Per the notices below, the United States Food and Drug Administration (FDA) has issued three draft guidances on medical/dental devices for public comment.
FDA Issues Draft Guidance on Pulse Oximeters for Medical PurposesToday, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations.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 Once finalized, this draft guidance will provide recommendations regarding performance testing and labeling of pulse oximeters that are used for medical purposes.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Facts about the draft guidance This draft guidance, when finalized, is intended to: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Note: This guidance is not for implementation at this time. Submit comments on this draft guidance Submit comments under docket number FDA-2023-N-4976 at www.regulations.gov within 60 days of the draft guidance publication to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.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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FDA Issues Draft Guidance on Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies
Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies. The draft guidance encourages science-driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements.
Upon finalization, this document will update the policy reflected in the existing 2014 guidance Evaluation of Sex-Specific Data in Medical Device Clinical Studies.
Note: This draft guidance is not for implementation at this time. The FDA will consider comments on this draft guidance before it begins work on the final version of the guidance.
Submit comments on this draft guidance
Submit comments under docket number FDA-2023-D-5591 at www.regulations.gov by April 7, 2025, to ensure the FDA considers comments on this draft guidance before it begins work on the final version.
Questions?
If you have questions about this draft guidance, contact CDRHHealthofWomen@fda.hhs.gov.
FDA Issues Draft Guidance on Artificial Intelligence-Enabled Device Software FunctionsToday, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. The draft guidance includes lifecycle considerations for AI-enabled devices, as well as specific recommendations to support marketing submissions for these devices. Facts about the draft guidance This draft guidance, when finalized, is intended to:
- Recommend the documentation and information to include in a marketing submission to the FDA if a device has one or more AI-enabled software functions.
- Support a Total Product Life Cycle (TPLC) approach to the management of AI-enabled devices, including providing recommendations for the design, development, deployment, and maintenance of AI-enabled devices.
- Help sponsors of AI-enabled devices to identify other relevant guidances to assist them with applying the recommendations in those guidances to AI-enabled devices and support activities throughout the lifecycle of the device.
Note: This guidance is not for implementation at this time. Submit comments on this draft guidance Submit comments under docket number FDA-2024-D-4488 at www.regulations.gov by Monday, April 7, 2025 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Upcoming Webinar on this guidance On Tuesday, February 18, 2025 at 2:00 p.m. ET the FDA will host a webinar for manufacturers and others interested in learning more about the guidance.
Questions?If you have questions about this draft guidance, contact DigitalHealth@fda.hhs.gov. If you have questions about the Webinar, contact the Division of Industry and Consumer Education. |
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