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.
What You Need to Know? 👇
What factors determine if a medical device requires shelf life testing and expiration dating?
Devices susceptible to degradation affecting safety or performance require shelf life determination. Consider the device’s intended use, risk level if failure occurs, and likelihood of time-dependent degradation. Life-threatening applications demand near-zero failure rates within labeled shelf life.
What are the key stability criteria that must be evaluated for medical device shelf life studies?
Six main criteria should be assessed: chemical (degradation, interactions), physical (characteristics, storage conditions), microbiological (sterility, antimicrobial effectiveness), therapeutic (functional performance), toxicological (degradation by-products), and biocompatibility changes during storage or use.
How can accelerated aging studies be used to establish medical device shelf life?
Accelerated aging uses elevated temperatures (typically 10-20°C above ambient) to simulate time passage. Every 10°C increase doubles aging rate. However, accelerated studies must be validated by real-time testing to confirm tentative shelf life data and ensure accuracy.
What regulatory requirements exist for shelf life determination in medical devices?
Requirements vary by device type and regulatory pathway. In vitro diagnostics (21 CFR 809) require storage instructions and expiration dates. PMA devices need shelf life data in applications. GMP regulations require quality assurance programs including appropriate shelf life considerations.
What documentation is required for a comprehensive shelf life testing program?
Essential documentation includes: organizational responsibilities, finished device sampling plan, raw materials evaluation, storage conditions protocol, accelerated aging parameters with validation, shipping stress simulation, and follow-up procedures for results interpretation and stock rotation.
How should manufacturers handle shelf life extension for approved medical devices?
For PMA devices, extensions using pre-approved protocols can be reported in routine submissions. New methods require PMA supplements. For 510(k) devices, modifications typically require new submissions. Always maintain real-time data to support any accelerated testing claims.
What You Need to Do 👇
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