Trade shows offer medical device companies direct access to decision-makers, but without FDA-compliant marketing, you risk more than just a bad impression.
Industry events like trade shows, healthcare expos, and medical conferences are some of the best marketing and sales channels for medical device companies. They offer medical device engineers, manufacturers, and sellers direct access to decision-makers, including healthcare providers like administrators and physicians, group purchasing organizations (GPOs), and medical device wholesalers. They provide the perfect forum to showcase innovations, build professional relationships, and strengthen brand credibility.
The FDA highly regulates the medical device industry, including regulating event marketing. Every trade show marketing asset, from brochures and banners to digital displays and product demonstrations, must align with the FDA's advertising and promotional regulations. If you do not meet regulatory standards, your company can face warning letters, fines, or even product recalls. Whether you're promoting a Class I device with general wellness claims or a Class III implantable requiring rigorous premarket approval (PMA), your marketing must remain truthful, non-misleading, and fully substantiated by clinical data [21 CFR 801, 21 CFR 812].
Marketing Guidance Documents Every Medical Device Company Needs
Staying compliant requires a deep understanding of FDA advertising policies, as well as close collaboration between your marketing, regulatory, and legal teams. Fortunately, the FDA releases detailed marketing guidance for medical device companies. Following the guidance in these documents to develop your event marketing will keep your marketing FDA-compliant:
FDA Code of Federal Regulations (CFR) Title 21: 21 CFR is the primary body of regulations governing medical devices in the United States. Specific sections related to marketing and advertising include:
21 CFR Part 801: Labeling requirements for medical devices, including how claims can be made about a device's intended use, performance, and safety.
21 CFR Part 820: Quality system regulations, which include requirements for device manufacturers on record-keeping and the marketing of devices in compliance with established safety standards.
FDA's Guidance Documents on Medical Device Promotion: Non-binding recommendations to help industry players understand how to stay compliant with FDA regulations when marketing medical devices. Examples include:
FDA's "Advertising and Promotion of Medical Devices" Guidance: Advice on how to create promotional materials that are truthful and not misleading, how to handle promotional activities, and what constitutes valid claims.
FDA's "Guidance on the Use of Social Media in the Promotion of Medical Devices": Specific advice on the unique challenges that come with marketing medical devices on social media platforms while maintaining compliance.
FDA Premarket Approval (PMA) and 510(k) Regulations: These are not marketing guidelines per se, but they do shape the promotional materials a manufacturer can use. Marketing materials for medical devices may need to reflect the claims that the FDA approved in the premarket submission.
Legal regulations change, so make a plan to stay up-to-date on any updates to FDA guidelines or regulations. A helpful tip for staying on top of changes is to subscribe to the FDA's email updates and routinely check the FDA's regulatory news page.
Five Regulatory Compliance Strategies For Trade Shows
The FDA actively monitors trade show marketing by reviewing booth displays, promotional materials, live demonstrations, and verbal statements made by sales representatives. FDA compliance officers attend industry events to monitor whether companies are making unauthorized claims, promoting investigational devices without proper disclaimers, or misrepresenting FDA clearance or approval. If compliance officers identify violations, the FDA may issue warning letters, request corrective action, or, in severe cases, pursue enforcement actions such as product seizures or fines.
Companies can stay compliant by ensuring all trade show marketing materials align strictly with FDA-authorized indications. All of your promotional materials, like booth signage, brochures, and digital displays, must align with the indications for use cleared or approved by the FDA. Per 21 CFR 801.6, any statements about clinical performance, benefits, or superiority must be backed by valid scientific evidence.
If you have an upcoming trade show, here are five strategies to keep your event marketing FDA-compliant:
1. Clearly Differentiate Between FDA-Cleared/Approved And Investigational Devices
If your company is showcasing both FDA-cleared/approved devices and investigational products, clearly separate them in your booth. Use signage to differentiate these categories. Under 21 CFR 812.7, the FDA strictly prohibits misleading claims about investigational products that suggest clinical efficacy, safety, or commercial availability before approval. Clearly label investigational devices with "For Investigational Use Only" and train your team to avoid making preemptive marketing statements that could misrepresent the device's regulatory status.
2. Use Appropriate Disclaimers On All Marketing Materials
Under 21 CFR 801.6, all trade show marketing materials should include necessary regulatory disclaimers, including:
A 510(k) pending or investigational device disclaimer if applicable.
A clarification that statements are based on cleared indications for use and not broader claims.
A risk disclosure if marketing materials mention clinical benefits, per FDA guidance on promotional labeling.
Failing to include required disclaimers can lead to FDA warning letters or enforcement actions.
3. Review All Marketing Materials With Regulatory And QA Teams
Create a formal marketing approval process where regulatory and QA teams provide documented sign-offs before materials go to print or digital distribution. Before every trade show, gather all marketing materials, including booth signage, brochures, product datasheets, digital presentations, and demo scripts for a comprehensive regulatory review. Your regulatory affairs and quality assurance (QA) teams should carefully examine every claim, image, and statement to verify that they align with FDA-cleared or approved indications and do not imply unapproved uses. They will also cross-check materials against 510(k) clearances, PMA approvals, or De Novo classifications to confirm accuracy.
4. Train Your Trade Show Staff On Regulatory Compliance
Your sales and marketing teams are often the first point of contact at trade shows, and any verbal statements they make are considered promotional claims. To stay compliant, conduct regulatory training sessions before the event so representatives understand what they can and cannot say about your devices. Trade show staff should refrain from making off-label claims, providing unapproved clinical performance data, or giving medical advice. Additionally, train your staff to keep discussions about competitive devices evidence-based to avoid misleading comparisons.
5. Implement a Documented Trade Show Compliance Monitoring Program
FDA enforcement actions against medical device companies often stem from unmonitored trade show activities. Establish a compliance monitoring program where designated regulatory and QA personnel periodically audit booth conversations, marketing materials, and any demonstrations for adherence to approved messaging. Document any compliance concerns and have an action plan in place to address them promptly. Post-event debriefs with marketing, sales, and regulatory teams help refine future trade show strategies while maintaining full compliance.
Following these tips will help you stay FDA-compliant even when showcasing pre-approved medical devices at trade shows.
When it comes to marketing medical devices, every claim, disclaimer, and word choice matters. The stakes are too high to leave marketing content to non-experts. Our team of expert medical writers understands how to balance FDA compliance with creativity. We create marketing materials that meet regulatory standards without diluting their commercial efficacy. Whether you need brochure copy that aligns with FDA-cleared uses, compliant booth signage, or precise claims that stand up to scrutiny, we've got you covered.
Contact Borrowed Pen now to discuss how we can support your medical device marketing.
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