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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Until EUDAMED is brought fully online, a series of performance study application/notification documents have been created to support performance study procedures with respect to the IVDR (see MDCG 2022-19). Additional details are provided with respect to the validity of certificates and “sell-off” periods.

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Health Care Is Front and Center as DeSantis and Newsom Go Mano a Mano

Kaiser Health News

From abortion to covid-19 vaccines, Newsom and DeSantis could not be further apart. DeSantis has led his state to restrict abortion and gender-affirming care and to ban covid-related mask and vaccine mandates. The Sunshine State’s covid-19 vaccine booster rate for residents age 5 and older is 12.4%.