Labeling and Advertising Compliance

Comprehensive Labeling and Advertising Compliance for Devices

We assist medical device manufacturers in ensuring their labeling and advertising materials comply with FDA and international regulatory requirements. Our services promote compliance, safety, and regulatory adherence, safeguarding your product’s approval and market success.

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ADBC CRO’s Labeling & Advertising Compliance service helps medical device companies meet all FDA requirements for product labels, instructions, and marketing materials. We provide expert guidance on what must (and must not) be included on device labels per 21 CFR 801, and we review your advertising/promotional content to ensure it aligns with approved uses. By proactively addressing labeling and advertising compliance, you avoid the risk of FDA “misbranding” violations, ensure truthful and balanced promotion of your device, and protect your reputation in the market.

Our Services Include

FDA Labeling Basics for Medical Devices Introduction to FDA’s core labeling rules. Defines what counts as a “label” vs. “labeling” under the FD&C Act and 21 CFR 801, and explains why compliant labeling (beyond just the device sticker, including manuals and marketing materials) is crucial to avoid a device being deemed misbranded.

Essential Elements of Compliant Device Labeling Outlines the key information every medical device label must contain to meet FDA requirements. Covers elements like manufacturer’s name and address, device name and intended use, quantity of contents, necessary warnings, and UDI (Unique Device Identifier) placement – all the basics that must be present for a label to be compliant.

Adequate Directions, Warnings & Precautions – Labeling Requirements Explains FDA requirements for providing “adequate directions for use” in device labeling (or the “Rx Only” exemption for prescription devices) and including any necessary warnings/precautions. Highlights how missing directions or safety warnings can lead to a device being misbranded, and what manufacturers should do to ensure their instructions and caution statements meet 21 CFR 801 subpart requirements.

FDA Regulation of Medical Device Advertising & Promotion An overview of how advertising and promotional activities for devices are regulated. Discusses the FDA’s oversight (versus FTC’s role) on device ads, the need for truthfulness and no misleading claims, and special rules for restricted devices (e.g., prescription device ads must include certain information). Helps companies understand what they can and cannot say when marketing their device.

Misbranding & Off-Label Promotion – Compliance Risks Focuses on the risk of promoting a device for unapproved uses or making claims inconsistent with its labeling. Describes how off-label promotion can lead to FDA deeming those materials as misbranding. Includes examples of what constitutes misbranding in advertising and the potential enforcement actions (warning letters, fines) that can result – underscoring why marketing must stay on-label.

Unique Device Identifier (UDI) Requirements & Label Integration Explains FDA’s UDI system and what manufacturers must do to comply. Covers how to obtain a UDI code for your device, proper placement of the UDI on labels/packaging, and submission of device data to the FDA’s GUDID database. Emphasizes how UDIs improve traceability and are a required element for most device labels in the US.

Digital & Social Media Compliance for Medical Device Marketing Guidance for promoting devices on online platforms while staying compliant. Addresses considerations like ensuring social media posts or website content about the device are truthful and balanced, include necessary disclosures (e.g., risks for a product claim post), monitoring user-generated content for off-label discussions, and following FDA’s specific guidelines for internet/social media promotion.

Common Medical Device Labeling Violations and How to Avoid Them A rundown of frequent mistakes that lead to FDA labeling citations. For example, incorrect or missing information on labels, false or overstated claims, not updating labels after device changes, or inconsistent labeling across materials. Provides tips on avoiding these pitfalls, such as regular label reviews, compliance checklists, and training for marketing teams.

Case Studies – FDA Enforcement Actions on Device Labeling & Advertising Real examples of companies that faced FDA enforcement due to labeling or advertising issues. Describes cases like warning letters for off-label promotion or product seizures due to misbranding, detailing what went wrong and the consequences. These case studies illustrate the importance of compliance and lessons that other manufacturers can learn to prevent similar issues.

Best Practices for Global-to-US Medical Device Labeling Alignment Advice for companies that sell devices internationally on how to adapt their labeling to U.S. FDA standards. Discusses differences such as language requirements, units of measurement, use of symbols, the need to list a U.S. manufacturer or importer, and other adjustments when transitioning EU MDR-compliant labels or other international labeling to the U.S. market. Emphasizes aligning global marketing claims with what’s cleared/approved by FDA.

Contact us for labeling and advertising compliance services!

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