Labeling Requirements for Reprocessed Single-Use Medical Devices
This guidance outlines labeling requirements for single-use devices (SUDs) that are reprocessed by third parties and hospitals. It applies to hospitals and third parties engaged in reprocessing activities, which are considered manufacturing activities under FDA regulations.
Recommended Actions
- Establish a labeling system that complies with all FDA requirements for reprocessed SUDs
- Develop procedures to ensure proper labeling when receiving, shipping, or using reprocessed SUDs
- Review and update existing labels to ensure compliance with manufacturer identification requirements
- Implement a system to verify that prescription device labeling meets specific requirements
- Create a process to ensure labeling accuracy when modifying previous manufacturer’s information
- Establish procedures for proper labeling during shipping for reprocessing
- Develop a quality control system to verify labeling compliance before device distribution
- Train relevant personnel on labeling requirements and procedures
Key Considerations
Labelling
- Must include name and place of business of manufacturer (reprocessor)
- Must bear common or usual name of device
- Must state quantity of contents
- Must include adequate directions for use or qualify for exemption
- Must include adequate warnings
- Must not be false or misleading
- Must give adequate prominence to required information
- Must appear in English (with specific exceptions)
- For prescription devices:
- Must include “Caution: Federal law restricts this device…” statement
- Must include method of application or use
- Must include indications, contraindications, directions for use, and relevant precautions
Other considerations
- Reprocessors are considered manufacturers under FDA regulations
- Previous manufacturer’s labeling may need modification when reprocessing
- Devices shipped for reprocessing can be exempt from certain labeling requirements if properly marked
Relevant Guidances
- Labeling Requirements and Recommendations for Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
- Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors
- Registration and Listing Requirements for Single-Use Device Reprocessors and Hospitals
Related references and norms
- 21 CFR 801: Labeling
- 21 CFR 820: Quality System Regulation
Original guidance
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