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Industry-Supported Scientific and Educational Activities: Maintaining Independence from Promotional Influence

This guidance addresses the distinction between industry-supported scientific and educational activities and promotional activities. It provides direction on how companies can support educational activities while maintaining their independence from promotional influence.

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By ReguVirta
2 min read

What You Need to Know? 👇

What are industry-supported scientific and educational activities in medical devices?

Industry-supported scientific and educational activities are programs funded by medical device companies to advance scientific knowledge, provide medical education, and support research initiatives while maintaining independence from promotional activities.

How do FDA regulations apply to industry-sponsored medical education events?

FDA guidance requires clear separation between promotional activities and genuine educational content. Educational events must be independent, scientifically balanced, and not primarily serve commercial promotional purposes for specific medical devices.

What compliance requirements exist for medical device companies sponsoring educational activities?

Companies must ensure educational independence, avoid promotional bias, maintain transparent funding disclosure, provide balanced scientific content, and separate educational activities from sales and marketing functions.

Can medical device manufacturers sponsor continuing medical education (CME) programs?

Yes, manufacturers can sponsor CME programs through unrestricted educational grants to accredited providers, ensuring content independence and compliance with accreditation standards that prevent commercial bias in educational materials.

What documentation is required for industry-supported scientific activities?

Required documentation includes funding agreements, educational content reviews, independence certifications, conflict of interest disclosures, and records demonstrating separation between educational and promotional activities.

How should conflicts of interest be managed in industry-sponsored medical education?

Conflicts must be transparently disclosed, educational content must remain independent from sponsor influence, and clear policies should separate commercial interests from educational objectives and scientific integrity.

What You Need to Do 👇

  1. Develop clear policies for supporting educational activities that ensure independence from promotional influence
  2. Implement procedures for reviewing and approving educational support requests
  3. Create documentation systems to track educational grants and support
  4. Establish criteria for evaluating educational providers and programs
  5. Train relevant staff on the distinction between promotional and educational activities
  6. Maintain clear separation between marketing/sales departments and educational grant decision-making
  7. Regularly audit educational support activities to ensure compliance with guidance
  8. Document all funding disclosures and agreements with educational providers
  9. Review promotional materials to ensure they don’t inappropriately reference supported educational activities

Key Considerations

Other considerations

  • Industry supporters should have no control over content, speakers, or materials of educational activities
  • There should be full disclosure of industry funding
  • The educational provider should maintain full independence in developing program content
  • Multiple company support is encouraged to minimize individual company influence
  • Industry supporters should not be involved in promoting the educational activity directly to attendees
  • Educational materials should be balanced and scientifically rigorous
  • Venue and circumstances of the educational activity should be appropriate for scientific/educational communication

Relevant Guidances 🔗

Related references and norms 📂

No specific norms or ISO standards are referenced in this guidance.

Original guidance

  • Industry-Supported Scientific and Educational Activities: Maintaining Independence from Promotional Influence
  • HTML / PDF
  • Issue date: 1997-12-03
  • Last changed date: 2019-04-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Advertising, Drugs, Animal & Veterinary, Biologics, Administrative / Procedural
  • ReguVirta ID: 8a1523921f5f14751df1a592b2288ce1
FDA guidance, Final
Medical Devices Advertising Drugs Animal & Veterinary Biologics Administrative / Procedural
This post is licensed under CC BY 4.0 by the author.