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.
Recommended Actions
- Develop comprehensive boxed warning following provided format
- Create detailed patient decision checklist incorporating all required elements
- Implement process for checklist distribution, signing, and record-keeping
- Establish system for periodic updates to labeling based on post-market data
- Train physicians on proper use of labeling materials and risk communication
- Create process to audit compliance with labeling requirements
- Develop plan for managing adverse event reports and updating risk information
- Establish clear protocol for device removal requests and referrals
- Create patient education materials supporting labeling information
- 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
- Manufacturers should develop plan to audit checklist distribution and signing
- Checklist should be periodically updated based on post-market data
- Device removal coverage by insurance should be addressed
Relevant Guidances
- Special Controls for Implanted Blood Access Devices for Hemodialysis
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Device Labeling Requirements and Content for Premarket Approval Applications
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
NO_SPECIFIC_REFERENCES_MENTIONED
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.