[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Rules and Regulations]               
[Page 61342-61344]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 870

[Docket Nos. 1994N-0418 and 1996P-0276]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.


SUMMARY: The Food and Drug Administration (FDA) is reclassifying 
arrhythmia detector and alarm devices from class III to class II 
(special controls). This device is used to monitor an electrocardiogram 
(ECG) and to produce a visible or audible signal or alarm when an 
atrial or ventricular arrhythmia occurs. An atrial or ventricular 
arrhythmia occurs during a premature contraction or ventricular 
fibrillation. FDA is reclassifying this device based on new information 
contained in reclassification petitions regarding the device submitted 
by the Health Industry Manufacturers Association (HIMA) (now known as 
Advamed), Quinton Instrument Co., and Zymed Medical Instrumentation. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of the guidance document that will serve as the special 
control for this device. FDA is taking this action under the Federal 
Food, Drug, and Cosmetic Act (the act), as amended by the Medical 
Device Amendments of 1976 (the 1976 amendments), the Safe Medical 
Devices Act of 1990 (the SMDA), the Food and Drug Administration 
Modernization Act of 1997 (the FDAMA), and the Medical Device User Fee 
and Modernization Act of 2002 (MDUFMA).

DATES: This rule is effective November 28, 2003.

FOR FURTHER INFORMATION CONTACT: Elias Mallis, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8517, ext. 177.


I. Background

    The act (21 U.S.C. 301 et. seq.) established a comprehensive system 
for the regulation of medical devices intended for human use. Section 
513 of the act (21 U.S.C. 360(e)) established three categories 
(classes) of devices as a function of 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, FDA refers to devices that were in 
commercial distribution before May 28, 1976 (the date of enactment of 
the 1976 amendments), as ``preamendments devices.'' FDA classifies 
these devices after the agency initiates the following procedures: (1) 
Receives a recommendation from a device classification panel (an FDA 
advisory committee), (2) publishes the panel's recommendation for 
comment, along with a proposed regulation classifying the device, and 
(3) publishes a final regulation classifying the device. FDA has 
classified most preamendments devices under these procedures.
    FDA refers to devices that were not in commercial distribution 
before May 28, 1976, as ``postamendments devices.'' These 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 FDA initiates the 
following procedures: (1) Reclassifies the device into class I or II, 
(2) issues an order classifying the device into class I or II in 
accordance with section 513(f)(2) of the act, or (3) issues, under 
section 513(i) of the act, an order finding the device as substantially 
equivalent to a predicate device that does not require premarket 
approval. As delineated in section 510(k) of the act (21 U.S.C. 360(k)) 
and under part 870 of the regulations (21 CFR part 870), FDA determines 
whether new devices are substantially equivalent to previously offered 
devices by means of premarket notification procedures. Through 
premarket notification procedures, a person may, without submission of 
a premarket approval application (PMA), market a preamendments device 
that has been classified into class III until FDA issues a final 
regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Section 513(e) of the act governs reclassification of classified 
preamendments devices. This section provides that FDA may, by 
rulemaking, reclassify a device based on ``new information.'' Under 
section 513(e) of the act, FDA can initiate a reclassification or an 
interested person can petition FDA to reclassify a preamendments 
device. The term ``new information,'' as used in section 513(e) of the 
act, includes information developed after the date of the device's 
original classification. This information could include a reevaluation 
of the original data or information from the time of the original 
classification that was not presented, available, or deemed applicable. 
(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 used by FDA 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, 389-391 
(D.D.C. 1991)), or in light of changes in ``medical science.'' (See 
Upjohn v. Finch, supra, 422 F.2d at 951.) Whether data before the FDA 
are past or new data, the ``new information'' to support 
reclassification under section 513(e) of the act must be ``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)).
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. When 
reclassifying a device, FDA can only consider valid scientific evidence 
that is publicly available. Publicly available information excludes 
trade secret and confidential commercial information, e.g., the 
contents of a pending PMA. (See section 520(c) of the act (21 U.S.C. 
360j(c).) Section 520(h)(4) of the act provides that 6 years after the 
date FDA has approved an application FDA may, for reclassification of a 
device, use certain information contained in a PMA. Useable information 
includes data from clinical and preclinical tests or studies that 
demonstrate the safety or effectiveness of the device. This information 
does not include descriptions of methods of manufacture, product 
composition, and other trade secrets.

[[Page 61343]]

II. Regulatory History of the Device

    In the Federal Register of December 13, 2002 (67 FR 76706), FDA 
proposed to reclassify arrhythmia detector and alarm devices from class 
III to class II (special controls). These devices are used to monitor 
an electrocardiogram and to produce a visible or audible signal or 
alarm when an atrial or ventricular arrhythmia occurs. Concurrently, 
FDA proposed to separate the identification of arrhythmia detectors and 
alarms from automated external defibrillators (AEDs). FDA decided to 
address, at a later date, the possible reclassification of AEDs, 
devices primarily designed for a different intended use (i.e., to 
correct an arrhythmia) than the arrhythmia detector and alarm. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
notice of intent to reclassify AEDs.
    Also in the Federal Register of December 13, 2002 (67 FR 76749), 
FDA announced the availability of a guidance document that FDA intended 
would serve as the special control for arrhythmia detector and alarm 
devices, if FDA reclassified them. FDA gave interested persons until 
March 13, 2002, to comment on the proposed regulation and guidance 
document. FDA did not receive any comments on the proposed regulation, 
but did receive one comment on the guidance document.

III. Summary of Final Rule

    In accordance with Sec.  860.84(g)(2) (21 CFR 860.84(g)(2)) of the 
regulations, FDA is reclassifying arrhythmia detector and alarm devices 
into class II. To ensure clarity, FDA is revising the classification of 
arrhythmia detector and alarm devices by separating these devices from 
AEDs and establishing a separate classification regulation for AEDs 
(Sec.  870.5310). The guidance document entitled ``Class II Special 
Controls Guidance Document: Arrhythmia Detector and Alarm'' will serve 
as the special control for arrhythmia detector and alarm devices. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of this guidance document. Following the effective date of 
the final classification rule, any firm submitting a 510(k) premarket 
notification for the device will need to address the issues covered in 
the special controls guidance. However, the firm need only show that 
its device meets the recommendations of the guidance or in some other 
way provides equivalent assurances of safety and effectiveness.
    FDA believes that review of performance characteristics and 
labeling can ensure that acceptable levels of performance for both 
safety and effectiveness are addressed before marketing clearance. 
Thus, persons who intend to market this device must submit to FDA a 
premarket notification submission before marketing the device.

IV. Analysis of Comments and FDA's Response

    FDA received no comments on the proposed rule. Therefore, FDA is 
codifying the reclassification and special controls guidance by 
amending Sec.  870.1025. FDA is also adding a separate regulation for 
AEDs (Sec.  870.5310). For the convenience of the reader, FDA is also 
adding Sec.  870.1 to inform the reader where to find guidance 
documents referenced in part 870.

V. Environmental Impact

    FDA has determined under 21 CFR 25.34(b) that this reclassification 
action 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.

VI. Analysis of Impacts

    FDA has examined the impacts of the final 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. If regulation is necessary, a 
regulatory agency must plot a course that maximizes net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). FDA believes 
that the final rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. Additionally, as defined 
by the Executive order, the final rule does not constitute a 
significant regulatory action. As a result, the final rule 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. 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 rule will not have a significant economic impact on a 
substantial number of small entities. In addition, this 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.

VII. Federalism

    FDA has analyzed the final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, FDA has concluded that the 
rule does not contain policies that have federalism implications as 
defined in the Executive order. As a result, a federalism summary 
impact statement is not required.

VIII. Paperwork Reduction Act of 1995

    FDA concludes that the final rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget, according to the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520) is not required.

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, 21 CFR part 
870 is amended as follows:


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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

[[Page 61344]]

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.

3. Section 870.1025 is revised to read as follows:

Sec.  870.1025  Arrhythmia detector and alarm (including ST-segment 
measurement and alarm).

    (a) Identification. The arrhythmia detector and alarm device 
monitors an electrocardiogram and is designed to produce a visible or 
audible signal or alarm when atrial or ventricular arrhythmia, such as 
premature contraction or ventricular fibrillation, occurs.
    (b) Classification. Class II (special controls). The guidance 
document entitled ``Class II Special Controls Guidance Document: 
Arrhythmia Detector and Alarm'' will serve as the special control. See 
Sec.  870.1 for the availability of this guidance document.

4. Section 870.5310 is added to subpart F to read as follows:

Sec.  870.5310  Automated external defibrillator.

    (a) Identification. An automated external defibrillator (AED) 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 hearth 
rhythm) the atria or ventricles of the heart. An AED 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 
    (b) Classification. Class III (premarket approval)
    (c) Date PMA or notice of PDP is required. No effective date has 
been established of the requirement for premarket approval. See Sec.  

    Dated: October 2, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27115 Filed 10-27-03; 8:45 am]