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FDA spells out new guidelines for medical device makers

from MedCity News via WRAL Tech Wire

The U.S. Food and Drug Administration issued new guidelines March 27 to help device makers understand how FDA reviewers evaluate premarket approval for high-risk devices and de novo submissions for moderate risk devices. In doing so, the agency reiterated a desire to provide clarity, consistency and transparency to a process that device manufacturers often have charged as unpredictable, capricious and confusing. more


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