FDA proposes changes to key medical devices approval pathway

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An FDA sign — health policy coverage from STAT
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WASHINGTON — There’s about to be a new acronym in town.

The Food and Drug Administration is in the final stages of cementing sweeping changes to the Office of Regulatory Affairs, which oversees inspections and compliance for all its regulated products, according to three people familiar with the planning.

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That overhaul includes a new name: Meet the Office of Inspections and Investigations.

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