Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Home Use
This guidance focuses on self-monitoring blood glucose test systems (SMBGs) intended for over-the-counter home use by lay-users. It specifically excludes blood glucose monitoring systems for professional healthcare settings, devices for diabetes screening/diagnosis, continuous glucose monitors, non-invasive glucose measurement devices, and devices for neonates.
Recommended Actions
- Conduct comprehensive risk analysis to identify all potential sources of error
- Validate cleaning and disinfection procedures:
- Demonstrate effectiveness against bloodborne pathogens
- Verify device robustness to cleaning/disinfection cycles
- Perform complete performance evaluation studies:
- Clinical user studies
- Precision/accuracy testing
- Environmental condition testing
- Interference studies
- Develop clear, user-friendly labeling:
- 8th grade reading level
- Comprehensive instructions
- Prominent safety warnings
- Performance data presentation
- Implement appropriate software controls and cybersecurity measures
- Establish test strip lot release criteria and quality control procedures
- Document all validation testing in 510(k) submission
- Consider implementing additional safety features like temperature/humidity indicators
- Provide ongoing technical support through U.S. toll-free number
Key Considerations
Clinical testing
- Method comparison/user evaluation study with at least 350 subjects
- Study should include both naïve and non-naïve SMBG users (at least 10% naïve)
- 95% of results should be within ±15% of comparator results
- 99% of results should be within ±20% of comparator results
- Separate studies needed for each alternative anatomical site claimed
Non-clinical testing
- Precision evaluation (within-run and intermediate)
- Linearity across measuring range
- Test strip stability (closed and open vial)
- System operating conditions (temperature, humidity)
- Altitude effects testing up to 10,000 feet
- Sample perturbation studies
- Short sample detection
- Used test strip detection
Human Factors
- Study participants should only use draft labeling without additional training
- Reading level of labeling should be 8th grade or lower
- User questionnaire required after study completion
- Instructions must be clear and concise with appropriate graphics
Labelling
- Must include warnings about single-patient use and infection risk
- Clear instructions for cleaning and disinfection
- Performance characteristics presented in user-friendly format
- Alternative site testing limitations clearly stated
- Error messages and troubleshooting procedures
- U.S. toll-free number for assistance
Software
- Considered moderate level of concern device
- Software documentation per FDA guidance
Cybersecurity
- Must implement appropriate cybersecurity controls
- Follow FDA cybersecurity guidance for pre and post-market management
Safety
- Single patient use only
- Must include validated cleaning and disinfection procedures
- Must be robust to cleaning/disinfection over device lifetime
- Must warn about bloodborne pathogen transmission risk
Other considerations
- Quality control materials (at least 2 levels) should be available
- Test strip lot release criteria must ensure consistent performance
- Third party test strips must address meter compatibility
Relevant Guidances
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Design Considerations for Medical Devices Intended for Home Use
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
Related references and norms
- ASTM E1053-11: Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces
- ASTM E2362-09: Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection
- CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures
- CLSI GP-14: Labeling of Home-Use In Vitro Testing Products
- ISO 14971: Medical devices – Application of risk management to medical devices
Original guidance
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Home Use
- HTML / PDF
- Issue date: 2020-09-29
- Last changed date: 2021-06-25
- Status: FINAL
- Official FDA topics: Medical Devices, Drugs, 510(k), Premarket, Clinical Chemistry & Clinical Toxicology, Over-the-Counter Drugs
- ReguVirta summary file ID: dbbda9169fa2eee8efde33fd967aee34
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