Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Home Use

What You Need to Know? 👇

What is the new Documentation Level requirement for self-monitoring blood glucose test systems?

Based on FDA’s 2023 guidance “Content of Premarket Submissions for Device Software Functions,” self-monitoring blood glucose test systems for over-the-counter use should generally address recommendations for a Basic Documentation Level, replacing the previous Moderate Level of Concern classification.

How often should users clean and disinfect their blood glucose meters?

The guidance recommends cleaning and disinfection at minimum once per week, though specific frequency should be based on validated procedures. Manufacturers must provide detailed instructions for both cleaning and disinfection procedures that are effective against bloodborne pathogens like Hepatitis B virus.

What accuracy criteria must SMBGs meet in user evaluation studies?

SMBGs must demonstrate that 95% of all results are within ±15% of the comparator method across the entire measuring range, and 99% of results are within ±20%. Studies should include at least 350 different subjects with adequate representation across the claimed measuring range.

Can blood glucose meters be shared between family members?

No, SMBGs are intended for single patient use only and should never be shared, even among family members. Sharing devices can lead to transmission of bloodborne pathogens including HIV, Hepatitis B, and Hepatitis C viruses, even after cleaning and disinfection.

What interference testing is required for blood glucose meters?

Manufacturers must test at least 25 specific interferents including acetaminophen, ascorbic acid, bilirubin, and various medications at clinically relevant concentrations. Testing should be performed at three glucose levels (50-70, 110-130, and 225-270 mg/dL) using at least three test strip lots.

What are the minimum requirements for alternative site testing validation?

If claiming alternative site testing capability, manufacturers must test samples from 350 subjects for each alternative anatomical site. The labeling must include specific limitations about when alternative sites should not be used, such as during rapid glucose changes or suspected hypoglycemia.

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What You Need to Do 👇

Recommended Actions

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

• 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

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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

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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 ID: dbbda9169fa2eee8efde33fd967aee34