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.
What You Need to Know? 👇
What are the key requirements for advertising investigational medical devices to recruit clinical investigators?
Notices must be published only in medical/scientific publications, clearly state the purpose is to obtain investigators (not general availability), limit information to device use, sponsor details, and application process, and include the required “INVESTIGATIONAL DEVICE” caution statement prominently.
Can sponsors offer volume discounts for investigational medical devices during clinical trials?
No, sponsors should not offer volume discounts for investigational devices. FDA considers such discounts as promotion of an investigational device, which violates regulations prohibiting the promotion or test marketing of investigational medical devices under 21 CFR Part 812.
What claims are prohibited when advertising investigational medical devices?
No claims stating or implying the device is reliable, durable, safe, or effective for investigational purposes are allowed. Comparative descriptions with other devices are prohibited, though reasonably sized drawings or photographs of the device may be included.
What IRB oversight is required for subject recruitment advertisements in device studies?
IRBs must review recruitment advertisements as part of informed consent and subject selection. They must ensure information isn’t misleading, procedures aren’t coercive, and advertisements don’t promise certainty of favorable outcomes beyond what’s in the consent document.
What terminology should be avoided when recruiting subjects for investigational device studies?
Avoid “new treatment” without explaining the investigational nature, “free medical treatment” when meaning no charge for participation, and emphasizing payment amounts. Don’t claim the device is safe, effective, or superior to existing devices.
What essential information should be included in subject recruitment advertisements for device studies?
Include investigator/facility name and address, condition under study, eligibility criteria summary, participation benefits, time commitment required, research location, and contact information. Keep information limited to what prospective subjects need to determine eligibility and interest.
What You Need to Do 👇
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:
- Be coercive
- Imply certainty of favorable outcomes
- Use term “new treatment” without explaining investigational status
- Promise “free medical treatment”
- Emphasize payment amounts
Relevant Guidances đź”—
- 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 đź“‚
- 21 CFR Part 812: Investigational Device Exemptions
- 21 CFR Part 50: Protection of Human Subjects
- 21 CFR Part 56: Institutional Review Boards