21st Century Cures: Device Provisions
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.
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.
FDA took the unusual step of issuing a second round of draft guidance documents in its effort to refine requirements for diagnostics companies seeking a CLIA waiver to allow point-of-care use of a test. The revised drafts are simplified compared to November 2017 versions, and they appear to line up more closely with industry arguments about what is needed to demonstrate "accuracy" in this context.