FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food
TUESDAY, Jan. 7, 2025 (HealthDay News) -- The U.S. Food and Drug Association (FDA) released the first-ever guidelines for ...
FDA Unveils Draft Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones
The FDA recommendations apply to only professional oximeters used in hospitals, doctor's offices, and other medical settings.
FDA finalizes guidance on device shortage reporting rules
The final version adds information on the devices affected by the guidance and the impact of revised legislation on voluntary ...
FDA sets limits for lead in many baby foods as California disclosure law takes effect
The FDA has set maximum levels for lead in baby food. A new California law requires baby food makers selling products in the ...
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FDA Issues Final Guidance on Testing for Industry Use in Tobacco Product Applications
The Food and Drug Administration on Monday issued a guidance for the tobacco industry entitled Validation and Verification of ...
FDA issues draft guidance on developing weight loss drugs
New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments. Read more here.
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
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FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
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FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
FDA Limits Toxic Lead in Some Baby Foods
The agency issued final guidance that it estimated could reduce lead exposure from processed baby foods by about 20% to 30%.