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FDA News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Abbreviated 510(k) project update: The Centers for Devices & Radiological Health is looking to finish, in the first quarter of 2003, collaborations with several manufacturers to draft abbreviated 510(k) summary reports, staffers say. An invitation to work with CDRH to create example summary reports serving as templates was extended to abbreviated 510(k) sponsors by the device center in June (1"The Gray Sheet" June 3, 2002, p. 3). Although CDRH has had inquiries from a number of manufacturers, not all have been fruitful, according to staffers, who are still searching for additional manufacturers with whom to collaborate on the initiative. The project is open to devices with Class II special controls final guidance documents...

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