[Federal Register Volume 65, Number 163 (Tuesday, August 22, 2000)]
[Proposed Rules]
[Pages 50949-50951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. 00N-1409]


Physical Medicine Devices; Revision of the Identification of the 
Ionotophoresis Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the physical medicine devices regulations to remove the class III

[[Page 50950]]

(premarket approval) iontophoresis device identification. FDA is taking 
this action because the agency believes that there were no 
preamendments iontophoresis devices marketed for uses other than those 
described in the class II identification. This action is being taken 
under the Federal Food, Drug, and Cosmetic Act (the act) as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments), the Safe 
Medical Devices Act of 1990 (the SMDA), and the FDA Modernization Act 
of 1997.

DATES: Submit written comments by November 20, 2000. See section IV of 
this document for the proposed effective date of a final rule based on 
this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Russell P. Pagano, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2196.

SUPPLEMENTARY INFORMATION:

I. Classification of Devices

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), established a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the act (21 U.S.C. 360c) established three categories (classes) of 
devices, depending on the regulatory control needed to provide 
reasonable assurance of their safety and effectiveness. The three 
categories of devices under the 1976 amendments were class I (general 
controls), class II (performance standards), and class III (premarket 
approval). The SMDA changed the class II designation to ``special 
controls.''
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendment devices 
under these procedures.
    Devices that were not in commercial distribution before May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without FDA rulemaking. Those devices remain in class III and require 
premarket approval, unless and until the device is reclassified into 
class I or II or FDA issues an order finding the device to be 
substantially equivalent, under section 513(i) of the act, to a 
predicate device that does not require premarket approval. The agency 
determines whether new devices are substantially equivalent to 
previously marketed devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807.

II. The Existing Rule

    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 SMDA 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 use. The regulation defines 
a class II iontophoresis device as a device intended for use in the 
diagnosis of cystic fibrosis or for other uses, if the labeling of the 
drug intended for use with the device bears adequate directions for the 
device's use with that drug. The regulation also states that, ``When 
used in the diagnosis of cystic fibrosis, the sweat is collected and 
its composition and weight are determined.'' Although the foregoing 
sentence is accurate, FDA is removing it from the ``Identification'' 
section of the regulation because it is unnecessary for description of 
the iontophoresis device. A class III iontophoresis device is intended 
for uses other than those specified for the class II device.
    In the Federal Register of May 6, 1994 (59 FR 23731), FDA published 
a notice that set forth the agency's strategy for implementing section 
515(i) of the act (21 U.S.C. 360e(i)) to review the classification of 
certain class III devices, and either reclassify the devices into class 
I or class II or retain them in class III. In reviewing the 
iontophoresis classification as part of this process, FDA realized that 
it made an error in its identification of the class III iontophoresis 
device when the device was classified in 1983. Specifically, there were 
no preamendments devices that met the class III identification, because 
the definition had the unintended consequence of placing into class III 
all those iontophoresis devices intended for use with a drug whose 
labeling cannot bear adequate directions for the device's use with the 
drug (i.e., a drug that had not been approved for iontophoretic 
delivery). Nevertheless, from 1977 to 1998, FDA cleared 41 510(k) 
submissions from 21 firms for devices that met the class III 
identification because they were not labeled for the diagnosis of 
cystic fibrosis or for use with a drug approved for iontophoretic 
delivery. Most of the 41 letters of substantial equivalence stated that 
these devices could not be labeled for use with a drug that had not 
been approved for iontophoretic delivery. During this same time, one 
manufacturer obtained drug approval for iontocaine; and that 
manufacturer's substantial equivalence determination for its class III 
iontophoresis device now meets the definition of the class II 
iontophoresis device because its device's labeling now bears adequate 
directions for iontophoretic delivery of iontocaine.

III. Proposed Revision of the Classification

    FDA is proposing to correct this error by revoking the class III 
identification. Any device that is not substantially equivalent to the 
class II device would be considered a postamendments device that is 
automatically classified in class III under section 513(f) of the act. 
Under section 501(f) of the act (21 U.S.C. 351(f)), a class III 
postamendments device may not be introduced into interstate commerce 
for commercial distribution, unless it has in effect an approved 
premarket approval application or a notice of completion of a product 
development protocol.
    FDA is notifying all manufacturers who market iontophoresis devices 
that have been cleared as class III 510(k)'s by letter of this proposed 
action. FDA believes that manufacturers of these iontophoresis devices 
can revise the labeling of their devices to meet the class II 
identification and submit such revised labeling to the agency, 
referencing their 510(k) number. Upon satisfactory review of this 
revised labeling, FDA will issue a revised order that will establish 
that the device is equivalent to a legally marketed predicate within 
the class II identification. A new premarket notification will not be 
necessary.
    On the effective date of a final rule based on this proposed rule, 
FDA will issue letters to those manufacturers of previously cleared 
class III iontophoresis devices who have not submitted revised labeling 
for their 510(k)'s to the agency and received a revised substantial 
equivalence order.

[[Page 50951]]

FDA's letters to those manufacturers will rescind their previously 
cleared substantial equivalence orders. At that time, the manufacturer 
may no longer place the device into commercial distribution.

IV. Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 180 days after the date of publication of the 
final rule in the Federal Register.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of this proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4). Executive Order 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). The agency believes that this proposed rule is consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. In addition, the proposed rule is not a significant 
regulatory action as defined by the Executive Order and so is not 
subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Reclassification of the device from class III into 
class II will relieve manufacturers of the cost of complying with the 
premarket approval requirements in section 515 of the act. The FDA 
analysis determined that 21 manufacturers have 41 510(k)'s that will be 
affected by this proposed rule. FDA believes that submissions for the 
class III iontophoresis device will involve only changes in device 
labeling in the existing 510(k)'s and that preparation of these changes 
will require minimal cost. FDA believes that most of these devices will 
remain on the market as class II devices. The agency believes that the 
cost of complying with the labeling requirements for each manufacturer 
will be approximately $1,000. The agency, therefore, certifies that 
this proposed rule, if issued, will not have a significant economic 
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement of anticipated costs and 
benefits before proposing any rule that may result in an expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million in any one year (adjusted annually for 
inflation). The Unfunded Mandates Reform Act does not require FDA to 
prepare a statement of costs and benefits for this rule, because the 
rule is not expected to result in any 1-year expenditure that would 
exceed $100 million adjusted for inflation.

VII. Paperwork Reduction Act of 1995

    FDA concludes that this proposed rule contains no collection of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the 
proposed rule does not contain policies that have substantial direct 
effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
the agency has concluded that the rule does not contain policies that 
have federalism implications as defined in the order and, consequently, 
a federalism summary impact statement is not required.

IX. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this proposed rule by 
November 20, 2000. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments are available for public examination 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 890

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 890 be amended to read as follows:

PART 890--PHYSICAL MEDICINE DEVICES

    1. The authority citation for 21 CFR part 890 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 890.5525 is amended by adding paragraphs (d) and (e) to 
read as follows:

Sec. 890.5525  Iontophoresis device.

* * * * *
    (d) Identification. 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 use in the diagnosis 
of cystic fibrosis or for other uses if the labeling of the drug 
intended for use with the device bears adequate directions for the 
device's use with that drug.
    (e) Classification. Class II (special controls).

    Dated: August 3, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-21251 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-01-F