FDA gives Quest EUA for their at-home sample collection kit for COVID-19 testing; Plans to produce 500k units by end of June
FDA says it abruptly shut down Gates-backed Seattle coronavirus study for lacking EUA, institutional review board ethics approvals
Philips gets FDA 510(K) clearance for Biosensor BX100; Disposable chest patch that lets providers remotely monitor patient heart and respiratory rates
Stericycle predicts a surge in medical device recalls starting in Q3 as FDA Emergency Use Authorizations and enforcement-discretion end
FDA abruptly orders Seattle Coronavirus Assessment Network, a Gates-backed initiative to do broad coronavirus testing, to stop performing tests and reporting results pending review
FDA pulls approval for 60+ mask makers in China after discovering products don't meet safety standards
FDA grants EUA for Sherlock Biosciences' CRISPR-based coronavirus test; First CRISPR product through the FDA
FDA reverses course, will now require coronavirus antibody tests to receive emergency use authorization; Only 12 tests have been authorized so far, 250+ are pending
