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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.

The enactment this month of the 21st Century Cures Act on top of the draft MDUFA IV user-fee agreement inked between US FDA and industry this summer add a range of mandates and commitments for FDA's device center. Not least among those are guidance documents.

Guidance documents are intended to provide the bread-and-butter of what device companies need to know to get products to the US market and maintain compliance. The device center, on Dec....

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