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The firm’s device history records for its recalled lots did not include the final quantity of products reviewed, approved and released for distribution. Read More
“If we can’t work everything out, that’s fine. Let’s just put pen to paper on what we have worked out and maybe enter part of the puzzle,” said Shuren. Read More
The FDA’s regulatory process for manufacturers of new moderate-risk devices has “remained largely unchanged since it was first implemented 40 years ago,” Commissioner Scott Gottlieb said. Read More
The recent ransomware attacks in the U.S. healthcare industry have highlighted the need for increased product security for medical devices, the American Hospital Association said in a letter to the FDA. Read More
The number of investigational device exemptions submitted under CDRH’s Early Feasibility Study Program has more than doubled, with 57 submitted in FY 2017 up from 26 when the agency issued EFS guidance in 2013. Read More