Promotion and Recruitment for Investigational Medical Devices
This guidance clarifies regulations regarding the promotion of investigational medical devices and provides guidelines for preparing notices of availability and recruiting study subjects. It specifically addresses how to communicate about investigational devices while avoiding promotional activities prohibited under 21 CFR Part 812.7.
Recommended Actions
- Develop a compliant template for investigational device availability notices
- Establish an IRB review process for all recruitment materials
- Create guidelines for appropriate investigator solicitation methods
- Implement a review process for all communications about investigational devices
- Train relevant staff on proper communication about investigational devices
- Maintain documentation of all notices and recruitment materials
- Create a checklist for required and prohibited content in communications
- Establish a process to verify investigator qualifications
- Develop standard operating procedures for recruitment activities
- Set up monitoring system to ensure ongoing compliance with promotional restrictions
Key Considerations
Clinical testing
- Clinical investigators must be qualified experts with scientific training and experience
- Number of investigators should be limited to those necessary to evaluate safety and effectiveness
- Investigators must await IRB and FDA approval before starting subject participation
Labelling
- Must include prominent “Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE” statement
- No claims of reliability, durability, dependability, safety, or effectiveness
- No comparative descriptions with other devices allowed
- Reasonably sized drawings or photographs of the device are permitted
Other considerations
- Notices should be limited to medical/scientific publications or conferences
- Direct mailing only for soliciting qualified experts (no mass mailing)
- No volume discounts allowed
- Recruitment advertisements require IRB review
- Advertisements should not:
- Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Design Considerations for Medical Device Pivotal Clinical Studies
Related references and norms
- 21 CFR Part 812: Investigational Device Exemptions
- 21 CFR Part 50: Protection of Human Subjects
- 21 CFR Part 56: Institutional Review Boards
Original guidance
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