FDA Guidance Mulls Uncertainty In Device Reviews
New draft guidelines from US FDA offer a framework on how the agency will review device applications that include some uncertainty as to the benefits and risks of the technology.
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A new guidance document from the US agency attempts to make the process for weighing uncertainty in benefit-risk determinations more transparent and consistent.
After years of talking about how to tackle uncertainty of benefit/risk in devices under review, US FDA has released a guidance on the issue. Medtech Insight caught up with FDA device center director Jeff Shuren at a meeting in Washington, DC, to talk about the guidance and what he hopes will come of it.
The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."