Email, SMS and direct-message marketing for medical devices in the United States

Check the actual device status and advertising jurisdiction

Regulator guidance

Do not equate establishment registration, 510(k) clearance and premarket approval. Restricted-device advertising has specific information and misleading-advertising controls. Assess the exact device, authorised purpose and whether an advertised testing offer is also a clinical service.

Sources: General Controls for Medical Devices

Match the evidence to the precise advertised benefit

Regulator guidance

Applies when: The claim falls within FTC health-advertising oversight; FDA product-specific requirements also need review.

FTC guidance generally expects randomised controlled human clinical testing for health-benefit claims, with design and quality appropriate to the claim and the scientific field. Animal studies or consumer anecdotes alone do not establish human benefits.

Assess the actual formulation, dose, population and outcome. An ingredient study or a clinically tested claim must not imply a proven finished-product effect that the evidence does not support.

Sources: FTC Health Products Compliance Guidance · FTC Health Products Compliance Guidance, substantiation and amount/type of evidence

Review implied claims as well as literal wording

Regulator guidance

FTC guidance assesses the overall impression of health advertising. Hold appropriate scientific evidence before publication; an honest testimonial does not substitute for evidence of the advertised result. Treat imagery and omitted qualifications as part of that assessment.

Sources: FTC Health Products Compliance Guidance

Commercial email follows CAN-SPAM; SMS needs its own review

Regulator guidance

CAN-SPAM requires accurate sender and subject information, advertising identification as applicable, a postal address and a clear opt-out. Honour opt-outs within ten business days. It is not a general prior-consent requirement for all commercial email and does not determine the separate TCPA or state rules for marketing texts.

Sources: CAN-SPAM Act: A Compliance Guide for Business

Analyse marketing calls and texts separately from email

Regulator guidance

For calls and texts covered by the TCPA, identify the calling technology, message purpose, recipient number and any exemption. Covered telemarketing generally requires prior express written consent; CAN-SPAM compliance does not supply it. Preserve consent evidence and an effective revocation process. The 2024 order is not a complete statement of later implementation dates: check subsequent FCC orders, litigation and state rules before approving a live SMS programme.

Sources: TCPA consent and revocation order

Washington health data may be regulated outside HIPAA

Regulator guidance

Applies when: Processing within the scope of Washington’s My Health My Data Act.

Where Washington’s My Health My Data Act applies, collection generally needs purpose-specific consent unless necessary for a requested product or service; sharing requires a distinct consent unless the necessary-service exception applies. Review applicability and exemptions by data and activity, rather than assuming HIPAA status clears advertising tracking. Regulated entities must prominently link a separate consumer health data privacy policy from the homepage.

Sources: Washington consumer-health-data collection and sharing; My Health My Data Act — scope and FAQ

Separate promotional and service messages

Editorial recommendation

Review the rules for the actual delivery method: email, SMS and private social messages are not interchangeable. Keep the relevant permission record, accurate sender details and a working suppression process.

Medical Devices & Medtech: prepare the review

Editorial recommendation

Identify the device, intended purpose, risk class and intended users. Check local market status and any advertising review or public-promotion restriction. Use performance evidence for the advertised model and purpose; distinguish registration from approval.

Keep a traceable campaign decision

Editorial recommendation

Keep one review record linking the offer, local market status, claim evidence, exact creative, media settings and any regulatory or professional clearance. Record who checked each condition. Reopen the review when the offer, claim, source rule or execution changes.