Labeling Requirements and Recommendations for Medical Devices
This guidance explains label and labeling regulations and requirements for medical devices under the Food, Drug, and Cosmetic (FD&C) Act. It covers topics such as advertising matter as labeling, false and misleading labeling, prominence of labeling information, container labeling requirements, adequate directions for use, prescription device requirements, and special labeling for particular devices and uses.
What You Need to Know? 👇
What are the key differences between “label” and “labeling” for medical devices?
“Label” refers to written, printed, or graphic matter on the immediate container of a device. “Labeling” is broader, encompassing all labels plus other written materials accompanying the device, including instruction manuals, brochures, and promotional materials that travel with the product.
What constitutes misbranding under FDA regulations for medical devices?
A device is misbranded if its labeling is false or misleading, lacks adequate directions for use, fails to display required information prominently, doesn’t contain proper manufacturer identification, or creates an impression of FDA approval through registration numbers.
What are the specific labeling requirements for prescription medical devices?
Prescription devices must bear the statement “Caution: Federal law restricts this device to sale by or on the order of a [licensed practitioner],” include information for safe use, and have all labeling dated with issuance or latest revision date.
How do Good Manufacturing Practice (GMP) requirements affect device labeling?
GMP requires labels to remain legible during normal use, proper storage and handling of labeling materials, area inspection before labeling operations, proofreading of labels, and formal change control systems for any labeling modifications to ensure quality and prevent mixups.
What additional labeling is required for critical devices under GMP?
Critical devices must have a control number for traceability on labeling reaching the end user, require proofreader signatures and dates in device history records, and restrict access to labeling materials to authorized personnel only.
What are the main labeling requirements for radiation-emitting medical devices?
Radiation-emitting devices must display manufacturer name and address, month/year of manufacture, and specific warnings based on radiation type. Laser products require class-specific warning logotypes, aperture labels, and detailed user information including safety precautions and maintenance schedules.
What You Need to Do 👇
Recommended Actions
- Establish a formal labeling development and approval process that includes:
- Review by product development, service, marketing, and quality assurance
- Validation of instructions through user testing
- Documentation of approvals
- Implement quality control procedures for:
- Label inspection upon receipt
- Storage and handling of labels
- Application of labels to devices
- Prevention of label mix-ups
- Create labeling that:
- Is written at appropriate reading level for intended users
- Uses consistent terminology throughout
- Includes clear warnings and cautions
- Provides specific storage and handling instructions
- Maintain records of:
- Label specifications and artwork
- Label approvals and changes
- Label inspection results
- Label application procedures
- Review labeling periodically to ensure:
- Continued compliance with regulations
- Accuracy of content
- Clarity for users
- Effectiveness in preventing misuse
Key Considerations
Human Factors
- Consider WHO will be using the device and HOW it is to be used when developing labeling
- Determine reading level of intended users for home-use devices
- Have someone unfamiliar with the product test the labeling by operating according to instructions
- Solicit input from actual users on clarity and reading level
Labeling
- Must include name and place of business of manufacturer, packer, or distributor
- Must include adequate directions for use including warnings against dangerous uses
- Labels must remain legible during customary conditions of use
- Avoid ambiguous geometric terms (top, side, end, etc.)
- Use consistent terminology throughout all labeling
- Keep sentences short and specific
- Introduce and define new terms before use
- Accentuate key terms and warnings through formatting
- Include control numbers for traceability on critical devices
Safety
- Must include warnings against uses dangerous to health
- Must include information necessary for protection of users
- Must include caution statements for hazardous situations
- Must specify storage conditions and expiration dates where applicable
Other considerations
- Labeling must not be false or misleading
- Cannot imply FDA approval through registration numbers
- Must meet any additional requirements for specific device types
- Must have formal change control system for labeling changes
- Must have quality control procedures for labeling operations
Relevant Guidances đź”—
- Device Labeling Requirements and Content for Premarket Approval Applications
- Sharing Patient-Specific Information from Medical Devices with Patients
- Unique Device Identifier (UDI) Form and Content Requirements
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
Related references and norms đź“‚
- MIL-STD-129H: Military Standard for Marking for Shipment and Storage