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This article was originally published in The Gray Sheet
OVERDUE 510(K) BACKLOG AT FDA DROPS TO 768 IN JULY, down from 836 submissions in June, according to FDAers. The number of 510(k)s under review at FDA's Office of Device Evaluation for more than 90 days continues to drop from the all-time high of 1,978 reached in December 1993 ("The Gray Sheet" March 7, In Brief).
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