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).
What You Need to Know? 👇
What are the registration requirements for manufacturers who also reprocess their own single-use devices?
Establishments must register for all operations performed at the same location, including adding “Reprocessor of Single-Use Devices” to their existing registration information and updating device listing information to reflect all operations performed on particular devices.
Do hospitals that use reprocessed single-use devices need to comply with FDA manufacturing requirements?
No. Only hospitals that actually reprocess single-use devices themselves must comply with FDA manufacturing requirements. Hospitals using third-party reprocessors are not subject to these regulatory requirements for device manufacturing.
What regulatory framework governs third-party and hospital reprocessors of single-use devices?
Reprocessors are subject to all regulatory requirements applicable to original equipment manufacturers, including premarket submission requirements under Sections 513 and 515 of the Federal Food, Drug, and Cosmetic Act.
How does FDA’s least burdensome approach apply to single-use device reprocessing guidance?
FDA considers the least burdensome approach in medical device regulation while ensuring compliance with scientific and legal requirements. Alternative approaches may be discussed with FDA if they satisfy applicable statutes and regulations.
What is the legal status of FDA guidance documents on single-use device reprocessing?
FDA guidance documents are nonbinding recommendations representing the Agency’s current thinking. They don’t establish legally enforceable responsibilities unless specific regulatory or statutory requirements are cited. The word “should” indicates suggestions, not requirements.
When was the original enforcement priorities guidance for single-use device reprocessing released and why was it updated?
The original “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals” was released on August 14, 2000. Additional FAQ guidance was created to clarify the original document based on numerous questions received.
What You Need to Do 👇
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:
- Must comply with FDA manufacturer requirements only if they perform the reprocessing themselves
- Are not subject to FDA requirements if they use third-party reprocessors
Relevant Guidances đź”—
- 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 đź“‚
- 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