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Home » Device Classification

Device Classification

United States
U.S. FDA Clamps Down on MoM Hips, Proposes Highest Risk Classification
U.S. FDA Has No ‘Inherent Authority’ to Reclassify, Appeals Court Rules

Australia
Australia Updates List of Allowable Variants in Joint Reclassifications
TGA Offers Checklist, Tips on Joint Class III Reclassification Submissions

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