100 medtech applications not processed during shutdown, FDA says

10/31/2013 | Bloomberg BNA (free content)

The government shutdown prevented the FDA's device center from processing 100 medtech applications, which include submissions for premarket approval and 510(k) clearance. As a result, the agency said all user fee-related applications filed during the 16-day shutdown will be deemed to have a receipt date of Oct. 17, the day the government went back into operation.

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Bloomberg BNA (free content)

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