Medical Device Tracking Requirements and Implementation Procedures
This guidance applies to manufacturers, importers, and distributors of tracked medical devices regulated by CDRH. It outlines tracking requirements for certain Class II and Class III devices that either have potential serious health consequences upon failure or are implanted/life-sustaining devices.
Recommended Actions
- Establish written Standard Operating Procedures (SOPs) for tracking method
- Implement tracking system that can provide required information within specified timeframes
- Set up regular audit schedule (6-month intervals for first 3 years, annually thereafter)
- Maintain complete tracking records for device useful life
- Ensure tracking system can identify device location through entire distribution chain
- Establish process for documenting patient refusals to provide tracking information
- Create procedure for transfer of tracking responsibilities in case of business changes
- Implement system to track imported devices throughout US distribution
- Establish process for tracking exported devices to point of export
- Consider implementing device identification system compatible with upcoming UDI requirements
Key Considerations
Labelling
- No special labeling requirements for tracked devices
- Some form of identification should be provided with or on the device to enable easy recognition for tracking purposes
Other considerations
- Manufacturers must track devices through distribution chain to end user
- Information must be provided within 3 working days for non-distributed devices and 10 working days for distributed devices
- Audits required every 6 months for first 3 years, then annually
- Tracking records must be maintained for the useful life of the device
- Manufacturers remain responsible even when contracting tracking program management
- Tracking obligations end when device is returned, destroyed, explanted, or patient dies
- Imported devices must be tracked throughout US distribution
- Exported devices must be tracked until point of export
Relevant Guidances
- Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Unique Device Identifier (UDI) Form and Content Requirements
- Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
Related references and norms
- MIL-STD-105E: Sampling Procedures and Tables for Inspection by Attributes
Original guidance
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