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T00-45                                     Sharon Snider: 301-827-6242
September 21, 2000                         
                                           Consumer Inquiries:888-INFO-FDA

FDA PROPOSES NEW GUIDANCE FOR APNEA MONITORS

FDA is withdrawing a proposed rule published in 1995 to establish a mandatory performance standard for infant apnea monitors because it believes such a performance standard is no longer warranted.

Since the performance standard was first proposed, a number of changes have occurred which caused the FDA to take another look at the type of regulation needed for these products: The technology of the monitors has improved; fewer deaths or serious injuries of children have been reported; and alternative international consensus standards embodying the latest scientific advances for the products have been adopted.

FDA believes that the safety and effectiveness of these devices to monitor infant and child breathing may better be assured through an agency guidance for manufacturers which describes the type of testing, performance and labeling that should be included in pre-market submissions for these products.

Both the withdrawal and the proposed guidance will be published tomorrow in the Federal Register. They will also available on FDA's web site at: http://www.fda.gov/ohrms/dockets/.

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