Device Standards Provision In Cures Bill Could Speed Up 510(k) Clearances
Under a provision in the 21st Century Cures bill, which is accelerating towards enactment, FDA may need to consider recognizing more standards, which could speed up review times for 510(k)s. But it is also likely to add a burden for the agency.
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US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
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.
US FDA Seeks Input On Standing Up Conformity Assessment Pilot
In the latest user-fee agreement, FDA and industry agreed to pilot a conformity assessment program where third-party accredited test labs could affirm a manufacturer's conformance to consensus standards, potentially expediting pre-market reviews.