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Abbreviated 510(k) Template May Spark Broader Use Of Program

This article was originally published in The Gray Sheet

Executive Summary

CDRH's Office of Device Evaluation is looking to collaborate with device manufacturers to develop summary reports for abbreviated 510(k)s

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FDA News In Brief

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...

FDA News In Brief

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...

CDRH Logs 226 More 510(k)s In FY 2002; Review Times Slip Four Days

CDRH issued 134 decisions for Class III 510(k)s in FY 2002, 30 more than in FY 2001, according to preliminary counts by the device center

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