Medical Devices; Performance Standard for the Infant Apnea Monitor; Withdrawal Notice

Zusammenfassung

The Food and Drug Administration (FDA) is withdrawing the proposed rule it issued on February 21, 1995 (60 FR 9762). The document set out proposed requirements for a mandatory performance standard for the infant apnea monitor. In light of declining births and reduced mortality rates for infants at risk for death due to apparent life- threatening events (ALTE's), including certain apneas, and after considering other factors, FDA no longer believes that a mandatory performance standard is needed for this class II device. The agency believes that FDA guidance to industry that identifies minimum performance, testing, and labeling recommendations will provide reasonable assurance of the safety and effectiveness of the apnea monitor, including infant/child monitors. FDA is making this draft guidance available for comment through a notice published elsewhere in this issue of the Federal Register. Also, elsewhere in this issue of the Federal Register, FDA is proposing to create a separate classification for the apnea monitor, with the FDA guidance document as the special control.