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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.

  1. Conduct comprehensive risk analysis to identify all potential sources of error
  2. Validate cleaning and disinfection procedures:
    • Demonstrate effectiveness against bloodborne pathogens
    • Verify device robustness to cleaning/disinfection cycles
  3. Perform complete performance evaluation studies:
    • Clinical user studies
    • Precision/accuracy testing
    • Environmental condition testing
    • Interference studies
  4. Develop clear, user-friendly labeling:
    • 8th grade reading level
    • Comprehensive instructions
    • Prominent safety warnings
    • Performance data presentation
  5. Implement appropriate software controls and cybersecurity measures
  6. Establish test strip lot release criteria and quality control procedures
  7. Document all validation testing in 510(k) submission
  8. Consider implementing additional safety features like temperature/humidity indicators
  9. 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

  • 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
This post is licensed under CC BY 4.0 by the author.