[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Notices]
[Pages 40130-40131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11115]


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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.

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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