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FDA | COVID-19

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

By: Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)
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medical device | United States

FDA CDRH: What will they do in 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 when the Center for Devices and Radiological Health (CDRH) at the U.S. Food & Drug Administration (FDA) will return back to normal is also no exception. Just as things were starting to look up, the Omicron coronavirus variant has appeared to put another wrench in FDA’s plans. This has delayed FDA’s in-person return to the office and caused FDA to postpone non-mission critical inspections until February 2022.[1] While FDA’s COVID-19 response is still the Agency’s number one priority, there are other important changes to be aware of in 2022.
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