Reprocessor Identification Requirements for Reprocessed Single-Use Devices
This guidance outlines the requirements for manufacturers who reprocess single-use devices (SUDs) to prominently and conspicuously mark their devices with their identification. It specifically implements Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended by the Medical Device User Fee Stabilization Act of 2005.
What You Need to Know? 👇
What are the marking requirements for reprocessed single-use devices under Section 502(u)?
Reprocessed SUDs must prominently and conspicuously bear the reprocessor’s name, abbreviation, or symbol on the device or attachment. If the original device lacks prominent OEM marking, a detachable label on packaging may be used instead.
When did the labeling requirements for reprocessed single-use devices become effective?
The requirements became effective August 1, 2006, or when the original device first bears prominent OEM marking after that date, whichever is later. No additional 12-month grace period applies for devices marked after August 1, 2006.
What factors determine if a manufacturer’s mark is “prominent and conspicuous”?
Four key factors: available space (minimum size of ink pen side), contrast between mark and background colors, font readability under ordinary use conditions, and meaning clarity so users can identify the manufacturer.
Can reprocessors obtain waivers from the device marking requirements?
No. Section 502(u) of the Federal Food, Drug, and Cosmetic Act does not provide any waiver provisions from the labeling requirements for reprocessed single-use devices.
What is a detachable label and when can it be used?
A detachable label is a removable packaging label identifying the reprocessor, intended for patient medical records. It can only be used when the original device lacks prominent and conspicuous OEM marking.
Who must comply with these single-use device marking requirements?
All manufacturers who reprocess single-use devices must comply, including original equipment manufacturers (OEMs) who also reprocess SUDs. The requirements apply specifically to reprocessed devices, not original devices.
What You Need to Do 👇
Recommended Actions
- Assess current labeling practices for reprocessed SUDs
- Develop a marking strategy based on device characteristics and available space
- Implement appropriate marking method (direct marking, attachment, or detachable label)
- Ensure marking meets prominence and conspicuousness criteria
- Update quality system procedures to include new labeling requirements
- Train relevant personnel on new labeling requirements
- Implement by the applicable deadline
- For detachable labels, include instructions for healthcare providers to affix the label to patient records
- Document compliance with marking requirements in device master records
Key Considerations
Labelling
- The reprocessor’s mark must be prominent and conspicuous on the device or attachment
- Key factors for prominent and conspicuous marking:
- Available space on the device
- Contrast between mark and background
- Font or graphic readability
- Meaning and understandability of the mark
- A detachable label on packaging can be used if the original device doesn’t prominently display the OEM’s mark
- The detachable label must be designed to be affixed to patient medical records
Other considerations
- Compliance deadline is either August 1, 2006, or the date when the original device first bears the OEM’s mark (whichever is later)
- No waivers are available from this labeling requirement
- Requirements apply to all manufacturers who reprocess SUDs, including OEMs who reprocess their own devices
Relevant Guidances đź”—
- Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors
- Registration and Listing Requirements for Single-Use Device Reprocessors and Hospitals
- Validation Data Requirements for Reprocessed Single-Use Medical Devices