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Upcoming Meetings: FDA Anesthesiology and Respiratory Therapy Devices Panel

This article was originally published in The Gray Sheet

Executive Summary

FDA Anesthesiology and Respiratory Therapy Devices Panel: Slated to convene at 11 a.m. on Sept. 20 to discuss development of a guidance document on 510(k) submissions "for continuous positive air way pressure devices for treatment of obstructive sleep apnea," according to the agency's advisory committee information line. The panel also will hear presentations on FDA's 510(k) exemption of approximately 40 anesthesiology and respiratory therapy devices ("The Gray Sheet" Jan. 22, p. 6). FDA staffers note that there has been uncertainty as to whether certain devices are covered by the exemption or should be considered accessories to Class III products. The agency also wishes to obtain input on situations in which devices may technically meet the definition for exemption but nevertheless represent novel technologies that require FDA review. The meeting will take place at FDA offices at 9200 Corporate Blvd. in Rockville, Maryland. For further information, contact FDA's Michael Bazaral at 301/443-8609...

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