FierceBiotech1d
FDA’s device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
Yahoo Finance13d
FDA issues much-anticipated guidance on pulse oximeters
The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on pulse oximeters ...
Tarver warns that US device supply chain vulnerabilities could harm patients
The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...
vator12d
The FDA outlines draft guidance on AI for medical devices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 ...
EurekAlert!1mon
Children’s National, FDA collaborate to advance pediatric device regulatory tools
WASHINGTON (Dec. 4, 2024) — In a significant collaboration to help advance pediatric health, Children’s National Hospital and the U.S. Food and Drug Administration’s (FDA) Office of Science ...
HME News10d
CDRH launches ‘Idea Lab’
The Center for Devices and Radiological Health (CDRH) is unveiling an Idea Lab as part of the Home as a Health Care Hub initiative to help innovators, providers and patients reimagine the ...
TMCnet12d
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 ...