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.
What You Need to Know? 👇
What validation data is required for reprocessed single-use medical devices under MDUFMA?
MDUFMA requires cleaning, sterilization, and functional performance validation data for listed reprocessed SUDs. This data must demonstrate that devices remain substantially equivalent to predicate devices after the maximum intended number of reprocessing cycles.
Can FDA-recognized standards replace validation data submissions for reprocessed SUDs?
No. FDA cannot accept declarations of conformity in lieu of actual validation data for listed reprocessed SUDs. MDUFMA specifically requires submission of cleaning, sterilization, and functional performance validation data for these device types.
How does a manufacturer know if their reprocessed device requires validation data?
Manufacturers should check the Federal Register notices published by FDA. The most comprehensive list was published on September 29, 2005 (70 FR 56911), which consolidated all device types subject to MDUFMA validation data requirements.
What is the grace period for submitting validation data after a device is listed?
There are two grace periods: nine months for devices already subject to 510(k) requirements with previously cleared submissions, and fifteen months for critical and semi-critical reprocessed SUDs whose 510(k) exemption was terminated.
Can Special 510(k) submissions be used for reprocessed SUDs requiring validation data?
No. Special 510(k)s are not appropriate for reprocessed SUDs requiring validation data because they rely on design control declarations rather than actual data. Only non-listed reprocessed SUDs eligible for Special 510(k) may use this pathway.
What is the recommended endpoint for cleaning validation of reprocessed devices?
The cleaning endpoint must be objective and measurable, not based solely on visual examination. It should include visual components supplemented with chemical, microbiological, and/or physical parameters with defined tolerances to demonstrate the device is clean.
What You Need to Do 👇
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