Comparing FDA Medical Device Proposal With Global Rules

Law360

Maya P. Florence Michael A. Darling

Partners William McConagha, Jennifer Bragg and Maya Florence review the Food and Drug Administration's proposal to overhaul its Quality System Regulation for medical devices to align with ISO 13485, a medical device regulation established by the International Organization for Standards. If finalized, the rule would mark an important step toward global harmonization of medical device regulation.

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