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Performance Testing and Labeling Requirements for Pulse Oximeters with Focus on Accuracy Across Skin Pigmentation (DRAFT)

This guidance provides recommendations for non-clinical and clinical performance testing, labeling, and premarket submission requirements for pulse oximeters intended for medical purposes, including standalone devices and those with pulse oximeter functions that estimate arterial blood oxygen saturation and pulse rate. The scope includes prescription and over-the-counter (OTC) devices regulated under specific product codes, with a focus on addressing concerns about accuracy differences across skin pigmentation levels.

This is a draft guidance. Not for implementation.

  1. Conduct controlled desaturation laboratory study with diverse participant population to demonstrate non-disparate performance
  2. Perform comprehensive non-clinical testing including accuracy, motion, alarms and other functional aspects
  3. Complete biocompatibility evaluation for patient-contacting components
  4. Develop clear labeling with required warnings, instructions and performance data
  5. Validate software functionality and cybersecurity controls
  6. Conduct human factors evaluation if needed based on device characteristics
  7. Perform electrical safety and EMC testing
  8. Validate reprocessing procedures for reusable components
  9. Document shelf life and packaging validation
  10. Consider early engagement with FDA through Pre-Submission process, especially for pediatric indications
  11. Submit complete test reports and data in premarket notification
  12. Update labeling and submit new 510(k) for previously cleared devices to demonstrate non-disparate performance

Key Considerations

Clinical testing

  • Controlled desaturation laboratory study required to verify SpO2 accuracy and demonstrate non-disparate performance across skin pigmentation
  • Minimum 150 healthy participants with diverse skin pigmentation using Monk Skin Tone scale
  • At least 3,000 paired observations spanning 70-100% SaO2 range
  • Additional convenience arterial samples needed for pediatric populations <12 years
  • Success criteria include Arms <3% and non-disparate performance across skin tones

Non-clinical testing

  • SpO2 accuracy testing for low perfusion conditions if labeled for such use
  • Pulse rate accuracy testing across specified measurement range
  • Motion testing for continuous monitoring devices
  • Alarm function testing for continuous monitoring devices
  • Display values and indicators verification
  • Saturation pulse information signal testing if applicable

Human Factors

  • Required for devices placed in non-standard anatomical locations
  • Required for devices with unique technology/features
  • Usability testing recommended for OTC devices
  • Labeling comprehension testing for lay users

Software

  • Basic or Enhanced documentation level based on device functionality
  • Full description of software functions required
  • Verification and validation testing
  • Special considerations for off-the-shelf software

Cybersecurity

  • Required documentation for devices meeting cyber device definition
  • Risk assessment and controls
  • Security features and protections

Labelling

  • Clear identification as medical device
  • Performance data across skin pigmentation
  • Warnings about accuracy limitations
  • Usage instructions and precautions
  • Specific requirements for prescription vs OTC
  • Statement about non-disparate performance if demonstrated

Biocompatibility

  • Testing required for patient-contacting components
  • Cytotoxicity, sensitization, and irritation endpoints
  • Additional testing for different tissue contact types
  • Special considerations for pediatric populations

Safety

  • Electrical safety testing per standards
  • EMC testing per standards
  • Wireless technology testing if applicable
  • MR compatibility testing if applicable

Other considerations

  • ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
  • IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances
  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
  • ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

Original guidance

  • Performance Testing and Labeling Requirements for Pulse Oximeters with Focus on Accuracy Across Skin Pigmentation
  • HTML / PDF
  • Issue date: 2025-01-07
  • Last changed date: 2025-01-13
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 5fff897b83c4bc41a4b669ccc0b604ae
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