Senate Bill Would Encourage Adverse-Event Reporting Experimentation
This article was originally published in The Gray Sheet
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.
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The Senate HELP Committee voted March 9 in favor of a breakthrough device provision, watered down from a version approved in the House last year. Other bills voted out of committee include a combination products reform measure, the digital-health focused MEDTECH Act, and four others. Senators are still debating whether NIH and FDA should get additional funds to cover the cost of the bills, which will be wrapped up into a broader package before Senate floor debate.
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.