Modifications to Non-Invasive Remote Monitoring Devices for Patient Monitoring During Public Health Emergencies
This guidance applies to legally marketed, non-invasive remote monitoring devices that measure or detect common physiological parameters for patient monitoring. It covers specific device types including cardiac monitors, electrocardiographs, spirometers, blood pressure systems, and other monitoring devices that can be connected wirelessly to transmit patient measurements to healthcare providers.
Recommended Actions
- Review device modifications to ensure they fall within policy scope
- Implement and validate hardware/software changes according to recognized standards
- Update device labeling to include clear instructions for home use
- Document all changes in the quality system
- Ensure cybersecurity controls are in place
- Validate device performance in intended use environment
- Prepare clear user instructions with appropriate terminology
- Consider consulting FDA for unique modifications beyond standard scope
- Maintain compliance with applicable safety and performance standards
- Implement appropriate risk management measures
Key Considerations
Non-clinical testing
- Modifications must not create undue risk
- Modifications must not directly affect the physiological parameter measurement algorithm
- Hardware and software changes must be designed, evaluated, and validated according to FDA-recognized standards
Human Factors
- Adequate instructions for use in home setting with appropriate lay terminology when expanding environment of use
Software
- Software architecture modifications allowed for increased remote monitoring capability if they don’t create undue risk
- Software changes must not affect the physiological parameter measurement algorithm
- Changes must follow IEC 62304 for software lifecycle processes
Cybersecurity
- Must follow cybersecurity requirements
- Implementation of effective cybersecurity controls to ensure device safety and functionality
- Follow applicable cybersecurity policies and guidelines
Labelling
- Clear description of available data on new indications or functions
- Information on device performance and potential risks
- Clear information on use conditions (spot-checking, trend monitoring, or continuous monitoring)
- Appropriate lay terminology for home use instructions
Safety
- Must comply with basic safety standards
- Follow electromagnetic compatibility requirements
- Meet home healthcare environment safety requirements
Other considerations
- Changes must be documented according to quality system requirements
- Manufacturers can initiate discussions with FDA for unique considerations
Relevant Guidances
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Design Considerations for Medical Devices Intended for Home Use
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
Related references and norms
- ANSI/AAMI ES60601-1: Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2: Medical Electrical Equipment - Electromagnetic Disturbances
- IEC 60601-1-11: Requirements for Medical Equipment Used in Home Healthcare Environment
- AAMI TIR69: Risk Management of Radio-Frequency Wireless Coexistence
- ANSI/IEEE C63.27: Wireless Coexistence Evaluation
- IEC 62304: Medical Device Software – Software Life Cycle Processes
- AIM 7351731: EMI Test for RFID Reader Exposure
- ANSI/UL 2900-2-1: Software Cybersecurity for Network-Connectable Healthcare Products
- IEC 81001-5-1: Health Software Security Activities
Original guidance
- Modifications to Non-Invasive Remote Monitoring Devices for Patient Monitoring During Public Health Emergencies
- HTML / PDF
- Issue date: 2023-10-19
- Last changed date: 2023-10-18
- Status: FINAL
- Official FDA topics: Medical Devices, 510(k), Labeling, Premarket
- ReguVirta summary file ID: 3c21fb665f4756fc2d2276f2625691f5
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