EPA: Chemical in Medical-Device Cleanser Poses Cancer Risk
The U.S. EPA is alerting residents who reside near certain commercial sterilizing plants of the health risks EtO emissions can cause.
Tag: FDA medical device safety
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Certain Karl Storz Urological Endoscopes Have Changed Reprocessing Methods, Says FDA
The FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are being updated.
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FDA’s Health of Women Strategic Plan to Better Inform Medical Device Research, Regulation
The plan seeks to strengthen regulatory science and identify current and emerging issues in medical device research and regulation for women's health.
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EPA: Chemical in Medical-Device Cleanser Poses Cancer Risk
The U.S. EPA is alerting residents who reside near certain commercial sterilizing plants of the health risks EtO emissions can cause.
FDA Wants to Require Timely Updates, Patches for Legacy Devices: Cyber Chief
The U.S. FDA’s first medical device cyber chief Kevin Fu shares with MedTech Dive his take on medical device cybersecurity and how the agency’s regulatory policy can help improve it.
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FDA Issues Updated Recommendations for Bronchoscope Reprocessing
The U.S. FDA has issued a safety communication providing new recommendations for bronchoscope reprocessing and other new information about bronchoscope medical device adverse event reports.
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Why Courts Should Bring Back Evidence of FDA Clearance in Medical Device Trials
Not allowing medical device companies to present information about the FDA’s analysis of their products in product liability cases against them results in unfair court trials, posits an article by Reuters.
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FDA: Stop New Implants of Medtronic Ventricular Assist Device System
The U.S. FDA is alerting healthcare providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device System due to safety concerns.
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FDA Seeks 8% Budget Boost for CDRH to Back Resurgence of Domestic Device Production
The U.S. FDA is proposing an increased Center for Devices and Radiological Health budget that would focus on fixing shortages and supply chain issues, reports MedTech Dive.
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FDA Issues Draft Guidances for Medical Device Studies after FDA Approval, Clearance
The U.S. FDA has issued guidance documents to help increase transparency and assist reporting and timely completion of studies on certain medical devices’ safety and effectiveness.
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Ransomware, Other Cyber Threats Mount as Medtech Industry Tries to Adapt
The U.S. FDA’s Kevin Fu is concerned about the increasing number and growing sophistication of cyberattacks on healthcare organizations, particularly their effect on medical devices and patient safety, reports MedTech Dive.
