A Guide to Meeting FDA Regulations while Advertising and Promoting Medical Devices

In this blog, we will summarize regulations, guidelines and trends affecting the advertising and promotion of medical devices.

As a quality and compliance leader in the medical device sector, this post will help you understand the intended use and labeling principles as applied to the advertising and promotion of medical devices. We will also highlight current expectations and FDA’s rules as applied to online marketing, websites and social media platforms. Overall, we will cover the following – good promotional practices, key labeling principles and a risk-based framework for labeling.

It is important to note that the FDA expects that devices be promoted consistently with cleared and approved labeling with claims that remain truthful. The marketing pathways include Premarket Notification (510(k)), Premarket Approval (PMA), De Novo Classification Request, Exempt, Product Development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics License Application (BLA).

Labeling Basics

The FDA-required labeling serves the purpose of communicating all essential information needed for the safe and effective use of the product. Therefore, medical device companies must make sure the labeling is not false or misleading. The general scope of labeling requirements for medical devices is described in 21 CFR Part 801.

FDA recognizes two types of labeling – promotional and FDA-required labeling. FDA determines if a medical product is safe and effective for use under the conditions recommended, prescribed, or suggested in the proposed labeling submitted with the product’s marketing application or during the classification process.

FDA evaluates whether the conditions of use in the proposed labeling are supported by evidence of safety and effective use of the device, for its intended purpose.

To understand the basics of labeling, FDA has clearly defined different parameters that help medical device advertising.

What is Labeling According to the FDA?

Labeling is anything written that supplements or explains the product (both on the medical product and its container/package).

Information in the label is provided by the manufacturer and reaches the customer, doctor or patient, before, with, or after the product.

FDA considers the following as labels: in-house newsletters, letters, films, CDs, DVDs, in-service, testimonials on medical practitioners, labels, sell sheets, tradeshow material, posters/billboards, broadcast voicemail, and educational materials/CME. This also includes brochures, booklets, mailing pieces, social media posts, whitepapers, content on the website, blogs, and instructions for use documents.

Rules for Medical Device Marketing & Promotion

The FDA believes that the firm's information about their medical products must be truthful and non-misleading, with the necessary background and contextual information being provided to enable payors to make informed decisions. As a result, FDA regulates the labeling of medical devices and advertising of restricted devices. To that end, FDA looks at intended use – whether the manufacturer’s information stays within the approved or cleared claim. The recommendations mentioned in these FDA guidance documents apply to the promotional materials directed to the consumers and healthcare professionals. This includes ads and micro-content on the internet and social media platforms.

There is also a responsibility on the manufacturer to set up processes for the following:

• Correcting misinformation from independent third-parties, who may be presenting wrong information
• Presenting risk information with clarity
• Not overstating the benefits

Facts & Claims

The FDA’s responsibility is to ensure that companies focus on their responsibility towards miscommunication of information while promoting or advertising. Broadly, there are three categories that need utmost care:

• Statements of Fact – Easy to verify statements that are obvious and truthful may not need independent substantiation.
• Comparative Claims – Statements comparing products to competitors require substantiation.
• Clinical Claims – Statements that relate to the performance of the product in patients must be supported by clinical evidence.

Advertising and Promotional Materials – A Few Cardinal Rules

The FDA scrutinizes every statement laid out as part of advertising and promotion of medical devices.

Medical device manufacturers should follow these rules to ensure complete compliance with the FDA:

• Must comply with local laws and regulations
• Must always be truthful and not misleading or deceptive
• Must have adequate support of claims
• Must be allowed only for the uses cleared or approved by the regulatory body in the specific country

Good Promotional Practices

The FDA can research advertising and promotional materials from various sources, such as reading product web pages and internet searches to learn how consumers use a device. FDA’s compliance reviewers also attend trade shows and medical conferences, read periodicals and inspect company facilities. For instance, comparative superiority claims without head-to-head testing or promotion without proper FDA approval are strictly prohibited.

To remain compliant, here are some of the best practices companies can follow:

• Provide fair balance and required context on platforms (even on those with space restrictions; lack of space does not mean information can be missed out)
• Monitor user-generated content for Adverse Event reporting requirements
• Respond to misinformation posted by users on webpages owned, operated, or influenced by the company
• Control employee comments and responses

FDA’s compliance norms have been designed to ensure that all companies enforce QMS processes to manufacture higher quality products, that meet regulatory requirements.

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