Website & Marketing Compliance

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TL;DR

All public-facing content for a medical device including your website, social media, and marketing materials is considered advertising by regulators like the FDA. Every claim you make online must perfectly match the claims proven in your official regulatory submission. Any misalignment creates serious compliance risks, potentially leading to warning letters, fines, and even criminal charges. Be truthful, not aspirational.

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Introduction

Regulators view their primary mission as patient protection. To them, your company’s website isn’t just a marketing tool; it’s a collection of claims that must be rigorously fact-checked against your official device submission. They scrutinize every piece of content associated with your device to ensure you are not making unproven, misleading, or off-label claims. This guide provides a high-level overview of what you can and cannot say, helping you navigate the digital tightrope and ensure your online presence supports, rather than jeopardizes, your regulatory success.

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The Golden Rule: Be Truthful, Not Aspirational

Your website is not the place for your “vision” of what your product might do one day. It’s for what it is proven to do right now. All your content must be:

• Truthful ✅: Based only on verified data and evidence from your regulatory submission.
• Balanced ⚖️: Always present both the benefits and the risks, including contraindications and limitations.
• Not Misleading 🚫: Avoid any language that could cause patients or doctors to believe your device does more than it is cleared for.

Ask yourself this critical question for every piece of content: “Could a patient or doctor misunderstand this and believe our device does more than it’s cleared for?” If the answer is “maybe,” you must revise the wording immediately.

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What You CAN Say

What you’re allowed to say depends on your device’s regulatory status. Let’s look at the two cases:

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If Your Device is NOT YET Cleared/Approved

Focus on the company and the technology, not the product’s unproven medical benefits.

• Company & Technology Focus:
  • Discuss the problem you’re solving (e.g., disease state education).
  • Highlight your team’s expertise and credentials.
  • Provide general descriptions of the science or technology.
  • Share company news like mission, history, and funding.
• Required Disclaimers: You must display a clear and prominent disclaimer.
  • Example 1: “This product is investigational and not available for sale in [Country/Region].”
  • Example 2: “This technology is in development. Claims have not been evaluated by the FDA.”

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If Your Device IS Cleared/Approved

Stick strictly to the scope of your approval.

• Approved Content:
  • Quote your Indications for Use (IFU) directly from your clearance document.
  • Explain the mechanism of action as proven in your submission.
  • Present clinical data that directly supports your cleared IFU.
  • Provide balanced risk and benefit information.
• Testimonials: Patient and physician testimonials are allowed, but they must be:
  • Truthful and representative of typical experiences.
  • Reflective of your cleared IFU only.
  • Accompanied by appropriate disclaimers.

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What You CANNOT Say 🛑

Certain words and promotional tactics are major red flags for regulators. Avoid them at all costs.

• “Magic Words” to Avoid: Unproven superlatives will attract immediate scrutiny. Don’t use words like “Best,” “Most Effective,” “Revolutionary,” “Guaranteed,” or “First-ever” unless you have incredibly strong, direct comparative clinical data to prove it.
• Pre-Approval Promotion: Never promote an investigational device as safe or effective before it’s officially cleared. This is a serious violation that can delay or prevent approval.
• Off-Label Hints: Never discuss, hint at, or imply how your device could be used for conditions outside of its specific clearance. This is “off-label promotion” and a major compliance violation.
• Downplaying Risks: Never use terms like “completely safe” or imply there are no side effects. You must always present balanced risk information as required by your labeling.
• “Cure” Claims: This word is a regulatory landmine. Your device treats, diagnoses, or manages conditions—it does not “cure” them. Using this word can trigger immediate enforcement action.

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Simple Phrasing to Keep You Safe

Here’s how to transform risky language into compliant messaging that still communicates value.

Instead of This	Try This	Why It’s Better
”Our revolutionary device treats all forms of chronic back pain."	"Our device is indicated for the temporary relief of chronic, intractable back pain.”	Aligns with a specific, cleared indication and avoids superlative language.
”The safest and most effective solution on the market."	"In a clinical study, X% of patients experienced [cleared outcome] compared to Y% with a sham device.”	Replaces a subjective claim with objective, verifiable clinical data.
”A guaranteed way to monitor your heart health."	"Our device is intended to record, store, and transfer single-channel ECG rhythms.”	States the device’s specific function rather than promising a broad health outcome.
”The future of surgery is here.” (for an investigational device)	“This device is limited by Federal law to investigational use.”	Provides the legally required disclaimer for unapproved devices.

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Cautionary Tales: Real-World Examples

• Off-Label Promotion (Vascular Solutions, Inc.): The company promoted its Vari-Lase device for treating perforator veins, a use for which it was not cleared. Consequence: The CEO faced criminal charges, and the company suffered significant legal costs and reputational damage.
• Premature Marketing (WHOOP, Inc.): The company marketed its Blood Pressure Insights feature with claims like “medical-grade health & performance insights” before receiving FDA authorization. Consequence: The FDA issued a warning letter, forcing the company to remove misleading language from its website.
• Unsubstantiated Claims (Vevazz LLC): Their website claimed their LED-light therapy devices could be used for fat loss, skin tightening, and scar treatment, which were uses not supported by their clearance. Consequence: An FDA Warning Letter forced them to alter their claims and damaged their credibility.

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Conclusion: Your Action Plan

Integrate these simple steps into your workflow to build a culture of compliance.

1. Assign a “Compliance Captain”: Designate one person (e.g., from regulatory affairs or legal) as the final checkpoint for all public content. No exceptions.
2. Make Your IFU Your North Star ⭐: Print your official Indications for Use (IFU) statement and post it where your marketing team can see it. If a claim isn’t supported by that exact statement, it doesn’t go online.
3. Create a “Banned Words” List: Start a list of words to avoid. Include: Cure, Perfect, Guaranteed, Safest, Revolutionary, Best, and Most Effective.
4. Audit Monthly: Dedicate 30 minutes each month to reviewing your website, social media, and ads from a regulator’s perspective. Document your findings and corrections in a compliance log.

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FAQ