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Medical Devices / Regulatory Affairs

CDRH Unveils Guidance Development List for FY 2018

Dec. 19, 2017
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Industry can get a glimpse of CDRH guidances set to be finalized, drafted or revised during fiscal year 2018 on a newly posted list on the FDA website.

Commissioner Scott Gottlieb offered some details on two of the listed draft guidances in a related FDA Voice blog.

One guidance, the Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria, will establish a new voluntary and alternative 510(k) pathway intended to provide additional flexibility.

Another guidance, the Application of Acceptable Uncertainty to Support Marketing Authorization Decisions for Medical Devices, will outline how the FDA intends to determine acceptable levels of uncertainty with submissions.

The two draft guidances will be given more priority for development during FY 2018 than some others included in the list, which is divided into guidance documents that the agency “fully intends” to issue (A-list), those that will be published “as resources permit” (B-list), and those that date back as far as 1978 and are “subject to focused retrospective review,” the FDA said.

The lists are not meant to be comprehensive, and resource constraints or other issues may prevent CDRH from being able to go down the lists in their entirety, the agency said.

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