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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).

  1. Review current registration status if manufacturing and reprocessing SUDs
  2. Update establishment registration to include “Reprocessor of Single-Use Devices” if applicable
  3. Update device listing information to reflect all operations performed on devices
  4. 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
  5. Maintain records of all registration and listing updates
  6. Consider implementing a system to track and document reprocessing activities

Key Considerations

Other considerations

  • 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

  • Registration and Listing Requirements for Single-Use Device Reprocessors and Hospitals
  • HTML / PDF
  • Issue date: 2003-07-16
  • Last changed date: 2021-04-27
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 940178f38790c9f6169c84aad65ab104
This post is licensed under CC BY 4.0 by the author.