21st Century Cures: Select Device Provisions
This article was originally published in The Gray Sheet
A run-down of key provisions impacting the medical device and diagnostics industry in the 21st Century Cures legislation, which passed the House by a 344-77 vote July 10.
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The new Improving Medical Device Innovation Act contains device provisions paralleling the House 21st Century Cures Act to make it easier for FDA to recognize consensus device standards, reform the advisory panel process and encourage more 510(k) exemptions. It also includes a new proposal that would trigger pilot projects for alternative approaches to adverse-event reporting.
Medical device makers are concerned about a lack of globally harmonized standards for good clinical practices, which they say could cause problems for a guidance FDA has drafted on studies conducted outside the U.S.
A Senate bill would streamline device/drug combination registrations by letting FDA rely on prior PMAs and approved drug findings to help support new product approvals, among other reforms. It was introduced by Sen. Johnny Isakson, R-Ga., and co-sponsored by Sens. Robert Casey, D-Pa., and Pat Roberts, R-Kansas.