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.
What You Need to Know? 👇
What are the key labeling requirements for reprocessed single-use devices?
Reprocessed SUDs must include the reprocessor’s name and address, adequate directions for use (or prescription exemption), adequate warnings, common device name, quantity of contents, and all information must be in English and prominently displayed.
Who is considered the manufacturer on labels for reprocessed single-use devices?
The entity that reprocesses the single-use device is considered the manufacturer. If a hospital reprocesses, the hospital’s name appears as manufacturer. If a third party reprocesses, the third party’s name must appear as the manufacturer.
Can hospitals use the original manufacturer’s labeling when reprocessing single-use devices?
No, hospitals cannot simply use original labeling. They must modify labels to include their name and address as the reprocessor, update directions for use if the device was changed, and ensure all information remains truthful and not misleading.
What labeling exemptions exist for devices shipped between hospitals and third-party reprocessors?
Devices shipped for reprocessing can be exempt from adequate directions for use requirements if labeled “Caution: For manufacturing, processing, or repacking.” This exemption applies to both regular and prescription devices during inter-facility transport.
What are the prescription device labeling requirements for reprocessed SUDs?
Prescription device labels must include “Caution: Federal law restricts this device to sale by or on the order of [practitioner]” or “Rx Only,” method of application, indications, contraindications, directions for use, and relevant precautions and warnings.
What enforcement responsibilities do hospitals have when receiving reprocessed devices from third parties?
Hospitals are responsible for ensuring received reprocessed SUDs comply with FDA labeling requirements. If they receive misbranded devices from third parties, hospitals may be held responsible for receiving misbranded devices under federal law.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 21 CFR 801: Labeling
- 21 CFR 820: Quality System Regulation