Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
This guidance provides recommendations for labeling information of Laparoscopic Power Morcellators (LPMs) used in gynecologic surgeries, regardless of their morcellation mechanism. It applies to LPMs with either general or specific gynecologic indications but excludes those specifically indicated only for non-gynecologic surgery and hysteroscopic morcellators.
Recommended Actions
- Update device labeling to include the required boxed warning
- Implement all specified contraindications in the labeling
- Add all required warnings regarding age-related risks
- Include information about containment system requirements
- Submit both current and revised labeling to CDRH
- Provide updated labeling to existing device purchasers
- Ensure compatibility with appropriate containment systems
- Include information about the risks of spreading both malignant and benign tissue
- Update physician and patient information materials to reflect all new labeling requirements
- Submit labeling changes as an “add-to-file” to existing 510(k) clearances
Key Considerations
Labelling
- Must include a boxed warning about the risk of spreading unsuspected cancer
- Must include specific contraindications for use in known/suspected malignancy cases
- Must include contraindications for specific patient populations (post-menopausal, over 50 years)
- Must include warnings about increased cancer risk with age
- Must include warnings about spread of benign tissue
- Must include information about containment system requirements
Safety
- Must be used with a compatible containment system
- Should not be used in cases of known or suspected malignancy
- Should not be used in patients who are candidates for en bloc tissue removal
Other considerations
- Age-related risk considerations must be taken into account
- Pre-operative screening should be conducted while acknowledging its limitations
- Physician-patient discussion of benefits and risks is essential
Relevant Guidances
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms
- 21 CFR 884.4050: Gynecologic laparoscopic power morcellation containment system
Original guidance
- Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
- HTML / PDF
- Issue date: 2020-12-30
- Last changed date: 2020-12-29
- Status: FINAL
- Official FDA topics: Medical Devices, Errors, Obstetrical & Gynecological, Postmarket, and Problems, General & Plastic Surgery, 510(k), Labeling, Premarket, Safety - Issues
- ReguVirta summary file ID: 4940a64845fb5c0e737c401f8d202b51
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