Medical Devices; Revision of the Identification of the Iontophoresis Device; Withdrawal

Streszczenie

The Food and Drug Administration (FDA) is withdrawing the proposed rule the agency issued in the Federal Register of August 22, 2000 (65 FR 50949) (the August 2000 proposed rule). In that document, FDA proposed to amend the physical medicine devices regulations to remove the class III (premarket approval) iontophoresis device identification. In response to the comments received on the proposed rule, FDA is withdrawing the proposed rule and considering and other courses of action. Elsewhere in this issue of the Federal Register, FDA is announcing an opportunity to submit information and comments concerning FDA's intent to initiate a proceeding to reclassify those iontophoresis devices currently in class III into class II (special controls).