Pathways’ Picks September 16: FDA’s Post-COVID Planning, New Notified Body, and More

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ARTICLE SUMMARY:

In this week’s roundup: CDRH Post-COVID transition planning draft guidance is in the works, Pre-Subs are suffering, Slovakia has its first MDR notified body, Brazil seeks feedback on plans for new software rules, and more.

FDA’s device center is preparing a draft guidance on its plan for eventually transitioning regulatory operations away from a COVID-19 emergency footing, even as officials stress that responding to the pandemic will remain the agency’s top priority for the foreseeable future. That and more FDA updates lead off this week’s Pathways’ Picks. Also: a global news roundup.

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