Device Labeling Requirements and Content for Premarket Approval Applications
This guidance provides formal direction for FDA reviewers and industry regarding device labeling requirements, particularly for premarket approval applications (PMAs). It aims to ensure adequacy and consistency in device labeling information by providing definitions and explanations of key labeling terms and requirements.
Recommended Actions
- Review and ensure all required labeling sections are included (Indications, Contraindications, Warnings, Precautions, Adverse Reactions)
- Verify labeling content meets readability requirements and uses appropriate terminology
- Ensure prescription device labeling includes all required statements and restrictions
- Review and remove any inappropriate disclaimers or suggestions of FDA approval
- Develop patient information labeling when appropriate based on risk factors
- Verify all safety information is properly organized and presented
- Ensure labeling includes appropriate information for special patient populations
- Review and confirm accuracy of all manufacturer information and content statements
- Verify compliance with restricted device requirements if applicable
- Document justification for any deviations from standard labeling requirements
Key Considerations
Human Factors
- Patient information labeling should not exceed seventh grade reading comprehension level
- Technical terms should be kept to minimum and defined when necessary
Labeling
- Must include manufacturer name, place of business, and accurate quantity statement
- Required information must be prominently placed and easily readable
- Must include adequate directions for use and warnings
- False or misleading labeling is prohibited
- For prescription devices, must include “Caution: Federal law restricts…” statement
- Must include indications for use, contraindications, warnings, precautions, and adverse reactions
- Should include information about special patient populations and limitations
Safety
- Must describe serious adverse reactions and potential safety hazards
- Include appropriate warnings when reasonable evidence of serious hazards exists
- List adverse reactions in order of clinical significance
- Include precautionary information about protective wear and monitoring requirements
Other considerations
- Disclaimers regarding safety and effectiveness should be avoided
- Cannot include representations suggesting official FDA approval
- For restricted devices, additional labeling requirements apply regarding sale and distribution restrictions
Relevant Guidances
- Labeling Requirements and Recommendations for Medical Devices
- Writing Medical Device Patient Labeling: Content and Design Considerations
Original guidance
- Device Labeling Requirements and Content for Premarket Approval Applications
- HTML
- Issue date: 1991-03-07
- Last changed date: 2020-03-17
- Status: FINAL
- Official FDA topics: Medical Devices, Labeling, Premarket
- ReguVirta summary file ID: a3d74ec2709dbdbbd7ecaffcef61f52c
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