[Federal Register: November 4, 2004 (Volume 69, Number 213)]
[Notices]
[Page 64313-64314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no04-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000N-1409]
Medical Devices; Reclassification of the Iontophoresis Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of intent.
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SUMMARY: The Food and Drug Administration (FDA) announces an
opportunity to submit information and comments concerning FDA's intent
to initiate a proceeding to reclassify those iontophoresis devices
currently in class III (premarket approval) into class II (special
controls). 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. Elsewhere in
this issue of the Federal Register, 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).
DATES: Submit written or electronic comments by February 2, 2005.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
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
[[Page 64314]]
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 Federal Register of August 22, 2000, FDA proposed 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.
In response to the August 2000 proposed rule, FDA received seven
comments. Several comments disagreed with FDA's assertion that no class
III preamendments iontophoresis devices existed. Two comments were
confused as to whether the requirement that a drug used with an
iontophoresis device bear adequate directions for use with that
specific device applies to the diagnosis of cystic fibrosis or applies
only to other uses. Two comments asserted that the assumption that
there are differences in iontophoresis devices that would warrant
linking a particular device to a particular drug is in error, and
suggested that FDA should consider reclassification of iontophoresis
devices into either class I or class II as drug delivery systems
comparable to syringes and pumps. In contrast, another comment rejected
what it perceived as the implication that all iontophoresis drug
delivery systems were the same and that any iontophoresis device could
be relabeled to reference any drug approved for iontophoretic
administration, whether or not the drug had actually been tested for
use with that particular device.
FDA is issuing this document to provide interested persons with an
opportunity to submit any new information concerning the safety and
effectiveness of the iontophoresis device. After FDA reviews any
information that the agency receives in response to this document, FDA
will decide whether the agency should go forward with the
reclassification of those iontophoresis devices currently in class III
and whether a panel meeting is necessary before taking any action.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Any received information may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 25, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-24591 Filed 11-3-04; 8:45 am]
BILLING CODE 4160-01-S