FDA issues cybersecurity risk alert over Contec patient monitor
The FDA says the cybersecurity vulnerabilities identified may put patients at risk when the device is connected to the ...
JD Supra3d
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 ...
medtechdive3d
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 ...
MassDevice3d
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 the agency.
Medical Design and Outsourcing7d
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 ...
Orthopedics This Week7d
New Study Tackles Poorly Designed FDA Studies
“The FDA has made a commitment to advancing health equity as part of the CDRH 2022-2025 Strategic Priorities, including ...
JD Supra7d
Gauging the Likelihood of Trump Administration FDA Reforms
Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...
medtechintelligence9d
Public Health Impact of Medical Device Supply Chain Vulnerabilities
The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent ...
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.
PharmiWeb11d
De Novo Request Helps Bring Low and Medium Risk Devices to Market
De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low ...
FierceBiotech14d
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 ...