Shelf Life and Stability Testing for Medical Devices
This guidance document from 1991 focuses on establishing and validating shelf life for medical devices. It provides recommendations on determining whether a device requires shelf life dating, what parameters should be considered, and how to conduct stability testing to support expiration dating.
Recommended Actions
- Develop written procedures for shelf life determination and validation
- Establish stability testing program including:
- Sample size and test intervals
- Storage conditions monitoring
- Test methods validation
- Packaging evaluation
- Accelerated and real-time testing protocols
- Document stability criteria for:
- Chemical properties
- Physical characteristics
- Microbiological aspects
- Therapeutic function
- Toxicological considerations
- Biocompatibility
- Implement quality control procedures for:
- Raw material evaluation
- Manufacturing process control
- Environmental monitoring
- Storage conditions
- Shipping validation
- Create labeling that includes:
- Expiration date
- Storage requirements
- Handling instructions
- Maintain records of all shelf life related testing and validation data
- Establish procedures for extending shelf life based on additional data
- Implement inventory control system to ensure proper stock rotation
Key Considerations
Non-clinical testing
- Establish written procedures for determining shelf life necessity and validation
- Conduct stability testing considering chemical, physical, microbiological, therapeutic, and toxicological aspects
- Perform accelerated aging studies with real-time validation
- Test device in final packaging configuration
- Evaluate storage and shipping conditions impact
Labelling
- Include expiration date on device labeling when shelf life is established
- Provide appropriate storage instructions including temperature, humidity, light conditions
- Include lot numbers when applicable
Biocompatibility
- Evaluate changes in biocompatibility over time
- Consider material degradation effects
Safety
- Assess risk level of device failure due to aging
- Consider sterility maintenance over time if applicable
- Evaluate preservative effectiveness when applicable
Other considerations
- Consider manufacturing process impact on shelf life
- Evaluate packaging and device interaction
- Assess component degradation (e.g. batteries)
- Monitor environmental conditions during storage
- Document all shelf life related procedures and data
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
- Quality System Information Requirements for Premarket Submissions
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Related references and norms
- ASTM D3492-89: Standard Specifications for Rubber Contraceptives (Condoms)
- USP XXI: Sterility Tests and Preservative Effectiveness Testing
- MIL STD 105E: Sampling Procedures and Tables for Inspection
Original guidance
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