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
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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
Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more
On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren issued a joint statement proposing to rebrand and modernize the...more
Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more
For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the FDA. ...more
Preparing for advisory panel meetings for companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the U.S. FDA. To ensure a...more