Medical Product Communications That Are Consistent With FDA-Required Labeling
This guidance provides information for firms about how FDA evaluates medical product communications that present information not contained in the FDA-required labeling but may be consistent with it. It applies to drugs and devices for humans (including biologics) and animal drugs. The guidance focuses on communications about approved/cleared uses of products while ensuring they remain truthful and non-misleading.
Recommended Actions
- Establish a review process involving qualified medical/scientific, legal and regulatory personnel
- Develop a checklist to verify communications are:
- Consistent with FDA-required labeling
- Supported by appropriate scientific evidence
- Include required contextual information and disclosures
- Implement procedures to ensure:
- Accurate representation of study results
- Clear disclosure of material limitations
- Inclusion of relevant FDA-required labeling information
- Create documentation templates that capture:
- Evidence supporting communications
- Rationale for consistency with FDA-required labeling
- Risk assessment regarding potential for harm
- Maintain records of reviews and approvals of communications
- Train relevant personnel on requirements and internal procedures
- Regularly monitor and update communications based on new safety information
Key Considerations
Clinical testing
- Clinical study results must be accurately represented and contextualized
- Material limitations of study design and methodology must be disclosed
- Unfavorable or inconsistent findings should be disclosed
- Data from FDA-required labeling should be included for context when relevant
Labelling
- Communications must be consistent with FDA-required labeling regarding:
- Indication
- Patient population
- Limitations and directions for use
- Dosing/use regimen and administration
- Information must be truthful and non-misleading
- Material limitations must be clearly and prominently disclosed
Safety
- Communications should not increase potential for harm relative to FDA-required labeling
- Safety information from FDA-required labeling should be included when relevant
- Unfavorable safety findings should be disclosed
Other considerations
- Evidence must be scientifically appropriate and statistically sound
- Claims must be supported by appropriate data
- Material aspects of study design and methodology must be disclosed
- Qualified medical/scientific, legal and regulatory personnel should review communications
Relevant Guidances
- Health Care Economic Information Communications to Payors for Medical Devices
- General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms
- 21 CFR 201.56: Requirements on content and format of labeling for human prescription drug and biological products
- 21 CFR 202.1: Prescription drug advertisements
- 21 CFR 807.81: When a premarket notification submission is required
Original guidance
- Medical Product Communications That Are Consistent With FDA-Required Labeling
- HTML / PDF
- Issue date: 2018-06-13
- Last changed date: 2024-11-12
- Status: FINAL
- Official FDA topics: Medical Devices, Drugs, Animal & Veterinary, Biologics, Administrative / Procedural
- ReguVirta summary file ID: 9bbdb45917b13a4eaf93867608efd6aa
This post is licensed under CC BY 4.0 by the author.