Following seven serious injuries and one reported death, the US Food and Drug Administration (FDA) announced a Class I recall, the most serious type of recall, of some of Ethicon’s Flex Endopath surgical staplers because they may contain an out of specification component within the jaw of the device that could lead to malformed staples.
Please find below an interesting article by Morgan Lewis on the impact of Brexit on medical device regulation in the United Kingdom in JD Supra.
The U.S. Environmental Protection Agency (EPA) has issued an updated version of its energy efficiency requirements for luminaires under the Agency’s ENERGY STAR® program.
The European Commission has delayed the introduction of the medical device and in vitro diagnostics registration database until May 2022.
Mazda Australia has issued a recall for 35,476 diesel versions of its Mazda 3, Mazda 6 and CX-5 model lines over concerns build-up of carbon deposits could cause premature wear of certain engine components.