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Key FDA Drug and Device Updates | Insights | Greenberg Traurig LLP

Key FDA Drug and Device Updates | Insights | Greenberg Traurig LLP
gtlaw.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from gtlaw.com Daily Mail and Mail on Sunday newspapers.

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Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions | Arent Fox

Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions | Arent Fox
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Key FDA Drug and Device Updates

Key FDA Drug and Device Updates
Wednesday, April 21, 2021
Over the past month, there have been a significant number of developments affecting FDA-regulated companies. This GT Alert provides an update on key FDA personnel changes; on final regulations governing software that are exempt from FDA-regulation as a result of the 21st Century Cures Act (Pub. L. 114-255); and on a new FDA policy related to drug facility inspections. In addition, there are other announcements regarding medical devices and the regulation of certain personal protection equipment (PPE).
Personnel at FDA
Dr. Patrizia Cavazzoni appointed director of the Center for Drug Evaluation and Research (CDER). ....

United States , Janet Woodcock , Patrizia Cavazzoni , Communications System , Department Of Health , Image Communications Device , Human Services , Us Government Accountability Office , University Of Ottawa , Century Cures Act , Drug Evaluation , Accountability Office , Federal Food , Cosmetic Act , Inspectional Observations , Cures Act , Data Processing Module , Clinical Use , Continuous Glucose Monitor Secondary Display , Automated Indirect Immunofluorescence Microscope , Software Assisted System , Medical Device Data System , Home Uterine Activity Monitor , Medical Image Storage Device , Medical Image Communications Device , Picture Archiving ,