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US FDA and CMS to carry out parallel review of devices

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration and the Centers for Medicare and Medicaid Services (CMS) are planning to establish a programme that would allow medical device companies to voluntarily apply for a joint evaluation of their products by the two agencies1. Once the modalities of the programme are finalised, the agencies intend to launch a pilot under which they will jointly review a small number of innovative devices.

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