FDA issues much-anticipated guidance on pulse oximeters
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...
vator2h
The FDA outlines draft guidance on AI for medical devices
Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...
Medical Design and Outsourcing13d
Vision check with FDA CDRH Director Dr. Michelle Tarver
Dr. Michelle Tarver, a veteran leader at the FDA, is director of the Center for Devices and Radiological Health at a pivotal ...
MyChesCo on MSN5mon
FDA Opens Search for New CDRH Director
WASHINGTON, D.C. — The Food and Drug Administration (FDA) has launched a national search for a new Director for the Center ...
CNN20d
FDA places its most serious warning on menopause drug due to risk of liver injury
The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes. The FDA says women who are taking ...
TMCnet7h
FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
The FDA's medical product centers have a shared commitment to promote the responsible and ethical use of AI for medical products. As the field of AI evolves, the agency will continue to develop ...