[Federal Register: July 3, 2007 (Volume 72, Number 127)]
[Notices]
[Page 36470-36471]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jy07-73]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 36471]]
``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