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FDA to publish MRA (mutual recognition agreement) expansion proposal "within weeks"

This article was originally published in Clinica

Executive Summary

The European Commission has welcomed the US FDA's proposal to significantly expand the list of products eligible for inclusion in the EU/US mutual recognition agreement (MRA) and to include in vitro diagnostic products. European industry has generally been unenthusiastic about the trade agreement because of the small number of devices (97) included and has long been pushing for a broader scope (see Clinica No 943, p 3).

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