Advisories archive

US FDA implements online portal for production reporting

The US Food & Drug Administration (FDA or Agency) recently announced a new online portal for reporting the...
Medical devices December 08, 2021

US FDA announces withdrawal of 3 temporary guidance documents established during COVID-19 for alcohol-based products

The US Food & Drug Administration (FDA) recently issued a notice in the federal register (Docket No...
Medical devices November 15, 2021

US FDA discusses impact of COVID-19 pandemic on CDRH and how it is prioritizing workload moving forward

US FDA has issued a review A Year into the Pandemic: How the FDA’s Center for Devices and Radiological Health is...
Medical devices May 01, 2021

US FDA halts implementation of Over-The-Counter Monograph User Fee Program (OMUFA) for 2021

On December 29, the U.S. Food and Drug Administration (FDA) announced the 2021 rates for over-the-counter (OTC)...
Medical devices January 13, 2021
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