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Home » SCOPE OF REPROCESSED SUDs REQUIRING VALIDATION EXPANDED
SCOPE OF REPROCESSED SUDs REQUIRING VALIDATION EXPANDED
April 16, 2004
The FDA has added three new single-use devices (SUDs) to the list of reprocessed SUDs requiring premarket clearance, a move that will force reprocessors of these devices to submit 510(k) clearance data by July 13, 2005, to continue marketing their products.