FDA Guidelines - Search News

FDA, Pulse oximetry

CNN on MSN · 17h

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased.

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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either use the newly developed Monk Skin Tone scale or another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.

The Hill · 17h

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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin

AI, FDA

FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement

The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information regarding models’ development and maintenance.

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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug development.

Hosted on MSN · 20h

FDA issues first draft guidance on use of AI in drug, medical device development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increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of new drugs and medical devices.

FDA, Lead

Newsweek on MSN · 16h

FDA Sets New Levels for Toxic Lead in Baby Food

The FDA's new standards for toxic lead target processed baby foods such as jarred fruits, vegetables, yogurts and dry cereals.

CBS News · 18h

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.

CNN on MSN · 17h

FDA disappoints child advocates with its new limit on lead in baby food

For the first time, the US Food and Drug Administration has set a limit on the amount of lead that can be in baby foods, but critics say it’s too little, too late.

FDA recommends plant-based foods prominently state main ingredient

FDA suggests brands clarify ingredient sources on plant-based product labels – a shift some industry groups say may be ...

FiercePharma18h

FDA looks to clarify confirmatory trial mandate for accelerated approvals

In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...

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