Validation Data Requirements for Reprocessed Single-Use Medical Devices
This guidance describes the types of validation data that FDA recommends be submitted under section 510(o) of the Act for reprocessed single-use medical devices (SUDs) in 510(k) submissions. It provides guidance to industry and FDA staff on submission and review procedures for validation data in 510(k)s for reprocessed SUDs.
Recommended Actions
- Develop comprehensive reprocessing procedure documentation from point of use through release
- Establish maximum number of reprocessing cycles and validate performance through that number
- Perform risk analysis identifying all potential hazards
- Validate cleaning process including agent characterization, process parameters, and endpoints
- Validate sterilization process per ISO 14937
- Conduct functional performance testing after maximum reprocessing cycles
- Document procedures for tracking number of reprocessing cycles
- Establish procedures for assessing impact of OEM device changes
- Maintain complete validation documentation including protocols and reports
- Consider using master files for common validation data across multiple devices
Key Considerations
Non-clinical testing
- Validation data must include cleaning, sterilization, and functional performance data demonstrating substantial equivalence to predicate device after maximum number of reprocessing cycles
- Testing should be performed on worst-case basis after maximum intended reprocessing cycles
- Simulated use between reprocessing cycles should be performed
- Device must continue to meet performance specifications after maximum cycles
Labelling
- Must specify maximum number of times device can be reprocessed
- Must include procedures for product release and criteria for conformance
- Must include full description of final packaging materials, configuration and shelf life
Biocompatibility
- Devices contacting blood must be assessed for residual pyrogens after sterilization
- Biological safety after exposure to cleaning agents must be demonstrated
- Limits for process residuals must be documented
Safety
- Risk analysis required identifying hazards from product and processes
- Safety of cleaning agents under conditions of use must be documented
- Toxicological assessment of cleaning agents required
Other considerations
- Process validation required for cleaning and sterilization processes
- Master files can be used to document common validation data
- Changes to incoming device must be assessed for impact on reprocessing
- Quality control tests must be included
- Procedures for repairs/refurbishment must be described
Relevant Guidances
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- 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
- ISO 14937: Sterilization of medical devices – General requirements for characterization of a sterilizing agent and development, validation and routine control of sterilization process
- ISO 14971: Medical devices - Application of risk management to medical devices
Original guidance
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