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FDA CDRH Proposed 2018 Draft Guidance to Include Alternative 510(k) Pathway

By Robert Meyer

As 2017 came to a close, FDA released its annual priority list for the new year, as well as previously-issued final guidance documents for which the Center for Devices and Radiological Health (CDRH) is accepting feedback as part of its retrospective review.

Prioritized medical device guidance documents that FDA intends to publish in FY18 include an alternative pathway for manufacturers seeking 510(k) clearance.

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