[Federal Register Volume 69, Number 213 (Thursday, November 4, 2004)]
[Notices]
[Pages 64313-64314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24591]


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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://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