New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
The FDA Set Guidelines for 'Acceptable' Levels of Lead in Baby Food for the First Time — but Some Experts Say It's Not Enough
On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...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 Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley
The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry ...
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
FDA sets limits on lead in some baby foods
But consumer advocates say the Food and Drug Administration's new guidance on lead limit in baby food doesn't go far enough.
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
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Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry ...
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FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
FDA limits toxic lead in some baby foods
The Food and Drug Administration has set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and ...