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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.

  1. 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
  2. Implement quality control procedures for:
    • Label inspection upon receipt
    • Storage and handling of labels
    • Application of labels to devices
    • Prevention of label mix-ups
  3. 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
  4. Maintain records of:
    • Label specifications and artwork
    • Label approvals and changes
    • Label inspection results
    • Label application procedures
  5. 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

  • MIL-STD-129H: Military Standard for Marking for Shipment and Storage

Original guidance

  • Labeling Requirements and Recommendations for Medical Devices
  • HTML / PDF
  • Issue date: 1989-09-01
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 7d1e1df5407a80a0a1503a3b4f1dcf15
This post is licensed under CC BY 4.0 by the author.