Description
This document supersedes Non-invasive Pulse Oximeter General Guidance Document, September 7, 1992.The draft of this document was issued on July 19, 2007.
Scope & Applicability
Product Classes
4Proposed classification for NGS-based tests for germline diseases.
Guidance on validation data for premarket notification submissions
The primary device subject to labeling and performance recommendations.
devices 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
Stakeholders
4Entity that established original safety and performance specifications
Entity that replaces or saves components during reprocessing
Possible to conduct the FIH trial in healthy volunteers
Youngest pediatric group requiring cautious bridging
Regulatory Context
Attributes
4The displayed oxygen saturation value which may have a range of uncertainty.; pulse oximeter oxygen saturation measurement; Functional oxygen saturation measured by the device; estimated oxygen level reading
Performance testing after maximum number of reprocessing cycles
factor that can affect the accuracy of pulse oximeters; Factor affecting pulse oximeter accuracy; evaluating device performance across diverse levels; diverse pigmentation to be evaluated in clinical studies; Factor that may affect the accuracy of oxygen level readings
Former risk classification for CADe devices under the superseded guidance.; Typical risk classification for CADe software
Related CFR Sections (5)
- 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 →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read 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 →
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-06-18
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
See Also (8)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Status: Final)
- Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] (Status: Final)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)