The U.S. FDA has issued a draft guidance to help medical device manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program.
Tag: FDA medical device safety
Olympus announces that it supports the updated safety recommendations from the U.S. FDA for bronchoscope reprocessing and single-use bronchoscopes.Read More
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.Read More
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.Read More
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.Read More
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.Read More
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.Read More