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Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

Next-generation sequencing, or NGS, has been touted as a potential game-changer in health care, but it is still in early stages and not many NGS products have passed through FDA yet. But, even with its limited experience, the agency has noticed some repeat issues in NGS submissions that it hopes future sponsors can learn from.

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