[Federal Register: November 4, 2004 (Volume 69, Number 213)]
[Proposed Rules]
[Page 64266]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no04-14]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. 2000N-1409]
Medical Devices; Revision of the Identification of the
Iontophoresis Device; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; withdrawal.
-----------------------------------------------------------------------
SUMMARY: 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).
DATES: The proposed rule is withdrawn on November 4, 2004.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-827-2974.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 23, 1983 (48 FR 53032), FDA
issued a final rule classifying the iontophoresis device into class II
(performance standards before the Safe Medical Devices Act of 1990 and
now special controls) and class III (premarket approval), depending on
its intended use. An iontophoresis device is a device that is intended
to use a direct current to introduce ions of soluble salts or other
drugs into the body and induce sweating for diagnostic or other uses.
If the iontophoresis device is intended for use in the diagnosis of
cystic fibrosis or another intended use and the labeling of the drug
intended for use with the device bears adequate directions for the
device's use with that drug, the device is categorized as class II. An
iontophoresis device that is intended to introduce ions of soluble
salts or other drugs into the body for other purposes is categorized as
class III.
In the August 2000 proposed rule, FDA proposed regulations to amend
the physical medicine devices regulations to remove the class III
(premarket approval) iontophoresis device identification. FDA proposed
this action because it believed that there were no preamendments
iontophoresis devices marketed for uses other than those described in
the class II identification. FDA expected that manufacturers of those
devices currently in class III would be able to relabel their devices
to meet the class II identification.
II. Withdrawal of the Proposed Rule
FDA received substantial comment in response to the August 2000
proposed rule. Several comments disagreed with FDA's assertion that no
class III preamendments iontophoresis devices existed. In response to
these comments, FDA is considering other courses of action and is
withdrawing the August 2000 proposed rule.
III. Alternative Action
Elsewhere in this issue of the Federal Register, FDA is providing
interested persons with an opportunity to submit new information
concerning the safety and effectiveness of the iontophoresis device.
After FDA reviews any information that it receives in response to this
notice, the agency will decide whether it should go forward with a
reclassification of those iontophoresis devices currently in class III
and whether a panel meeting is necessary before taking any action.
Dated: October 25, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-24590 Filed 11-3-04; 8:45 am]
BILLING CODE 4160-01-S