[Federal Register Volume 67, Number 240 (Friday, December 13, 2002)]
[Proposed Rules]
[Pages 76706-76711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. 94N-0418 and 96P-0276]


Medical Devices: Cardiovascular Devices: Reclassification of the 
Arrhythmia Detector and Alarm

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the arrhythmia detector and alarm from class III (premarket 
approval) to class II (special controls) based on new information 
regarding the device. FDA is also proposing to revise the 
identification of the arrhythmia detector and alarm to separate the 
automated external defibrillator (AED) from the identification of the 
arrhythmia detector and alarm. FDA intends to propose the 
reclassification of the AED at a later time. FDA is taking this action 
in response to petitions submitted under the Federal Food, Drug, and 
Cosmetic Act (the act), as amended by the Medical Device Amendments of 
1976 (the 1976 amendments) and the Safe

[[Page 76707]]

Medical Devices Act of 1990 (the SMDA), and the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

DATES: Submit written or electronic comments by March 13, 2003.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to: http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Carole C. Carey, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8609.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The act, as amended by the 1976 amendments (Public Law 94-295), the 
SMDA (Public Law 101-629), and FDAMA (Public Law 105-115), establishes 
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 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 preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendment 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 and until the device is 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with 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 offered 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 (510(k)) procedures, 
without submission of a premarket approval application until FDA issues 
a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    The SMDA added section 515(i) to the act. This section requires FDA 
to issue an order to manufacturers of preamendment class III devices 
and substantially equivalent postamendments devices for which no final 
regulation requiring the submission of premarket approval applications 
(PMAs) has been issued. This order requires such manufacturers to 
submit to the agency a summary of, and a citation to, any information 
known or otherwise available to them respecting such devices, including 
adverse safety and effectiveness information that has not been 
submitted under section 519 of the act (21 U.S.C. 360i). Section 519 of 
the act requires manufacturers, importers, distributors, and device 
user facilities to submit adverse event reports of certain device-
related events and reports of certain corrective actions taken. Section 
515(i) of the act also directs FDA to either revise the classification 
of the device into class I or class II or require the device to remain 
in class III and establish a schedule for the promulgation of a rule 
requiring the submission of PMAs for those devices remaining in class 
III.
    In the Federal Register of May 6, 1994 (59 FR 23731), FDA announced 
the availability of a document setting forth its strategy for 
implementing the provisions of the SMDA that require FDA to review the 
classification of preamendments class III devices. Under this plan, the 
agency divided preamendment class III devices into the following three 
groups: (1) Group 1 devices are devices that FDA believes raise 
significant questions of safety and/or effectiveness, but are no longer 
used or are in very limited use; (2) group 2 devices are devices that 
FDA believes have a high potential for being reclassified into class 
II; and group 3 devices are devices that FDA believes are currently in 
commercial distribution and are not likely candidates for 
reclassification. FDA also announced its intention to call for 
submission of PMAs for the 15 highest priority devices in group 3, and 
for all group 1 devices. The agency also announced its intention to 
issue an order under section 515(i) of the act for the remaining group 
3 devices and for all of the group 2 devices.
    In the Federal Register of August 14, 1995 (60 FR 41984 and 60 FR 
41986), FDA published two orders for certain class III devices 
requiring the submission of safety and effectiveness information in 
accordance with the preamendments class III strategy for implementing 
section 515(i) of the act. FDA published two updated orders in the 
Federal Register of June 13, 1997 (62 FR 32352 and 32355). The orders 
describe in detail the format for submitting the type of information 
required by section 515(i) of the act so that the information submitted 
would clearly support either reclassification or indicate that a device 
should be retained in class III. The orders also scheduled the required 
submissions in groups, at 6-month intervals, beginning with August 14, 
1996. The device proposed in this regulation for reclassification was 
included in group 3.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act. This section provides that FDA may, by 
rulemaking, reclassify a device based upon ``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); and 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 changes in ``medical science.''
    (See Upjohn v. Finch, supra, 422 F.2d at 951), or in light of newly 
available regulatory controls (cf. Ethicon, Inc., v. FDA, 762 F. Supp. 
382, 388-389 (D.D.C. 1991)), such as special controls or design 
controls. However, regardless of whether data before the agency are 
past or new data, the ``new information'' on which any reclassification 
is based is required to consist of ``valid scientific evidence'' as 
defined in section 513(a)(3) of the act and 21 CFR

[[Page 76708]]

860.7(c)(2). FDA relies upon ``valid scientific evidence'' in the 
classification process to determine the level of regulation for 
devices.

II. Regulatory History of the Device

    The arrhythmia detector and alarm subject to this proposal was 
classified in part 870 (21 CFR part 870) by a final rule published in 
the Federal Register of February 5, 1980 (45 FR 7907) at Sec.  
870.1025. In the proposed rule upon which the final rule was based 
(March 9, 1979 (44 FR 13284)), FDA considered the recommendations of 
the Cardiovascular Device Classification Panel. Subsequently, FDA 
classified the arrhythmia detector and alarm into class III, because 
there was insufficient information to determine that class I or class 
II controls could provide reasonable assurance of the safety and 
effectiveness of the device.
    FDA is addressing three petitions to reclassify arrhythmia 
detectors and alarms from the Health Industry Manufacturers Association 
(HIMA) (now known as Advamed); Quinton Instrument Co.; and Zymed 
Medical Instrumentation (Refs. 1 through 3) and safety and 
effectiveness information (``515(i) submissions'') submitted by 
Datascope Corp.; Hogan and Harton L.L.P.; Life Sensing Instrument Co.; 
Inc.; Medical Data Electronics; Mennen Medical Ltd.; Mortara 
Instrument; and, Olsson, Frank and Weeda, P.C. (Refs. 4 through 10).
    FDA is not addressing at this time the petitions submitted by HIMA 
(Advamed) to reclassify automated external defibrillators (AEDs) from 
class III to class II. This device is primarily designed for a 
different intended use than the arrhythmia detector and alarm. An AED 
has a shock advisory algorithm, automatically detects a shockable 
cardiac rhythm, and automatically delivers an electric shock (fully 
automated device) or delivers a shock when activated by the operator 
(semi-automated device). Defibrillators are preamendment class II 
devices under Sec.  870.5300. Arrhythmia detectors and alarms are 
preamendment class III devices under Sec.  870.1025. AEDs are devices 
found substantially equivalent to the class III arrhythmia detector and 
alarm (Sec.  870.1025) in response to a 510(k) because they are a 
combination of the class II defibrillator and the class III arrhythmia 
detector and alarm. FDA, therefore, found them equivalent to the higher 
class of the combined devices. In a future issue of the Federal 
Register, FDA will publish a notice of a panel meeting that will 
discuss the possible reclassification of AEDs.

III. Proposed Addition of Identification for AEDs

    FDA is proposing to add a new identification of the AEDs to read as 
follows:
    An automated external defibrillator is a low-energy device with 
a rhythm recognition detection system that delivers into a 50 ohm 
test load an electrical shock of a maximum of 360 joules of energy 
used for defibrillating (restoring normal heart rhythm) the atria or 
ventricles of the heart. The device analyzes the patient's 
electrocardiogram, interprets the cardiac rhythm and automatically 
delivers an electrical shock (fully automated AED), or advises the 
user to deliver the shock (semi-automated or shock advisory AED) to 
treat ventricular fibrillation or pulseless ventricular tachycardia.
    The name of the classification regulation, arrhythmia detector and 
alarm and the identification of these devices will remain unchanged.

IV. Proposed Reclassification

    FDA is proposing that the arrhythmia detector and alarm be 
reclassified from class III to class II. FDA believes that the guidance 
document identified in section VIII of this document as the special 
control would provide reasonable assurance of the safety and 
effectiveness of the device. Therefore, in accordance with sections 
513(e) and 515(i) of the act and 21 CFR 860.130, based on new 
information with respect to the device, FDA is proposing to reclassify 
the arrhythmia detector and alarm preamendment class III device into 
class II.
    The agency does not intend to exempt this proposed class II device 
from premarket notification (510(k)) submissions as permitted by 
section 510(m) of the act.
    FDA believes that it needs to review the information to address the 
risks identified in the guidance document in order to assure that a new 
device is at least as safe and effective as legally marketed devices.

V. Risks to Health

    After considering the information discussed by the panel during the 
original classification proceedings, as well as published literature, 
medical device reports (MDR), and section 515(i) of the act submissions 
of safety and effectiveness information, FDA has evaluated the risks 
associated with the arrhythmia detector and alarm. FDA now believes 
that the following are the risks to health associated with the use of 
the arrhythmia detector and alarm:

A. Misdiagnosis

    Inaccurate electrocardiogram (ECG) waveform measurement and 
analysis can lead to misdiagnosis and could result in failure-to-alarm 
in the case of life threatening arrhythmias or cause false alarms to be 
activated. Conditions exist under which an algorithm may misclassify 
portions of the ECG waveform. Inadequate design and poor signal 
processing techniques in the presence of artifact or noise can also 
result in miscounting of heart rate and misclassification of 
arrhythmias. Noise degrades signal quality and is affected by patient 
motion, electromagnetic interference, and improper electrode placement. 
It may distort the signal to the point the data are invalid or cannot 
be analyzed.
    Although the algorithm in most commercially available devices today 
has improved accuracy in both beat detection and beat classification 
with enhanced noise reduction techniques, it is extremely difficult to 
design a system that accurately analyzes 100 percent of all 
arrhythmias. Algorithm accuracy is a potential safety and effectiveness 
issue; however, it is not frequently reported as an adverse event. 
Approximately 6 percent of the MDR and complaint data are attributed to 
algorithm accuracy (Ref. 1). The ability of ST-segment measurement 
algorithm performance to predict clinical conditions has not been 
completely validated. Literature indicates that this capability is 
helpful for patients who have the potential of experiencing ischemic 
episodes and some clinicians believe changes in the ST segment can be 
indicative of myocardial ischemia (Refs. 11 through 15).
    The performance of an automated, computerized, arrhythmia monitor 
system is dependent on the accuracy of the arrhythmia detection and 
identification algorithm. If inaccurate diagnostic data are used in 
managing the patient, the physician may prescribe a course of treatment 
that places the patient at risk.

B. Incorrect Pacemaker Pulse Detection

    Many patients on ECG monitoring systems also have pacemakers. This 
condition poses a particular problem as the detection of pacemaker 
pulse artifact during ``loss of capture'' (heart does not respond to 
the pacing pulse stimulus), may inappropriately be interpreted as a 
normal beat. Failure of a heart rate alarm to occur during loss of 
capture compromises the patient's condition and may result in death. In 
the early 1990s, Emergency Care Research Institute (ECRI) investigated 
the difficulties in monitoring pacemaker patients (Ref. 16). Their 
initial testing of the patient monitors demonstrated the devices' 
limited ability to reliably reject simulated pacemaker signals. A

[[Page 76709]]

subsequent 1994 publication reported concerns about the ability of 
telemetry arrhythmia monitoring systems to accurately and reliably 
identify pacemaker pulses (Ref. 17). Another type of problem 
encountered when monitoring patients with pacemakers is a false alarm 
due to a ``no detect'' time window (a brief period when the device is 
not sensing the patient's ECG) that occurs when the monitor sees the 
pacemaker spike, but fails to see the patient's own ECG signal. 
Although the potential risk associated with pacemakers is high, the 
incidence of incorrect pacemaker pulse detection is low based on the 
relatively small number of reports. A review of manufacturers' MDRs 
between 1984 and 1995 showed that approximately 14 percent of MDRs were 
attributed to pace pulse detection capability (Ref. 1).

C. Delayed Response to Life Threatening Arrhythmias Due to User Error, 
Improper Training, and Unattended Monitors

    The level of training and quality of user training greatly affect 
the safe and effective operation of arrhythmia monitoring systems. An 
unattended monitor, or use by untrained or improperly trained clinical 
staff, can adversely affect system performance. In a system where 
excessive false alarms occur (from causes described in previous 
paragraphs), this may result in user failure to respond promptly to 
critical alarms. Furthermore, caregivers could develop a negative 
attitude from the false alarms, eroding user confidence in the device 
and resulting in deactivation of the alarm or failure to reset the 
alarm. HIMA (Advamed) indicated that approximately 15 percent (9 of 59) 
of the MDRs from 1984 to 1995 were attributed to alarm functionality 
(i.e., alarms turned off by the staff) (Ref. 1). Other device 
performance concerns are difficulty in using the device and the device 
taking too much time to use (i.e., setting up the patient and ensuring 
that the algorithm has learned the appropriate rhythms) (Ref. 18).

D. Loss of Alarm at Central Station or Bedside

    Loss of alarm at central station or bedside may occur due to 
software crash, hardware failure preventing communication, and/or the 
inability of central station to receive data/alarms from the bedside 
monitor.

E. Excessive Patient Leakage Current

    Excessive patient leakage current may result in electrically 
induced cardiac arrhythmias.

VI. Summary of the Reasons for Reclassification

    After considering the data and information contained in the 
petitions, 515(i) submissions of safety and effectiveness information, 
published literature, and over 20 years of device experience in the 
clinical environment, FDA believes that the arrhythmia detector and 
alarm can be reclassified into class II. Special controls, in addition 
to general controls, can address the risks described above and provide 
reasonable assurance of the safety and effectiveness of the device. FDA 
believes there is sufficient information to establish special controls 
to provide such assurance.

VII. Summary of Data Upon Which the Reclassification is Based

    In addition to the potential risks of the arrhythmia detector and 
alarm described in section V of this document, there is reasonable 
knowledge of the benefits of the device. Specifically, arrhythmia 
detector and alarm monitoring systems allow cardiac monitoring of 
patients who are at significant risk of immediate life-threatening 
arrhythmias, such as patients suspected of having acute myocardial 
infarction, patients who have been recently resuscitated from cardiac 
arrest, and patients with unstable angina (Ref. 19). When monitoring 
for evidence of cardiac ischemia, the ST-segment monitoring feature in 
the arrhythmia detector and alarm devices allows timely notification of 
ST- segment changes. The integrated alarm system alerts caregivers to 
any life threatening arrhythmias that require their immediate attention 
and assessment of the patient's condition before treatment 
intervention. In addition to patient cardiac monitoring in critical 
areas, it is also frequently used in noncritical settings to improve 
patient care management and serve as a labor saving device. The 
computerized documentation or trending of arrhythmia events is far more 
efficient than piecing together pages of ECG strips.
    Based on the available information, FDA believes that the special 
controls discussed in section VII of thus document are capable of 
providing reasonable assurance of the safety and effectiveness of the 
arrhythmia detector and alarm with regard to the identified risks to 
health of this device.

VIII. Proposed Special Controls

    FDA believes that the special control guidance document entitled 
``Class II Special Controls Guidance Document: Arrhythmia Detector and 
Alarm; Draft Guidance for Industry and FDA,'' in addition to general 
controls, can address the risks to health described in section V of 
this document. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of this guidance document. FDA is also 
revising Sec.  870.1 to inform the reader as to the availability of the 
guidance document.
    If adopted, following the effective date of a final rule 
classifying the device, any firm submitting a 510(k) premarket 
notification for the device would need to address the issues covered in 
the special control guidance. However, the firm would need to show only 
that its device meets the recommendations of the guidance or in some 
other way provides equivalent assurances of safety and effectiveness.
    The guidance document contains specific recommendations with regard 
to the information and testing in the premarket notification 
application. Particular sections of the guidance document address the 
following topics:
    [sbull] Safety testing (software validation, electrical safety and 
environmental handling testing, electromagnetic compatibility),
    [sbull] Performance testing, and
    [sbull] Labeling.

A. Safety Testing

    Safety testing as described in the guidance document includes 
software validation, electrical safety and environmental handling 
testing, and electromagnetic compatibility. The in vitro safety testing 
can help control the risks of incorrect pacemaker pulse detection and 
other risks associated with the use of the device, such as loss of 
alarm at central station or bedside monitor, excessive patient leakage 
current, injury to patient's skin, and electrical shock to the 
operator. Proper design can improve the paced patient algorithm 
performance. For example, the pace pulse detection should be 
implemented on the unfiltered ECG signal prior to processing of the 
waveform by the QRS beat detector. Most of the other concerns addressed 
in this section of the guidance are well known and are generic to 
microprocessor-controlled, software-driven, electromedical devices. 
This section of the guidance makes recommendations on the qualification 
testing to evaluate the device electrical safety requirements, its 
ability to function after exposure to environmental hazards, 
electromagnetic compatibility in the intended environment of use, and 
software validation based on the use of relevant

[[Page 76710]]

consensus standards and/or other FDA guidance documents.

B. Performance Testing

    The section on performance testing of the guidance document can 
help control the risks of misdiagnosis from inaccurate ECG signal 
measurement and misclassified waveforms. The availability of annotated 
arrhythmia databases has allowed detection algorithms to be tested on 
the same data. It is recommended that manufacturers properly test the 
accuracy of the automated arrhythmia detection and ST-segment 
measurement algorithms, and disclose the results of those tests. This 
section of the guidance document also emphasizes testing to demonstrate 
conformance to relevant ECG standards, testing alarm accuracy within a 
few seconds of the onset of critical life threatening arrhythmias, and 
testing other alarms functions including those related to system tasks. 
The guidance also recommends comparative testing to a legally marketed 
predicate device. If the device incorporates significant new features, 
additional testing may be necessary. These tests may be conducted in 
the laboratory and/or clinical settings.

C. Labeling

    As described in the guidance, labeling can help control the delayed 
responses to life threatening arrhythmias due to user error, improper 
training, and unattended monitors. In addition to conformance to the 
labeling regulations at 21 CFR part 801, the user (operator) manual 
should contain detailed operating instructions designed to reduce risks 
from user error with the device. Furthermore, the device should be 
operated only by persons with specific training in the use of the 
device.

IX. FDA's Tentative Findings

    FDA believes that the arrhythmia detector and alarm can be 
reclassified into class II because special controls, in addition to 
general controls, would provide reasonable assurance of the safety and 
effectiveness of the device, and there is sufficient information to 
establish special controls to provide such assurance.

X. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this proposed 
classification 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.

XI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), 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 this device from class III to 
class II will relieve all manufacturers of the device of the cost of 
complying with the premarket approval requirements in section 515 of 
the act. Manufacturers of class III arrhythmia detectors and alarms 
currently are required to submit premarket notifications. The guidance 
document reflects existing FDA practice in the review of these 
premarket notifications. FDA expects that manufacturers of cleared 
arrhythmia detectors and alarms will not have to take any additional 
action in response to this rule, if FDA finalizes this rule. This rule 
will help expedite the review process for any new manufacturers of 
these devices. Because reclassification will reduce regulatory costs 
with respect to this device, it will impose no significant economic 
impact on any small entities, and it may permit small potential 
competitors to enter the marketplace by lowering their costs. The 
agency therefore certifies that this proposed rule, if issued, will not 
have a significant economic impact on a substantial number of small 
entities. In addition, this proposed rule will not impose costs of $100 
million or more on either the private sector or state, local, and 
tribal governments in the aggregate, and therefore a summary statement 
of analysis under section 202(a) of the Unfunded Mandates Reform Act of 
1995 is not required.

XII. Submission of Comments and Proposed Dates

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written comments regarding this proposal by (see Dates). 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 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday. FDA proposes that any find regulation based on this 
proposed rule become effective 30 days after its date of publication in 
the Federal Register.

XIII. References

    The following references have been placed on display in the Dockets 
Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. HIMA (Health Industry Manufacturers Association), 
reclassification petition, Docket No. 94N-0418, vol. 1-7, 
Washington, DC, August 14, 1996.
    2. Quinton Instrument Co., reclassification petition, Docket No. 
94N-0418, vol. 1, WA, August 14, 1996.
    3. Zymed Medical Instrumentation, reclassification petition, 
Docket No. 96P-0276/CCP 1, vol. 1, CA, August 7, 1996.
    4. Datascope Corp., submission of safety and effectiveness 
information, Docket No. 94N-0418, vol. 1, NJ, October 2, 1996.
    5. Hogan and Hartson L. L. P. for Cardiac Telecom Corp., 
submission of safety and effectiveness information, Docket No. 94N-
0418, vol. 1, Washington, DC, August 14, 1996.
    6. Life Sensing Instrument Co., Inc., submission of safety and 
effectiveness information, Docket No. 94N-0418, vol. 1, TN, July 15, 
1996.
    7. Medical Data Electronics, Inc., submission of safety and 
effectiveness information, Docket No. 94N-0418, vol. 1, CA, August 
14, 1996.
    8. Mennen Medical Ltd., submission of safety and effectiveness 
information, Docket No. 94N-0418, vol. 1, October 25, 1996.
    9. Mortara Instrument, Inc., submission of safety and 
effectiveness information, Docket No. 94N-0418, vol. 1, WI, August 
14, 1996.
    10. Olsson, Frank and Weeda, P. C. for QMED, Inc., submission of 
safety and effectiveness information, Docket No. 94N-0418, vol. 1, 
Washington, DC, August 15, 1996.
    11. Ellis, J. et al., ``Comparison of Two Automated ST-Segment 
Analysis Systems, EKG (Including T Wave Inversion Analysis), and 
Transesophageal Echocardiography for the Diagnosis of Intraoperative 
Myocardial Ischemia,'' abstract (included in Ref. 1).
    12. Gottlieb, S. et al., ``Silent Ischemia on Holter Monitoring 
Predicts Mortality in High-Risk Postinfarction Patients,'' Journal 
of the American Medical Association, vol. 259, pp. 1030-1035, 1988 
(included in Ref. 1).

[[Page 76711]]

    13. Krucoff, M., ``Identification of High Risk Patients with 
Silent Myocardial Ischemia After Percutaneous Transluminal Coronary 
Angioplasty by Multilead Monitoring,'' American Journal of 
Cardiology, vol. 61, pp. 29F-24F, 1988 (included in Ref. 1).
    14. Muller, J. and Barash, P., ``Automated ST-Segment 
Monitoring,'' International Anesthesioogy Clinics, vol. 31, pp. 45-
55, 1993 (included in Ref. 1).
    15. Nademanee, K. et al., ``Characteristics and Clinical 
Significance of Silent Myocardial Ischemia in Unstable Angina,'' 
American Journal of Cardiology, vol. 58, pp. 26B-33B, 1986 (included 
in Ref. 1).
    16. ECRI, ``Physiologic Patient Monitors,'' update, Health 
Devices, vol. 21, Nos. 3-4, pp. 123-128, March-April 1992.
    17. ECRI, ``Ambulatory Telemetry Arrhythmia Monitoring Systems 
(including Guidance Section: Implementation and Effective Use of 
Telemetry Arrhythmia Monitoring Systems,'' Health Devices, vol. 23, 
No. 7, pp. 267-305, July 1994.
    18. Badura, F., ``Nurse Acceptance of a Computerized Arrhythmia 
Monitoring System,'' Instrumentation for Critical Care, vol. 9, pp. 
1044-48, 1980 (included in Ref. 1).
    19. Emergency Cardiac Care Committee of the American College of 
Cardiology, ``Recommended Guidelines for In-Hospital Cardiac 
Monitoring of Adults for Detection of Arrhythmias,'' Journal 
American of College Cardiology, vol. 18, pp. 1431-1433, 1991 
(included in Refs. 1 and 8).

List of Subjects in 21 CFR Part 870

    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 870 be amended follows:

PART 870--CARDIOVASCULAR DEVICES

    1. The authority citation for 21 CFR part 870 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 870.1 is amended by adding paragraph (e) to read as 
follows:


Sec.  870.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html.
    2. Section 870.1025 is revised to read as follows:


Sec.  870.1025  Arrhythmia detector and alarm.

    (a) Arrhythmia detector and alarm (including ST-segment measurement 
and alarm)--(1) Identification. An arrhythmia detector and alarm is 
system that monitors the electrocardiogram and is designed to produce a 
visible or audible signal or alarm when an atrial or ventricular 
arrhythmia, such as a premature contraction or ventricular 
fibrillation, exists.
    (2) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Arrhythmia Detector and Alarm; 
Guidance for Industry and FDA.'' See Sec.  870.1 for the availability 
of this guidance document.
    (b) Automated external defibrillator-- (1) Identification. An 
automated external defibrillator is a low-energy device with a rhythm 
recognition detection system that delivers into a 50 ohm test load an 
electrical shock of a maximum of 360 joules of energy used for 
defibrillating (restoring normal heart rhythm) the atria or ventricles 
of the heart. The device analyzes the patient's electrocardiogram, 
interprets the cardiac rhythm and automatically delivers an electrical 
shock (fully automated AED), or advises the user to deliver the shock 
(semi-automated or shock advisory AED) to treat ventricular 
fibrillation or pulseless ventricular tachycardia.
    (2) Classification. Class III (premarket approval).
    (3) Date PMA or notice of PDP is required. No effective date has 
been established of the requirement for premarket approval.

    Dated: October 23, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-31440 Filed 12-12-02; 8:45 am]
BILLING CODE 4160-01-S