The guidance describes the factors the @US_FDA uses to determine device type eligibility for review by Third Party Review Organizations and outlines the process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations.

The guidance describes the factors the @US_FDA uses to determine device type eligibility for review by Third Party Review Organizations and outlines the process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations.
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Devices Authors: Source Type: news
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