21st Century Cures Implementation: Device Provision Updates
Dozens of reforms impacting the medtech sector were signed into law Dec. 13, 2016, in the 21st Century Cures Act. Here's a breakdown of where things stand in the implementation of key provisions.
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The current administration would use an additional $98m in congressional budget authority in the 2020 fiscal year for FDA’s medical device efforts to modernize its regulatory approach for technology development, to enable device safety issues to be monitored more closely, and to advance new approaches for regulating digital health technologies and breakthrough devices.
The framework includes two draft guidance documents and two final guidances. One of the drafts, which focuses on the regulation of devices used with regenerative medicine, implements a provision of the 21st Century Cures Act and strongly suggests that most of these products will be regulated via class II.
AdvaMed CEO Scott Whitaker says Alex Azar, who is reportedly the top candidate to be nominee for US Health and Human Services secretary, would be ideal for the job with his extensive experience at the department.