The U.S. FDA has issued a draft guidance to help medical device manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program.
The U.S. FDA is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components.
Certain Philips ventilators that were recalled last year may lead to injuries or death, according to a new classification of the recall by the FDA.
The U.S. FDA has issued a draft guidance to help medical device manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program.
Olympus announces that it supports the updated safety recommendations from the U.S. FDA for bronchoscope reprocessing and single-use bronchoscopes.
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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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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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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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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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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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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.
