1. Medtech Insight

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

 
• By Sue Darcey

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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FDA device center's annual guidance-document agenda includes 12 final and four draft guidelines on its top-priority "A list" for FY 2017.

The agency published the guidance priority list on Dec. 22. Among the draft guidances on the A-list are two that relate to the Clinical Laboratory Improvements Amendments (CLIA), one of which is a revision to FDA's 2008 CLIA waiver guidance that is required by the 21st Century Cures Act, enacted Dec. 13. The draft guidance list also includes procedural guidances for MDUFA IV implementation

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