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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.

  1. Develop a compliant template for investigational device availability notices
  2. Establish an IRB review process for all recruitment materials
  3. Create guidelines for appropriate investigator solicitation methods
  4. Implement a review process for all communications about investigational devices
  5. Train relevant staff on proper communication about investigational devices
  6. Maintain documentation of all notices and recruitment materials
  7. Create a checklist for required and prohibited content in communications
  8. Establish a process to verify investigator qualifications
  9. Develop standard operating procedures for recruitment activities
  10. 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

  • 21 CFR Part 812: Investigational Device Exemptions
  • 21 CFR Part 50: Protection of Human Subjects
  • 21 CFR Part 56: Institutional Review Boards

Original guidance

  • Promotion and Recruitment for Investigational Medical Devices
  • HTML / PDF
  • Issue date: 1999-03-19
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket
  • ReguVirta summary file ID: ccd4fbb47d6b653a6a2ce6e0843fc26b
This post is licensed under CC BY 4.0 by the author.