Description
This draft guidance document provides the FDA’s recommendations regarding non-clinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate. The recommendations are being made based in part on concerns that the accuracy of pulse oximeters can be affected by, among other factors, a person’s skin pigmentation. The recommendations are being provided to inform the performance evaluation for these devices, to support premarket submissions, regardless of submission type, and to promote consistency and facilitate efficient review of these submissions. Among other topics, the draft guidance also provides recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits and risks associated with the use of the device.
Scope & Applicability
Product Classes
3devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate; Medical devices used for non-invasive measurement of blood oxygen saturation; medical devices within the scope of this guidance; manufacturing and processing methods to pulse oximeters with a history of safe use; medical devices subject to the performance testing recommendations; Medical devices used for measuring blood oxygen saturation; medical device subject to the guidance recommendat
labeling recommendations for over-the-counter pulse oximeters
The primary device subject to labeling and performance recommendations.
Stakeholders
6HCPs who make evidence-based decisions on medicinal product use.; HCPs to be educated about study participation for their patients.
refers to the FDA for pre-submission engagement
Subgroups including neonates, infants, and children younger than 12 years of age.
Entity responsible for submitting NDINs
non-professional users of pulse oximeters
Advisory committee panel that provided recommendations on pulse oximeter performance
Regulatory Context
Attributes
10demonstrating comparable performance across diverse groups
performance metric (Arms) for pulse oximeter accuracy
conditions that may degrade pulse oximeter performance
condition of poor pulsatile signal strength
Level of documentation required based on risk; higher documentation threshold for software functions; Risk-based documentation category requiring more detail; Outcome for software functions where failure presents a probable risk of death or serious injury; Outcome for devices where software failure presents a probable risk of death or serious injury.
Level of documentation required based on risk; documentation threshold for software functions; Risk-based documentation category; Outcome for software functions with low risk of death or serious injury
Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
An objective, continuous, quantitative measure of skin pigmentation.; calculated value (ITA) used to determine skin pigmentation objectively via colorimetry
A subjective scale (1-10) used to assess skin tones in study participants.; MST color chart used to evaluate skin pigmentation diversity; ten level subjective skin color annotation scale used to evaluate forehead pigmentation; Scale used for skin pigmentation assessment; scale used to evaluate skin pigmentation for performance testing
True blood oxygenation level used for verification in clinical performance testing.; CO-oximeter arterial oxygen saturation reference measurement; Arterial blood oxygen saturation
Identified Hazards
Hazards
6Factor that may impact the accuracy of pulse oximeter readings
adverse event from continuous wear
external factor that may affect device performance
Risk introduced by missing data or incomplete information
MR system can induce heating of tissue adjacent to the sensor
potential hazard in MR environment causing unwanted movement
Related CFR Sections (11)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR812.28§ 812.28 Acceptance of data from clinical investigations conducted outside the United States.
(a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) Read full regulation →
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR870.2700§ 870.2700 Oximeter.
(a) Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.Read full regulation →
- 21CFR870.2710§ 870.2710 Ear oximeter.
(a) Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR860.220§ 860.220 De Novo request content.
(a) Unless the requester justifies an omission in accordance with paragraph (c) of this section, a De Novo request must include:Read full regulation →
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR801.5§ 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →
- 21CFR7.45§ 7.45 Food and Drug Administration-requested recall.
(a) The Commissioner of Food and Drugs or designee may request a firm to initiate a recall when the following determinations have been made:Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
See Also (8)
- Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- General/Specific Intended Use - Guidance for Industry (Status: Final)
- Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff (Status: Final)
- Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Medical Glove Guidance Manual: Guidance for Industry and FDA Staff (Status: Final)