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FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting...

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FDA takes action to reduce surgical mask shortage

To address the increased usage and shortages of surgical masks as a result of combatting COVID-19, on August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use...

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FDA releases enforcement policy for VTM and PBS/saline transport media during the COVID-19 pandemic

On July 21, 2020, the U.S. Food and Drug Administration (FDA) issued an immediately in effect enforcement policy guidance to help facilitate the availability of devices used in transporting ...

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FDA revises EUA guidance for mask & respirator decontamination and bioburden reduction systems

On May 26, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued an immediately in effect guidance, Recommendations for Sponsors Requesting EUAs for ...

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FDA takes significant action to reduce mask and respirator shortage

To address the increased usage and shortages of respirators as a result of combatting COVID-19, on 24 March 2020 the U.S. Food and Drug Administration (FDA) issued an Emergency Use...

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FDA temporarily postpones all domestic routine facility inspections in response to COVID-19 pandemic

On 18 March 2020, in addition to a series of responses to combat the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced that it is temporarily postponing all domestic...

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FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus...

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