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The Department of Justice announced yesterday that two Chinese hackers have been indicted on charges of trying to hack COVID-19 vaccine research in the U.S. Read More
The agency noted in new guidance that COVID-19 and other factors are creating obstacles for labelers in meeting the UDI direct mark requirements for certain finished devices already manufactured, labeled and in inventory. Read More
“The medical technology industry would strongly encourage allowing ‘virtual audits’ when necessary and consider them as a tool to overcome challenges linked to the CE marking procedure when on-site audits cannot be performed,” MedTech Europe said. Read More
The EMA commissioned the ACCESS project with Utrecht University in May to study data sources and methods that can be used for the postmarketing evaluation of COVID-19 vaccines. Read More
As a result of the COVID-19 pandemic, the FDA has extended its enforcement discretion policy for six months for manufacturers of stem cell products to submit marketing applications to the FDA. Read More