When Clearance Isn’t Enough: Why Some Pulse Oximeters May Need Retesting Under FDA’s 2025 Draft Guidance

Introduction: A New Standard on the Horizon 

On January 6, 2025, the FDA released a draft guidance titled Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations.

This draft guidance updates and expands upon earlier 510(k) and performance expectations for pulse oximeters, placing renewed emphasis on accuracy across skin pigmentation and non-disparate performance.  

Crucially, the draft does not only apply to new devices. It explicitly recommends that previously cleared pulse oximeters, especially those modified in certain ways, gather clinical data to show non-disparate performance across skin tones.  

In effect, many existing devices—even those already on the market—may be called upon to re-verify or re-label under this new paradigm. 

Key Elements of the FDA Draft Guidance That Trigger Retesting 

To understand which devices might need retesting, it's essential to know what the draft guidance requires. Below are the principal changes: 

1. Clinical Data for “Non-Disparate Performance” 

• The draft guidance recommends that manufacturers of both new and currently marketed pulse oximeters gather clinical data (e.g., via controlled desaturation lab studies or real-world data) to evaluate whether the device’s performance is non-disparate across skin pigmentation levels.  

• “Non-disparate performance” is defined as performance that does not differ meaningfully between groups of differing skin pigmentations.  

• The guidance recommends explicit subgroup analyses stratified by skin tone (e.g., using the Monk Skin Tone scale and objective measure such as Individual Typology Angle) to support claims.  

Thus, even if a device had acceptable aggregate performance historically, it may need new stratified data. 

2. Expanded Clinical Study Requirements 

Compared to legacy expectations, the draft guidance pushes for: 

• Larger sample sizes with more data pairs per each volunteer participant 

• Additional sub-analyses across skin tones and oxygen saturation ranges 

• Tighter accuracy metrics with stricter bounds for root-mean-square (Arms) for all sensor types 

Devices that were cleared based on older metrics or smaller datasets may not meet FDA’s current requirements. 

3. Labeling Changes & “Performance Across Skin Tones” Disclosure 

• The draft requires labeling to state any known limitations in performance related to skin pigmentation.  

• If a device demonstrates non-disparate performance, the labeling can include a prominent statement to that effect.  

• If a device undergoes significant modifications (hardware, firmware, algorithm) that impact performance, it must submit a new 510(k). Under the draft, such submissions should be evaluated under the updated performance and equity criteria. 

• For previously cleared devices, updated labeling (with performance disclosures) may be submitted in a new 510(k) without hardware changes, in some cases. Even for devices unchanged, but marketed under the “medical” indication, the draft suggests retroactive data gathering may be appropriate.  

Thus, even without reengineering, manufacturers may need to submit new documentation and disclosures. 

Which Devices Are Likely Candidates for Retesting 

Based on the draft guidance, the following categories of existing pulse oximeters are prime candidates for retesting or re-labeling: 

1. Devices cleared under older guidance and standards 

2. Devices whose verification did not include significant representation of darker skin tones 

3. Devices with small sample size verification studies 

4. Devices with firmware or algorithm updates since initial clearance 

5. Multiparameter devices or integrated systems that include pulse oximetry modules 

6. Prescription and over-the-counter (OTC) medical pulse oximeters 

Devices marketed purely as “wellness” or for non-medical purposes are, for now, outside the draft’s scope.  

How PRL Can Help Existing Devices Adapt 

As a device developer or company with an existing oximeter on the market, you will need to act strategically and that’s where PRL’s services can provide advantage: 

1. Gap Assessment & Retrospective Review 

PRL can perform a review of your original validation data to flag gaps in skin-tone representation, sample size, stratified analysis, and alignment with new draft guidance. 

2. Controlled Desaturation Retesting or Data Supplementation  

We can run new controlled desaturation studies under the updated draft criteria: diverse recruitment, matched SpO₂/SaO₂ pairs, and subgroup performance metrics. 

3. Labeling Strategy & Regulatory Submissions 

Our team can support drafting updated labeling performance statements and help prepare new 510(k) or amendment submissions aligned with the draft guidance. 

Caveats & Outlook 

• The guidance is still non-binding and in draft form; it is not yet enforceable.  

• Final requirements (sample sizes, performance bounds) may change after public comment and agency revisions. 

• Some older data (e.g. retrospective real-world data) may be acceptable as supportive data 

Conclusion 

The FDA’s January 2025 draft guidance on pulse oximeters highlights a growing focus on performance equity across skin tones—now considered an essential part of validation. Manufacturers can strengthen confidence in their devices by confirming performance aligning with these expectations. 

Manufacturers should proactively audit their legacy devices, plan for additional controlled desaturation testing, and begin crafting labeling and submission strategies aligned with the draft. At PRL, we are ready to support this transition with comprehensive verification, regulatory submission support, and performance claims built on inclusive, data-driven science. Ready to start the conversation? Contact us today.