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Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization

This guidance outlines labeling requirements for permanent, hysteroscopically-placed tubal implants intended for female sterilization. It specifically focuses on the inclusion of a boxed warning and patient decision checklist in product labeling to ensure women receive and understand information about benefits and risks before implantation.

  1. Develop comprehensive boxed warning following provided format
  2. Create detailed patient decision checklist incorporating all required elements
  3. Implement process for checklist distribution, signing, and record-keeping
  4. Establish system for periodic updates to labeling based on post-market data
  5. Train physicians on proper use of labeling materials and risk communication
  6. Create process to audit compliance with labeling requirements
  7. Develop plan for managing adverse event reports and updating risk information
  8. Establish clear protocol for device removal requests and referrals
  9. Create patient education materials supporting labeling information
  10. Maintain documentation of all labeling-related processes and updates

Key Considerations

Human Factors

  • Patient must understand and acknowledge the permanent nature of the device
  • Patient must demonstrate understanding of risks and benefits through checklist completion
  • Physician must confirm discussion of risks and benefits with patient

Labelling

  • Must include a boxed warning highlighting significant/common adverse events
  • Must include a patient decision checklist covering:
    • Permanent nature of sterilization
    • Alternative contraceptive options
    • Contraindications
    • Required follow-up steps
    • Effectiveness and pregnancy risks
    • Adverse events (short and long-term)
    • Warning signs requiring medical attention
    • Device materials and associated risks
    • Removal information
  • Checklist must be signed by both patient and physician
  • Copy of checklist should be provided to patient

Biocompatibility

  • Must disclose device materials and potential allergic/hypersensitivity reactions
  • Must include MRI safety information if applicable

Safety

  • Must detail significant adverse events from clinical trials and post-market experience
  • Must include warning signs requiring prompt medical evaluation
  • Must describe risks associated with device removal

Other considerations

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Original guidance

  • Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization
  • HTML / PDF
  • Issue date: 2016-10-31
  • Last changed date: 2019-02-09
  • Status: FINAL
  • Official FDA topics: Adverse Event Reporting System (FAERS), Medical Devices, Gastroenterology-Urology, Postmarket, Adverse Event Reporting, 510(k), Biostatistics, Labeling
  • ReguVirta summary file ID: e5837982d08fdb3abc48da2a76f7efc3
This post is licensed under CC BY 4.0 by the author.