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  • How to Prepare for COVID-19 EUA or Enforcement Policy Expiration
    Fda | Covid-19

    How to Prepare for COVID-19 EUA or Enforcement Policy Expiration

    on 22 February 2022 | By Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)

    Since the beginning of the COVID-19 pandemic, CDRH has dealt with an unprecedented workload to ensure timely access to high quality health products that are essential to the nation’s pandemic response. Two years later, the pandemic response remains a top priority as CDRH...

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  • FDA CDRH: What will they do in 2022?
    Medical Device | United States

    FDA CDRH: What will they do in 2022?

    on 26 January 2022 | By Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)

    “It’s tough to make predictions, especially about the future.” Whether baseball Hall of Famer-slash-philosopher Yogi Berra actually said these words or not, the sentiment rings true, as anyone who has tried to predict the course of the COVID-19 pandemic would know. Predicting...

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