Regulated Industries
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
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
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.
Find out where your medical device sales website stands
6,919+ checks. Hand-reviewed. Free. Takes 30 seconds to submit.
Get Your Free Checkup →Learn more about medical device sales websites
Does Your Industry Have Website Requirements? What NH Businesses Need to Know
Law firms, financial advisors, healthcare, and real estate all have industry-specific website rules. Learn what is revie...
6 min readWhat Is a Website Conformance Review and Why Does Your Business Need One?
A website conformance review checks your site against industry-specific regulations and standards. Learn what it covers,...