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CDRH and the Office of Regulatory Affairs would have to “reprioritize and reevaluate” device programs under the Trump administration’s proposed budget for fiscal 2018. Read More
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure on May 15, aligning inspection staff into seven product categories — and creating three new geographic divisions for oversight of devices. Read More
FDA Commissioner Scott Gottlieb drew questions from lawmakers on device approvals as he laid out his early priorities in a House appropriations hearing Thursday, and announced that the hiring freeze on the agency had officially been lifted. Read More
China’s Food and Drug Administration received more than 350,000 medical device adverse event reports in 2016, an increase of 10 percent on the previous year. Read More