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Rulemaking to Address Safety Issues for Currently Marketed Devices
Apr 19, 2016 | The National Law Review

...FDA also has issued multiple reclassification actions this quarter, including its reclassification of transvaginal surgical mesh devices from Class II to Class III in January. This device has long been the subject of safety concerns, such as severe pelvic pain, bleeding, and infection, and has resulted in multiple lawsuits against device manufacturers.

Rulemaking to Address Safety Issues for Currently Marketed Devices

Apr 19, 2016 | The National Law Review

FDA made headlines in March after it issued a proposed rule to ban powdered surgeons’ and patient examination gloves, marking only the second time ever that FDA has invoked its authority under the Federal Food, Drug, and Cosmetic Act to ban a device. FDA determined that the risks presented by these powdered gloves, including acute severe airway inflammation due to absorbable dusting powder inhalation, were unreasonable given that suitable alternatives are readily available in the current market. FDA also has issued multiple reclassification actions this quarter, including its reclassification of transvaginal surgical mesh devices from Class II to Class III in January. This device has long been the subject of safety concerns, such as severe pelvic pain, bleeding, and infection, and has resulted in multiple lawsuits against device manufacturers.

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