MassDevice1d
FDA selects a CDRH official as acting commissioner
Dr. Sara Brenner, who has been FDA CDRH's in vitro diagnostics chief medical officer, is serving as acting commissioner of ...
JD Supra1d
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
Six months “a very limited window” for medical device shortage flagging
Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
medtechdive1d
FDA webpages on clinical trial diversity removed after Trump orders
The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...
Medical Design and Outsourcing5d
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
MyChesCo on MSN6mon
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 ...
FDA outlines plans to address medical device shortage risks
The FDA is particularly concerned that supply chain issues are having an adverse impact on neonatal and paediatric patients.
vator23d
The FDA outlines draft guidance on AI for medical devices
AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at ...
FierceBiotech12d
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 ...
FierceBiotech2d
FDA's diagnostics CMO named interim agency commissioner
The FDA has tapped Sara Brenner to serve as acting commissioner as it awaits new leadership from the Trump administration to ...
COBIT5mon
Design, Build and Deliver Safer Products—Faster
What is the Voluntary Improvement Program? The Case for Quality collaborative community Voluntary Improvement Program (VIP) was developed with FDA CDRH, MDIC, ISACA and the medical device industry.