Compliance Communication Guidelines for Clinics

These guidelines provide educational direction for licensed medical professionals and clinics regarding compliant communication of tissue-based product categories discussed within the HCT/P framework.

The purpose is to promote regulatory alignment, reduce enforcement risk, and support consistent messaging under 21 CFR Part 1271.

Clinic Communication Compliance Framework outlining regulatory alignment, prohibited claims, marketing oversight, and clinical autonomy boundaries under 21 CFR Part 1271
Educational reference only. Communication compliance framework under 21 CFR Part 1271.

Regulatory Communication Principles

Communications should remain consistent with the product’s regulatory classification and homologous use limitations.

Establishment registration under 21 CFR Part 1271 does not constitute FDA approval or endorsement.

Prohibited Representations

Clinics and staff should avoid the following:

  • Statements that a product is FDA-approved to diagnose, treat, cure, or prevent disease
  • Guarantees of specific patient outcomes
  • Claims of permanent results
  • Non-homologous use positioning inconsistent with regulatory classification
  • Comparisons implying superiority over approved drugs or devices

Marketing materials, website content, and social media posts should reflect these limitations.

Appropriate Communication Framework

Language may reference structural support, tissue supplementation, and alignment with homologous use where applicable.

Educational discussions should avoid therapeutic positioning or disease-specific claims.

Staff Training Considerations

Clinical and administrative staff should be trained to:

  • Use compliant terminology
  • Avoid outcome guarantees
  • Direct regulatory questions to licensed providers
  • Refrain from making medical determinations

Documentation of internal communication standards may support regulatory defensibility.

Website & Digital Marketing Oversight

Online materials should be periodically reviewed to ensure consistency with regulatory classification and homologous use limitations.

Testimonials should not imply disease treatment or guaranteed results.

Independent Clinical Judgment

Licensed medical professionals retain full responsibility for independent clinical evaluation and patient communication.

No content herein should be interpreted as legal advice or regulatory determination.

Educational reference only. Certain products referenced may be regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR 1271. These materials have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease.