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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 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
The FDA released final recommendations for manufacturers of x-ray imaging devices aimed at clarifying the premarket review process and encouraging pediatric indications. Read More
The FDA has finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies outlining some of its initial thoughts on technical considerations. Read More
The FDA released final guidance on requirements for direct marking of devices with unique device identifiers. The final document closely resembles the draft version issued in June 2015. Read More