We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s proposal for exempting certain IVD reagents from clinical trials.Read More
Australia’s Therapeutic Goods Administration is proposing to allow the marketing of devices that have already received marketing approval by certain overseas regulatory authorities. Read More
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