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FDA considers your website promotional labeling. Every product claim is subject to enforcement.

Medical device manufacturers, distributors, and resellers must display FDA clearance status, balance risk and benefit claims, and avoid off-label promotion on their websites.

What regulators look for on medical device sales websites

Missing FDA 510(k) clearance or PMA approval numbers

Promotional claims exceeding FDA-cleared intended use

No risk disclosure alongside product benefit claims

Missing FDA establishment registration (FEI number)

Who regulates medical device sales websites

FDA
FTC
CMS
State Medical Device Boards

We review your website against requirements from each of these regulatory bodies. This is an informational review, not legal advice. Consult with your attorney for guidance specific to your situation.

What we check

14 medical device sales-specific checksTailored to medical device sales regulatory requirements
6,919+ total checks in every auditSpeed, SEO, accessibility, security, and mobile
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Common questions about medical device sales websites

Does my medical device website count as FDA-regulated labeling?

Yes. Under 21 CFR 801.4, FDA evaluates all surrounding circumstances including website content to determine intended use. Your product pages, case studies, testimonials, and blog posts are all considered labeling or promotional material subject to FDA enforcement.

What FDA clearance information should I display on product pages?

Each product page should show the FDA clearance type (510(k), De Novo, or PMA), the clearance/approval number, device classification (Class I/II/III), and the cleared intended use. Omitting this information raises red flags for misbranding under FFDCA Section 502.

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