Maintaining Independence of Industry-Supported Scientific and Educational Activities
This guidance addresses the distinction between independent scientific/educational activities supported by medical product companies and promotional activities. It provides direction on how companies can support educational activities while maintaining their independence from promotional influence.
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, educate healthcare professionals, and support research. These activities must maintain independence and scientific integrity while providing valuable educational content.
How can medical device companies ensure compliance when sponsoring educational events?
Companies must maintain clear separation between promotional and educational content, ensure scientific objectivity, provide balanced information, disclose financial relationships, and avoid influencing educational content. Independent oversight and transparent funding arrangements are essential for compliance.
What disclosure requirements apply to industry-sponsored medical education programs?
All financial relationships between sponsors and educational providers must be disclosed to participants. This includes funding sources, speaker fees, research grants, and any potential conflicts of interest that could influence the educational content or presentation.
Are there restrictions on promotional activities during industry-supported educational events?
Yes, promotional materials and sales activities are typically prohibited during educational sessions. Companies must clearly separate educational content from promotional activities, ensuring the educational program maintains scientific objectivity and independence from commercial interests.
How should digital health companies approach sponsoring virtual educational programs?
Digital health companies must apply the same compliance principles to virtual events as in-person programs. This includes maintaining educational independence, proper disclosures, avoiding promotional content integration, and ensuring transparent separation between educational and commercial activities.
What documentation is required for industry-supported scientific activities in medical devices?
Companies should maintain records of funding agreements, educational content review processes, disclosure statements, participant communications, and evidence of independence measures. Documentation should demonstrate compliance with regulatory guidelines and institutional policies.
What You Need to Do 👇
Recommended Actions
- Establish clear written policies for supporting educational activities
- Implement procedures to ensure separation between promotional and educational activities
- Create documentation templates for financial support agreements
- Develop a review process to ensure compliance with independence requirements
- Train relevant staff on the distinction between promotional and educational activities
- Maintain records of all supported educational activities and related agreements
- Regularly audit supported activities to ensure compliance with independence requirements
- Establish clear disclosure procedures for company support
- Create guidelines for appropriate interaction with educational providers
- Implement monitoring system for potential conflicts of interest
Key Considerations
Other considerations
- Provider must maintain full control over the content, faculty, educational methods, and materials
- Company’s role must be limited to providing financial support
- No direct influence on program content or speaker selection
- Clear disclosure of company support must be made
- Physical separation between promotional exhibits and educational activities
- No requirement for attendees to visit promotional exhibits
- Educational provider must be independent from the supporting company
- Supporting company cannot suggest content or speakers
- Materials distributed should be free from commercial bias
Relevant Guidances 🔗
Related references and norms 📂
No specific norms or standards referenced in this guidance.
Original guidance
- Maintaining Independence of Industry-Supported Scientific and Educational Activities
- HTML / PDF
- Issue date: 1997-11-01
- Last changed date: 2020-04-24
- Status: FINAL
- Official FDA topics: Medical Devices, Drugs, Animal & Veterinary, Biologics, Administrative / Procedural
- ReguVirta ID: 0034a8dd9ff24ed280e044eefed4d5cc