[Federal Register: July 14, 2006 (Volume 71, Number 135)]
[Notices]
[Page 40130-40131]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy06-96]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0266]
Medical Devices; Anesthesiology Devices; Neurological Devices;
Denial of Request for Change in Classification of Breathing Frequency
Monitor and Electroencephalograph
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; denial of petition.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is denying the
petitions submitted by IM Systems to reclassify the SleepCheck, the
ActiTrac, and PAM-RL devices from class II (special controls) to class
I (general controls). The agency is denying the petitions because the
petitioner failed to provide sufficient new information to establish
that general controls would provide reasonable assurance of the safety
and effectiveness of the devices.
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, 301-594-
1190.
SUPPLEMENTARY INFORMATION:
I. Classification and Reclassification of Devices Under the Medical
Devices 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 (FDAMA) (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 are class I (general controls), class
II (special controls), 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: (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 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. Postamendments devices remain in
class III and require premarket approval, unless: (1) The device 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
predicate 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, subpart E of the regulations.
Reclassification of classified preamendments devices is governed by
section 513(e) of the act. This section of the act provides that FDA
may, by rulemaking, reclassify a device 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 section
513(e) 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 ``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 the SMDA
SMDA further amended the act to change the definition of a class II
device. Under the SMDA, class II devices are those devices that 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
[[Page 40131]]
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 to 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 July 16, 1982 (47 FR 31130), FDA issued
a final rule classifying the breathing frequency monitor into class II
(Sec. 868.2375). The preamble to the proposal to classify the device
included the recommendation of the Anesthesiology Device Panel. The
Panel identified the following risks to health associated with the use
of the devices: (1) Failure of the device or alarm may cause abnormal
conditions to go undiscovered and result in serious patient injury or
death and (2) if the device does not monitor the patient's breathing
frequency accurately he/she may receive incorrect therapy.
In the Federal Register of September 4, 1979 (44 FR 51726), FDA
issued a final rule classifying the electroencephalograph into class II
(Sec. 882.1400 (21 CFR 882.1400)). The preamble to the proposal to
classify the device included the recommendation of the Neurological
Device Panel. The Panel's recommendation identified the following risks
to health associated with use of the device: (1) Misuse of the device
as a result of using untrained persons may result in improper diagnosis
and treatment; (2) misdiagnosis of the physiological symptoms could
cause a misdiagnosis and lead to improper treatment of the patient's
neurological condition; and (3) electrical shock could be associated
with current leakage of the device, making it hazardous because the
device makes a low resistance contact with the patient.
On August 18, 2004, IM Systems submitted three petitions requesting
FDA to reclassify the SleepCheck device, the ActiTrac, and PAM-RL
devices from class II to class I (Ref. 1). Under 21 CFR 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 of device.
IV. Device Description
The SleepCheck device is classified within the generic type of
device called the breathing frequency monitor (Sec. 868.2375). FDA
identifies the breathing frequency monitor as a device intended to
measure or monitor a patient's respiratory rate. The device may provide
an audible or visible alarm when the respiratory rate, averaged over
time, is outside operator settable alarm limits.
The ActiTrac and PAM-RL devices are classified within the generic
type of device called the electroencephalograph (Sec. 882.1400). FDA
identifies the electroencephalograph as a device used to measure and
record the electrical activity of the patient's brain obtained by
placing two or more electrodes on the head.
V. FDA's Decision
After reviewing both the reclassification petitions and the
petitioner's responses to our subsequent requests for information, FDA
has found that the petitions do not contain any valid scientific
evidence to support a conclusion that general controls would provide
reasonable assurance of the devices' safety and effectiveness for their
intended uses or that special controls are not necessary to provide
reasonable assurance of the safety and effectiveness of the devices.
Therefore, FDA is denying the petitions for reclassification of these
device types.
VI. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These references may
be seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday.
1. Petitions from IM Systems for the reclassification of the
SleepCheck device, PAM-RL device, and the ActiTrac device, dated
August 18, 2004.
Dated: July 5, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-11115 Filed 7-13-06; 8:45 am]
BILLING CODE 4160-01-S