Obstetrics and Gynecology Devices; Reclassification of Home Uterine Activity Monitor

Zusammenfassung

The Food and Drug Administration (FDA) is announcing for public comment the recommendation of the Obstetrics and Gynecology Devices Panel (the Panel) to reclassify the home uterine activity monitor (HUAM) from class III to class II. The Panel made this recommendation after reviewing the reclassification petition submitted by Corometrics Medical Systems, Inc., and other publicly available information. FDA also is announcing for public comment its tentative findings on the Panel's recommendation. After considering any public comments on the Panel's recommendation and FDA's tentative findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that provides 510(k) applicants with specific directions regarding data and information that should be submitted to FDA in 510(k) submissions for HUAM's.