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As several PPEs, Ventilators, test kits, and other devices have been on the US market for quite some time now ...
When COVID-19 caused the Commission to delay the MDR date of application by a year (May 2021), it was advised that ...
FDA has already issued temporary policies on how it regulates PPEs and various other covid-19 essential medical ...
The EU commission released a guidance document this week that explains the commission’s policies for transitioning ...
The FDA has recently released a new emergency use authorization (EUA) template aimed at developers of at-home ...
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, was officially declared a pandemic back in early ...
Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products ...
In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the ...
Bingham Farms, MI, June 12, 2020 – E.M.M.A. International Consulting Group, Inc. (EMMA International), a ...
As medical device firms adjust to the new normal in light of COVID-19 hurdles, the FDA continues to issue ...
In an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will ...
Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all ...
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