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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) is the medical regulatory body in Germany. It operates under the Federal Ministry of Health (BMG). It is headquartered in Bonn, Germany. [1] Its president is Karl Broich. [2]
The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011, the program had received more than 40,000 adverse event reports. [1]
About 10,655 devices, which were distributed between Oct. 26, 2022 and July 17, 2023, have been recalled by the company. B. Braun Medical did not immediately respond to a Reuters request for comment.
(Reuters) - The U.S. Food and Drug Administration classified a recall of Teleflex's inflatable devices that increase blood supply to the heart muscle as "most serious".
(Reuters) -The U.S. Food and Drug Administration on Thursday classified the recall of privately held Vyaire Medical's respiratory support devices as most serious and said their use could cause ...
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
The recall applies to Life2000 ventilators with the product code MS01-0118 that have the attached battery charger dongle, and were distributed in the U.S. from Aug. 21, 2023 to April 2, 2024 ...