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Premarket Notification Requirements for Urine Drainage Bags and Accessories

This guidance outlines the requirements for premarket notifications (510(k)) for urine drainage bags and accessories, covering both Class I (external catheter use) and Class II (indwelling catheter use) devices. It provides specific information needed to determine substantial equivalence to existing devices.

  1. Prepare detailed device description with labeled diagrams and specifications
  2. Conduct comprehensive bench testing for functional performance
  3. Perform required biocompatibility testing based on device classification
  4. Develop complete labeling package including IFU and warnings
  5. Validate sterilization processes if applicable
  6. Document any modifications from predicate devices with supporting data
  7. Prepare clinical data if making infection reduction claims
  8. Create testing protocols for any absorbent materials or adhesives
  9. Ensure compliance with all applicable regulations and standards
  10. Maintain documentation of all testing and validation activities

Key Considerations

Clinical testing

  • Clinical data may be required to support claims concerning reduced possibility for infection or contamination

Non-clinical testing

  • Water backflow pressure through anti-reflux valve
  • 24-hour inversion leakage test
  • Standing column test for drainage efficiency
  • Drainage time test
  • For absorbent materials: confirmation of amount and maximum fluid absorption
  • For adhesives: strength and removability testing

Labeling

  • Device and package labels must include:
    • Device name, corporation name, address, telephone number
    • Sterility status, expiration date
    • Disposable/single use information
    • Quantity, size
    • Prescription device statement
  • Comprehensive instructions for use
  • Contraindications, warnings, and precautions
  • No implied FDA approval in promotional materials

Biocompatibility

  • Chemical composition identification for adhesives and absorbent materials
  • Testing according to Tripartite Biocompatibility Guidance for:
    • External devices contacting breached surfaces
    • Externally communicating devices contacting intact natural channels

Safety

  • Sterilization validation for sterile devices
  • Assessment of sterilization effects on absorbent materials
  • Documentation of significant modifications affecting safety

Other considerations

  • 21 CFR 876.5250: Medical devices classification regulation for urine collectors and accessories
  • 21 CFR 807.87: Requirements for premarket notification submissions
  • 21 CFR 801.109: Prescription devices labeling requirements

Original guidance

  • Premarket Notification Requirements for Urine Drainage Bags and Accessories
  • HTML / PDF
  • Issue date: 1994-06-07
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 7bb332954aafcb61d48e85c7b8bed04e
This post is licensed under CC BY 4.0 by the author.