Zdrowie i gospodarka · 06/09/2001

Medical Devices; Draft Guidance; Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." This draft guidance document was developed as a special control guidance to support the reclassification of the hip joint metal/polymer constrained cemented or uncemented prosthesis into class II. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify this device type. This draft guidance is neither final nor is it in effect at this time.