new guidances. Additional guidances related to advertising and promotion may be found on the FDA website (see here), but most of these are not related to medical devices - at least according to the guidance scope(s). However, it may be diligent to be aware of the policies governing drugs or biologics as it sheds light on how the FDA might apply similar policies to medical devices. 

Lastly, generally speaking, FTC’s standards for “false advertising” in many respects track the requirements in FDA’s prescription drug advertising regulations, but there are some differences. 

A couple of those differences are:

  • FTC requires certain health-related advertising claims to be substantiated by “competent and reliable scientific evidence,” a standard generally recognized as more flexible and “allowing a broader range of claims” than FDA’s substantial evidence standard. 
  • FTC does not require “fair balance,” as that term is strictly defined by FDA, but holds advertisements to a “reasonable” standard of truthfulness. Therefore, non-restricted device advertisements may be subjected to different standards than those FDA would seemingly apply to restricted device advertisements.

For more details of the statutory and regulatory requirements for labeling and advertising, see the "Attachment" in this FDA guidance -

Although the regulations discussed throughout this document were promulgated in the context of prescription drug advertising, the guidance they provide on what FDA considers false or misleading in promotion has broader applicability. For example, promotional pieces that fail to present a balanced view of the risks and benefits of a product are generally considered to be false or misleading and also generally fail to reveal material facts about the product being promoted. Because both labeling pieces for drugs and devices, and advertising pieces for prescription drugs and restricted devices, are considered to misbrand a product if they are false or misleading or fail to reveal material facts, drug and device manufacturers should take into account the guidance provided by these regulations when developing promotional labeling and advertising piece for their products.

An example of regulations that may apply but are not specific to medical devices is the following guidance related to post-market submissions and promotional material -

Federal Trade Commission (FTC)

FTC is an independent, bipartisan federal agency whose primary mission consists of two elements: to protect consumers from deceptive and unfair business practices and to promote competition among businesses. Consistent with the authority granted in the Federal Trade Commission Act (FTC Act), FTC pursues enforcement actions against businesses that publish false and misleading advertisements for products. In fact, the FTC Act prohibits the dissemination of false advertisements “by any means, for the purpose of inducing...the purchase...of food, drugs, devices, services, or cosmetics” and declares false advertising is an unfair or deceptive trade practice.

As previously mentioned, most of the jurisdiction on device promotional labeling will come from the FTC. As a result, we are unable to provide further guidance with respect to FTC regulations as we are not experts regarding FTC laws. However, the resources below should be able to point you to appropriate regulations under FTC jurisdiction as it relates to medical device advertisements and promotional labeling. 


Deceptive Ads

Disclaimer - This post intended for informational purposes and does not constitute legal information or advice. The materials are provided in consultation with US federal law and may not encompass state or local law.