🩺FDA Draft Guidance on Pulse Oximeters for Regulatory Compliance
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations." This draft guidance document, when finalized, will provide recommendations regarding non-clinical and clinical performance testing of certain pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate. These recommendations are being proposed 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 proposed 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 Among other topics, the draft guidance also proposes recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits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. This draft guidance is not final nor is it for implementation at this time.
Learn More🐾FDA's Guidance on Animal Food Ingredient Consultation Released
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #294 entitled "Animal Food Ingredient Consultation (AFIC)." This guidance describes FDA's interim AFIC process and explains one way FDA will work with firms that are developing animal food ingredients now that the Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expired on October 1, 2024, and while FDA evaluates the animal Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs. The AFIC process provides an additional way for engagement with FDA regarding ingredients for which firms may otherwise have used the AAFCO ingredient definition process. AFIC will help FDA identify any potential safety concerns associated with such ingredients. The AFIC process also allows for public awareness of and input on such ingredients. In addition, this guidance describes FDA's enforcement policy for certain ingredients assessed using the AFIC process.
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