Department of Health and Human Services January 17, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies'' dated December 2006. The draft guidance document provides recommendations that would allow the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated, allogeneic placental/umbilical cord blood, for specified indications. The document also contains information about the manufacture of minimally manipulated, unrelated, allogeneic placental/ umbilical cord blood and how to comply with applicable regulatory requirements.

The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Orthopaedic and Rehabilitation Devices Panel to deny a petition to reclassify the non-invasive bone growth stimulator from class III to class II. The Panel made this recommendation after reviewing the reclassification petition submitted by RS Medical Corp., as well as consideration of presentations made at the Panel meeting by the petitioner, FDA, and members of the public. FDA is also issuing for public comment its findings on the Panel's recommendation. After considering any public comments on the Panel's recommendation and FDA's 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.