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Newborn Screening Tests Among FDA Classifications

 
• By Elizabeth Orr

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

Nurse performing neonatal heel-stick test
(S. Vidal/Shutterstock)

The US Food and Drug Administration has announced five more device classifications, a crucial step that allows products that reached market via the de novo process to be used as predicate devices in future 501(k) applications. The agency has been on a bit of a classification spree in the last few months, with the total number of products gaining class II status nearing two dozen.

The latest list was diagnostics-heavy, with four of the products fitting the category. Notably, two were screening tests used to...

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