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CDRH Emergency Product List Update May Result From Manufacturer Survey

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers submitting comments on FDA's device shortage survey by Feb. 28 will have an opportunity to alter the agency's emergency product list

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Emergency devices

FDA submits Office of Management & Budget request March 17 to collect database information over a one-year period from 150 manufacturers of medical devices that may be used in the event of a terrorist attack. Firms wishing to comment must respond by April 16. Stakeholders had the opportunity to alter the agency's emergency device list through February (1"The Gray Sheet" Jan. 13, 2003, p. 13)...

Emergency devices

FDA submits Office of Management & Budget request March 17 to collect database information over a one-year period from 150 manufacturers of medical devices that may be used in the event of a terrorist attack. Firms wishing to comment must respond by April 16. Stakeholders had the opportunity to alter the agency's emergency device list through February (1"The Gray Sheet" Jan. 13, 2003, p. 13)...

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Developers of medical devices with possible biodefense applications will have a second opportunity to submit applications for National Institute of Allergy & Infectious Diseases biodefense partnerships after the initial NIH Jan. 24 deadline

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