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FDA expects smoother registration process

This article was originally published in The Gray Sheet

Executive Summary

After sending out 15,000 letters to device manufacturers thought to be non-compliant with facility registration required under the FDA Amendments Act, CDRH has converted approximately 13,700 to "inactive" status, the agency says. Ruling out a large number of those facilities has freed up the device center to communicate with firms that should be registering and focus on ensuring compliance as the FY 2009 registration fee period approaches. FDAAA, signed into law last fall, requires every device firm regulated by FDA to register electronically (unless given a waiver to use paper) and to pay an annual registration fee by Dec. 31 (1"The Gray Sheet" Oct. 1, 2007, p. 6)
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