FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More
FDA's device center 'has a lot of work ahead of us,' to implement not only the 21st Century Cures Act, but also maintain performance goals for device and drug reviews, speakers said at a Food Drug Law Institute meeting May 5. The agency released a proposed work plan for use of 'Cures' Innovation Account funds, with dollars detailed for the device side on breakthrough devices, humanitarian device exemptions, and least burdensome device provisions, among others, as spelled out for use at a May 8-9 Science Board meeting.
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'Breakthrough' Blueprint: US FDA Draft Guideline Outlines Revised Expedited Development Program
The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."
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.