The Content and Development of Premarket Submissions for Artificial Pancreas Device Systems
This guidance focuses on the development, investigation, and information requirements for Premarket Applications (PMAs) and Investigational Device Exemptions (IDEs) for Artificial Pancreas Device Systems (APDS) intended for single patient use in the home environment. The guidance covers threshold suspend systems and closed loop control systems. It aims to provide recommendations while allowing flexibility in development approaches.
Recommended Actions
- Develop comprehensive test plan covering all required testing categories
- Conduct early feasibility studies in controlled settings before progressing to outpatient use
- Implement robust human factors program throughout development
- Prepare complete software documentation package
- Develop comprehensive labeling and training materials
- Establish manufacturing controls and quality system
- Plan post-approval study strategy
- Submit pre-IDE to get FDA feedback on development plan
- Consider conducting studies in phases with FDA interaction between phases
- Document all verification and validation testing thoroughly
- Implement cybersecurity controls early in development
- Establish risk management process to identify and mitigate risks
Key Considerations
Clinical testing
- Feasibility studies needed to demonstrate device functions as expected and has no obvious safety concerns
- Pivotal studies required with final device system in intended setting
- Study progression from supervised inpatient to outpatient settings
- Patient population selection and inclusion/exclusion criteria
- Study endpoints must demonstrate safety and effectiveness
- Statistical analysis plan required for pivotal studies
Non-clinical testing
- Animal testing and/or in-silico modeling to demonstrate safety
- Verification testing of control algorithm
- Parameter sensitivity analysis
- System communication testing
- Dose accuracy bench testing
- Catheter occlusion testing
Human Factors
- Comprehensive human factors testing required for user interface components
- Evaluation of use errors and mitigation strategies
- Training materials assessment
- Usability testing with intended users in simulated use conditions
- Assessment of user interface for all components (displays, alarms, controls etc.)
Software
- Major level of concern for software review
- Complete software documentation required
- Verification and validation testing
- Cybersecurity considerations for data protection and communication
Cybersecurity
- Information security measures required
- Protection of data confidentiality, integrity, availability
- Secure communication between device components
- Prevention of unauthorized access
Labeling
- User manual written at 8th grade reading level
- Training materials
- Professional labeling for prescribing physician
- Package inserts and box labels
- Clear instructions for use and maintenance
- Warnings and precautions
Biocompatibility
- Testing required for patient-contacting components
- Testing appropriate for duration of contact
- Evaluation of final, finished, sterilized device
Safety
- Electrical safety testing per standards
- EMC testing
- RF wireless considerations if applicable
- MRI safety labeling
- Risk analysis and mitigation strategies
Other considerations
- Manufacturing information and quality system requirements
- Post-approval study likely required
- Device description including all components
- Sterilization validation if applicable
- Shelf life testing
Relevant Guidances
- Design Controls for Medical Device Manufacturers
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Design Considerations for Medical Devices Intended for Home Use
Related references and norms
- IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Electromagnetic compatibility
- ISO 10993: Biological evaluation of medical devices
- IEC 60601-1-11: Requirements for medical equipment used in home healthcare environment
- CLSI POCT05-A: Performance metrics for continuous interstitial glucose monitoring
Original guidance
- The Content and Development of Premarket Submissions for Artificial Pancreas Device Systems
- HTML / PDF
- Issue date: 2012-11-09
- Last changed date: 2020-02-28
- Status: FINAL
- Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket, Premarket Approval (PMA)
- ReguVirta summary file ID: 36a9b351e645d72865663de8d55bdd23
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