Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in April 2021. Updated April 30.
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Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in May 2021. Updated May 13.
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FDA’s medical device inspection branch officially launched what it calls the “Remote Regulatory Assessments” program in February. Trang Cox, a device inspector at FDA, recently provided an overview of how to participate in the program and what to expect.