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In Brief: Preamendment Class III device classification

This article was originally published in The Gray Sheet

Executive Summary

Preamendment Class III device classification: FDA has received data from approximately 10% of manufacturers required to submit safety and effectiveness information by the Aug. 14 deadline under the agency's August 1995 call for data on pre-1976 Class III devices per section 515(i) of the FD&C Act ("The Gray Sheet" Aug. 21, 1995, p. 6). The data, for preamendment devices for which FDA has not yet issued a call for PMAs, will be used by the agency to determine which devices will remain in Class III and which can be downclassified. FDA's Office of Device Evaluation sent a letter the week of July 29 to 98 firms registered as manufacturers of the 17 devices covered by the Aug. 14 deadline, reminding them of the impending due date. For further information, contact ODE's Melpi Jeffries at 301/594-2186...

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