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Orthopedic Panel To Weigh Spinal Fusion, Non-Fusion Device Guidance Issues

This article was originally published in The Gray Sheet

Executive Summary

FDA is seeking input on current guidance for preclinical mechanical, debris or wear testing to evaluate new spinal fusion and non-fusion devices

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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...

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FDA is formulating regulatory requirements for evaluating the safety and efficacy of bone cement products used in vertebroplasty and kyphoplasty procedures, the agency says in 1an Oct. 31 FDA public health web notification

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