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FDA Expects To Draft CLIA Waiver Guidances, Finalize NGS Documents In 2017

Executive Summary

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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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.

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