Registration and Listing Requirements for Single-Use Device Reprocessors and Hospitals
This guidance clarifies three frequently asked questions regarding registration, device listing, and compliance requirements for establishments and hospitals involved in reprocessing single-use medical devices (SUDs).
Recommended Actions
- Review current registration status if manufacturing and reprocessing SUDs
- Update establishment registration to include “Reprocessor of Single-Use Devices” if applicable
- Update device listing information to reflect all operations performed on devices
- For hospitals:
- Determine if internal reprocessing of SUDs is performed
- If yes, ensure compliance with FDA manufacturer requirements
- If using third-party reprocessors, maintain documentation of the relationship
- Maintain records of all registration and listing updates
- Consider implementing a system to track and document reprocessing activities
Key Considerations
Other considerations
- Establishments that manufacture and reprocess their own SUDs must:
- Register as both a manufacturer and a “Reprocessor of Single-Use Devices”
- Update device listing information to reflect all operations performed on devices
- Hospitals that use reprocessed SUDs:
- Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors
- Distinguishing Between Medical Device Servicing and Remanufacturing Activities
Related references and norms
- 21 CFR Part 807: Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
- 21 CFR Part 814: Premarket Approval of Medical Devices
Original guidance
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