Draft Guidance for Infant/Child Apnea Monitor 510(k) Submissions; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Guidance for Infant/Child Apnea Monitor 510(k) Submissions." This guidance is not final nor is it in effect at this time. This draft guidance describes minimum performance, testing, labeling, and clinical criteria for the infant/ child monitor. Upon considering comments on the draft document, FDA will modify the guidance so that it is applicable to apnea monitors for patients of all ages. Elsewhere in this issue of the Federal Register, FDA is proposing to classify the apnea monitor into class II with this guidance document as the special control. FDA is issuing this draft guidance because the agency believes it is necessary to provide reasonable assurance of the safety and effectiveness of the apnea monitor.