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21st Century Cures: Device Provisions

Executive Summary

Dozens of reforms impacting the medtech sector were signed into law Dec. 13 as part of the 21st Century Cures Act. Here's a breakdown of the provisions most important to device- and diagnostic-makers.

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The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.

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Manufacturers will no longer need to submit 510(k)s for 10 unclassified device types that range from speech training aids to temperature discrimination tests.

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