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This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the new clinical testing requirements for pulse oximeter accuracy across different skin pigmentations?
FDA now recommends controlled desaturation studies with 150+ participants across diverse skin tones using Monk Skin Tone (MST) groups 1-4, 5-7, and 8-10. Success criteria include Arms <3% overall accuracy and non-disparate performance with bias differences <3.5% for 70-85% SaO2 and <1.5% for 85-100% SaO2.
How should manufacturers demonstrate non-disparate performance for previously cleared pulse oximeters?
Manufacturers should conduct clinical studies (controlled desaturation or real-world data) to evaluate non-disparate performance and submit results in a new 510(k). FDA intends to review these submissions within 30 days when only labeling changes are made without significant device modifications.
What labeling changes are required for pulse oximeters intended for medical purposes?
Package labeling must prominently state the device is “intended for medical purposes.” If non-disparate performance is demonstrated, include statements like “evaluated to perform comparably across groups of individuals with a wide variety of skin tones.” Enhanced warnings about skin pigmentation effects are also required.
What are the key biocompatibility requirements for pulse oximeter patient-contacting components?
For prolonged skin contact devices, manufacturers must address cytotoxicity, sensitization, and irritation/intracutaneous reactivity endpoints. Testing should consider cumulative exposure duration and may require additional assessments for certain patient populations like neonates or infants.
How do the new recommendations apply to pediatric pulse oximeters under 12 years of age?
Adult controlled desaturation studies may be insufficient. FDA recommends validating pediatric sensors on adults across diverse skin pigmentation, plus convenience arterial samples from relevant pediatric subgroups (neonates, infants, children) to verify form, fit, and clinical performance.
What modifications to existing pulse oximeters require a new 510(k) submission?
Significant changes requiring new 510(k)s include: electro-optical sensor modifications affecting the optical chain, SpO2 algorithm changes, modifications to software input parameters, and expanding to pediatric populations under 12 years. Labeling updates for non-disparate performance also require new submissions.
What You Need to Do 👇
Recommended Actions
- Conduct controlled desaturation laboratory study with diverse participant population to demonstrate non-disparate performance
- Perform comprehensive non-clinical testing including accuracy, motion, alarms and other functional aspects
- Complete biocompatibility evaluation for patient-contacting components
- Develop clear labeling with required warnings, instructions and performance data
- Validate software functionality and cybersecurity controls
- Conduct human factors evaluation if needed based on device characteristics
- Perform electrical safety and EMC testing
- Validate reprocessing procedures for reusable components
- Document shelf life and packaging validation
- Consider early engagement with FDA through Pre-Submission process, especially for pediatric indications
- Submit complete test reports and data in premarket notification
- 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
- Sterility validation if provided sterile
- Reprocessing validation for reusable components
- Shelf life and packaging validation
- Performance testing for modifications to existing devices
Relevant Guidances đź”—
- Pulse Oximeters - Performance Testing and Safety Requirements for SpO2 and Pulse Rate Measurement Devices
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms đź“‚
- 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