FDA Allows Remote Review of Digital Pathology Slides - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--ResearchAndMarkets.com has published a new article "FDA Allows Remote Review of Digital Pathology Slides"

The US Food and Drug Administration has temporarily relaxed regulations around digital pathology devices to facilitate remote review of scanned slide images during the pandemic. This can help to reduce pathologists risk of exposure to the virus and minimize disruptions to pathology services. Previously, pathologists were required to work from a healthcare setting that held a current CLIA license.

The FDA has also tightened requirements for antibody tests featured on the notification list of tests offered under the Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency. Companies who wish to be featured will have to submit data on their tests’ accuracy and how it will be marketed. In late May the FDA removed more than 30 tests from the notification list. Some were withdrawn voluntarily by the manufacturer while others were removed because there is no pending or issued Emergency Use Authorization. The FDA does not expect that these tests will be marketed or distributed.

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