Last month, FDA issued a policy providing regulatory flexibility in certain circumstances for validated serological tests performed in laboratories and patient care settings. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help   …

Last month, FDA issued a policy providing regulatory flexibility in certain circumstances for validated serological tests performed in laboratories and patient care settings. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help …
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Devices Authors: Source Type: news