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Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations. Pulse oximeters are widely used by health care providers and consumers as a non-invasive way to measure blood oxygen saturation. Once finalized, this draft guidance will provide recommendations regarding performance testing and labeling of pulse oximeters that are used for medical purposes. When finalized, this guidance will supersede the 2013 guidance document: Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff.
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Facts about the draft guidance
This draft guidance, when finalized, is intended to:
- Inform how pulse oximeters are tested and evaluated to support premarket submissions.
- Make sure device labeling, including instructions, helps to promote the safe and effective use of pulse oximeters and helps people understand the benefits and risks of using them.
- Promote consistency and facilitate efficient review of premarket submissions for pulse oximeters.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance
Submit comments under docket number FDA-2023-N-4976 at www.regulations.gov within 60 days of the draft guidance publication to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.
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