US class II risk for PE (Perkin Elmer) newborn test:
This article was originally published in Clinica
The US FDA has finalised plans to classify a newborn screening test manufactured by Perkin Elmer (PE) as a class II (medium-risk) device. The company petitioned for a change in classification for its NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit after the agency concluded that the test was a de novo device with no predicate, requiring the initial class III (high-risk) category. The product can now be cleared via the 510(k) process provided it meets the guidance document requirements on validation of performance characteristics and labelling developed by the agency, the FDA said.
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