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.
What You Need to Know? 👇
What devices are currently subject to FDA medical device tracking requirements?
FDA requires tracking for Class II or III devices that could cause serious adverse health consequences if they fail, are implanted for over one year, or are life-sustaining devices used outside facilities. The current list includes cardiac devices, implants, ventilators, and other critical medical equipment.
How quickly must manufacturers provide tracking information during a recall?
Manufacturers have 3 working days to provide critical information about tracked devices that haven’t been distributed to patients, and 10 working days for devices already distributed to patients. This enables rapid response during safety recalls.
Can medical device registries be used to satisfy tracking requirements?
Yes, medical device registries can manage tracking programs if they collect all information required by 21 CFR 821. However, manufacturers remain fully responsible for ensuring the program complies with all tracking requirements and regulations.
What auditing requirements exist for medical device tracking programs?
Manufacturers must audit tracking programs every 6 months for the first 3 years after receiving tracking orders, then annually thereafter. Audits should use recognized statistical sampling plans like Military Standard 105E to verify accuracy and functionality.
Are exported medical devices subject to FDA tracking requirements?
Devices distributed outside the U.S. are generally not subject to tracking requirements (except military bases/consulates). However, manufacturers must track devices through the distribution chain to the exporting entity and make reasonable recall efforts for implanted devices.
When do medical device tracking obligations end for manufacturers?
Tracking obligations end when devices are returned, destroyed, explanted, or when the patient dies. For PMA-approved devices, tracking requirements may be reassessed 10 years after original approval. Manufacturers going out of business must transfer tracking records to FDA.
What You Need to Do 👇
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