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News from the FDA

BY ALM Staff
December 01, 2003

Premarket Approval for Three Class III Preamendments Devices

The FDA wants to require filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. In addition, requests can now be made to the agency to change the classification of any of the devices based on new information. Submit written comments or requests for a change in classification to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. For further information, go to: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-28741.htm.

McClellan Lauds Passage of Animal Drug User Fee Bill

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