[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Notices]
[Pages 36470-36471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005P-0213]


Neurological Devices; Denial of Request for Change in 
Classification of Cutaneous Electrode

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; denial of petition.

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SUMMARY: The Food and Drug Administration (FDA) is denying the petition 
submitted by Scientific Laboratory Products LTD., to reclassify 
electroencephalogram (EEG) electrodes from class II to class I. The 
agency is denying the petition because the Scientific Laboratory 
Products LTD., failed to provide sufficient new information to 
establish that general controls would provide reasonable assurance of 
the safety and effectiveness of the devices. This document also 
summarizes the basis for the agency's decision.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-
4021.

SUPPLEMENTARY INFORMATION:

I. Classification and Reclassification of Devices Under the Medical 
Device Amendments of 1976 (the 1976 Amendments)

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the 1976 amendments (Public Law 94-295), the 
Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-629), and the 
Food and Drug Administration Modernization Act of 1997 (Public Law 105-
115) 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 controls 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).
    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 done the following: (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 type; and (3) 
published a final regulation classifying the device type. FDA has 
classified most preamendments devices under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless: (1) The device type is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with section 513(f)(2) of 
the act; or (3) 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 of the regulations.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act (21 U.S.C. 360c(e)). This section of the act 
provides that FDA may, by rulemaking, reclassify a device (in a 
proceeding that parallels the initial classification proceeding) based 
on ``new information.'' The reclassification can be initiated by FDA or 
by the petition of an interested person. The term ``new information,'' 
as used in sections 513(e) and 515(b)(2)(A)(iv) of the act, includes 
information developed as a result of a reevaluation of the data before 
the agency when the device was originally classified, as well as 
information not presented, not available, or not developed at that 
time. (See, e.g., Holland Rantos v. United States Department of Health, 
Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); 
Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 
F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical 
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) Regardless of 
whether data before the agency are past or new data, the ``new 
information'' upon which reclassification under section 513(e) of the 
act is based must consist of ``valid scientific evidence,'' as defined 
in section 513(a)(3) of the act and Sec.  860.7(c)(2) (21 CFR 
860.7(c)(2)). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 
(D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), 
cert. denied, 474 U.S. 1062 (1985)). In addition, Sec.  860.123(a)(6) 
(21 CFR 860.123(a)(6)) provides that a reclassification petition must 
include a ``full statement of the reasons, together with supporting 
data satisfying the requirements of Sec.  860.7, why the device should 
not be classified into its present classification, and how the proposed 
classification will provide reasonable assurance of the safety and 
effectiveness of the device.'' (Sec.  860.123(a)(6).) The

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``supporting data satisfying the requirements of Sec.  860.7'' referred 
to is ``valid scientific evidence.''
    For the purpose of reclassification, the valid scientific evidence 
upon which the agency relies must be publicly available. Publicly 
available information excludes trade secret and/or confidential 
commercial information, e.g., the contents of a pending PMA. (See 
section 520(c) of the act (21 U.S.C. 360j(c).)

II. Reclassification under SMDA

    SMDA further amended the act to change the definition of a class II 
device. Under SMDA, class II devices are those devices which cannot be 
classified into class I because general controls by themselves are not 
sufficient to provide reasonable assurance of safety and effectiveness, 
but for which there is sufficient information to establish special 
controls to provide such assurance, including performance standards, 
postmarket surveillance, patient registries, development and 
dissemination of guidelines, recommendations, and other appropriate 
actions the agency deems necessary (section 513(a)(1)(B) of the act). 
Thus, the definition of a class II device was changed from 
``performance standards'' to ``special controls.'' In order for a 
device to be reclassified from class II into class I, the agency must 
determine that special controls are not necessary to provide reasonable 
assurance of its safety and effectiveness.

III. Background

    In the Federal Register of September 4, 1979 (44 FR 51732), FDA 
issued a final rule classifying the cutaneous electrode into class II 
(21 CFR 882.1320). The preamble to the proposal to classify the device 
included the recommendation of the Neurological Device Classification 
Panel (the Panel). The Panel's recommendation, among other things, 
identified the following risks to health associated with the use of the 
device: (1) Burns, since poor design or incorrect application of the 
electrodes could result in skin burns when the device is used to apply 
stimulation and (2) toxic reactions, since materials or substances in 
the electrodes that are in contact with the skin could produce adverse 
reactions.
    The panel recommended that cutaneous electrodes be classified as 
class II because the electrical properties of the device must be 
controlled to assure that, when physiological signals are recorded, 
they are adequately reproduced. If inaccurate diagnostic data are used 
in managing the patient, the physician may prescribe a course of 
treatment that places the patient at risk unnecessarily. Additionally, 
the panel recommended Class II to assure that only materials with known 
and acceptable properties are used in electrodes.
    On May 31, 2005, FDA received a petition requesting that FDA 
reclassify electroencephalogram electrodes from class II to class I 
(Ref. 1). Under Sec.  860.120(b) (21 CFR 860.120(b)), the 
reclassification of any device within a generic type of devices causes 
the reclassification of all substantially equivalent devices within 
that generic type of device.

IV. Device Description

    The electroencephalogram electrode device is classified within the 
generic type of device cutaneous electrode (21 CFR 882.1320). FDA 
identifies cutaneous electrode as an electrode that is applied directly 
to a patient's skin either to record physiological signals (e.g., the 
electroencephalogram) or to apply electrical stimulation.

V. FDA's Decision

    After reviewing the reclassification petition, FDA has found that 
the petition contains insufficient valid scientific evidence to allow 
FDA to determine that general controls would provide reasonable 
assurance of the device's safety and effectiveness for its intended 
use. FDA, therefore, is denying the petition.

VI. Reasons for the Denial

    FDA has determined that Scientific Laboratory Products LTD., has 
not presented sufficient new scientific information to support the 
requested change in classification of this device. According to Sec.  
860.120(b), the reclassification of any device within a generic type of 
device causes the reclassification of all substantially equivalent 
devices within that generic type. Accordingly, a petition for the 
reclassification of a specific device will be considered a petition for 
reclassification of all substantially equivalent devices within the 
same generic type. The petitioner has not provided any evidence to 
reclassify their own device or the generic cutaneous electrode device 
category.
    FDA believes that the petition lacks sufficient valid scientific 
evidence to allow the agency to determine that general controls would 
provide reasonable assurance of the safety and effectiveness of the 
cutaneous electrode for its intended use. Therefore, the cutaneous 
electrode shall be retained in class II.

VII. References

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Scientific Laboratory Products LTD., for the 
reclassification of the electroencephalogram electrode device, dated 
May 16, 2005.

    Dated: June 25, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-12882 Filed 7-2-07; 8:45 am]
BILLING CODE 4160-01-S