The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket notifications for medical devices other than...more
On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."
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On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more
Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more
1/25/2019
/ 510(k) RTA ,
FDA Approval ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Standard of Review ,
Trump Administration ,
US-Mexico Border Wall
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
12/28/2018
/ Center for Drug Evaluation and Research (CDER) ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Trump Administration