FDA Expects To Draft CLIA Waiver Guidances, Finalize NGS Documents In 2017
US FDA's device center has issued its annual "A" and "B" list of guidance documents that it expects to release in FY 2017. The agency acknowledges guidance development will be needed to implement the next round of user fees (MDUFA IV), but also specifies a range of other specific guidelines it plans to prioritize not tied to user-fee commitments or statutory requirements addressing cybersecurity, medical device accessories and next-generation sequencing, among other issues.
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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.
Must-Do Guidance Development: What's On Tap From Cures, MDUFA IV
US FDA's device center is facing new mandates and commitments to develop guidelines for industry. The guidance-development stipulations in the 21st Century Cures Act and the recent MDUFA IV user-fee agreement are detailed below.