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Industry Update: U.S. FDA Quality Management System Regulation

On March 2, 2022, the U.S. Food and Drug Administration (FDA) Device Good Manufacturing Practice Advisory Committee will meet to discuss and make recommendations on the current good manufacturing practice requirements for medical devices as part of an ongoing effort to more closely align U.S. Quality System requirements to other international standards.

ACS Releases Review of Chemical Characterization Practices for Medical Devices on Behalf of FDA

On February 17, 2022, the American Chemical Society released a publication on behalf of the U.S. Food and Drug Administration (FDA) describing the current state and opinion of the FDA regarding chemical characterization processes and ways in which to improve them. In particular, the FDA’s response is intended to examine specific topics to promote continuous discussion regarding the disparities between where the industry currently stands and how alignment and proper development may occur.