[Federal Register Volume 65, Number 70 (Tuesday, April 11, 2000)]
[Rules and Regulations]
[Pages 19317-19319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8850]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 870, 888, and 890

[Docket No. 99N-2210]


Cardiovascular, Orthopedic, and Physical Medicine Diagnostic 
Devices; Reclassification of Cardiopulmonary Bypass Accessory 
Equipment, Goniometer Device, and Electrode Cable Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying from 
class I into class II the cardiopulmonary bypass accessory equipment 
device that involves an electrical connection to the patient, the 
goniometer device, and the electrode cable. FDA is also exempting these 
devices from the premarket notification requirements. FDA is 
reclassifying these devices on its own initiative based on new 
information. FDA is taking this action to establish sufficient 
regulatory controls that will provide reasonable assurance of the 
safety and effectiveness of these devices.

DATES:  This regulation is effective May 11, 2000.

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. Background (Proposed Rule)

    On August 9, 1999 (64 FR 43114), FDA, on its own initiative, 
proposed to reclassify the following devices from class I to class II: 
(1) Cardiopulmonary bypass accessory equipment, when intended to be 
used in the cardiopulmonary bypass circuit to support, adjoin, or 
connect components, or to aid in the setup of the extracorporeal line; 
(2) the goniometer device, which is an AC-powered device, when intended 
to evaluate joint function by measuring and recording ranges of motion, 
acceleration, or forces exerted by a joint; and (3) the electrode cable 
device, which is an electrode cable device composed of strands of 
insulated electrical conductors laid together around a central core and 
intended for medical purposes to connect an electrode from a patient to 
a diagnostic machine.
    In addition to general controls, FDA identified two special 
controls that FDA believes are adequate to control the risks to health 
described for these devices: (1) On May 9, 1997, FDA issued a final 
rule establishing a performance standard for electrode lead wires and 
patient cables. The agency determined that the performance standard is 
needed to prevent electrical connections between patients and 
electrical power sources. In the preamble to the May 9, 1997, final 
rule establishing this standard, FDA identified cardiopulmonary bypass 
accessory equipment, the goniometer, and the electrode cable as devices 
that would be subject to this standard after they were reclassified 
into class II; and (2) based on the available information, FDA also 
identified a guidance document entitled ``Guidance on the Performance 
Standard for Electrode Lead Wires and Patient Cables.'' The guidance 
provides information on electrocution hazards posed by unprotected 
patient electrical connectors. The guidance is intended to help 
affected parties understand the steps needed to achieve compliance with 
the performance standard for electrode lead wires and patient cables.
    Since May 11, 1998, electrode lead wires or patient cables have 
been required to comply with the ECG Cables and Lead Wires, ANSI/AAMI 
EC 53-1995 standard if they are intended for use with any of the 
following devices:
    1. Breathing frequency monitors,
    2. Ventilatory effort monitors (Apnea detectors),
    3. Electrocardiographs (ECG's),
    4. Radio frequency physiological signal transmitters and receivers,
    5. Cardiac monitors,
    6. Electrocardiograph electrodes (including pre-wired ECG 
electrodes),
    7. Patient transducer and electrode cables (including connectors),
    8. Medical magnetic tape recorders (e.g. Holter monitors),
    9. Arrhythmia detectors and alarms,
    10. Telephone electrocardiograph transmitters and receivers.
    Manufacturers and users had an additional 2 years to prepare for 
the second phase of implementation of the standard. Beginning on May 9, 
2000, any electrode lead wire or patient cable lead intended for use 
with any medical device must comply with the standard. The performance 
standard incorporates the specific requirements of international 
standard, IEC-60601, clause 56.3(c), which requires leads to be 
constructed in such a manner as to preclude patient contact with 
hazardous voltages or, for certain devices, contact with electrical 
ground. Design changes and labeling changes need to be

[[Page 19318]]

considered by manufacturers and importers of these devices. Adapters 
can be used to convert devices already in the marketplace so they can 
accept electrode wires and patient cables that comply with the new 
performance standard.

II. Comments

    FDA invited interested persons to submit written comments on the 
proposed rule. FDA received one comment. The comment objected that the 
rule should not apply to battery-powered goniometers.
    FDA agrees in part. Some battery-powered goniometers have cables 
and leads that connect them to displays and other devices. Because 
devices that use electrode lead wires and patient cables present the 
risk of electrocution to the patient, FDA believes that these devices 
should be in class II and subject to the standard. Goniometers that do 
not use electrode lead wires and patient cables will remain in class I 
and will be exempt from premarket notification. FDA is also revising 
the identification section in Sec. 888.1500 (21 CFR 888.1500). 
Presently, it refers only to AC-powered devices. Since publication of 
that proposed rule, FDA has found several battery-powered goniometers 
to be substantially equivalent to the goniometer identified in 
Sec. 888.1500(a). FDA is revising this section to include battery-
powered devices.

III. Exemption From Premarket Notification

A. FDA Is Exempting These Devices From Premarket Notification

    On November 21, 1997, the President signed into law the FDA 
Modernization Act (FDAMA) (Public Law 105-115). Section 206 of FDAMA, 
in part, added a new section 510(m) to the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360(m). Section 510(m)(1) of the act 
requires FDA, within 60 days after enactment of FDAMA, to publish in 
the Federal Register a list of each type of class II device that does 
not require a report under section 510(k) of the act to provide 
reasonable assurance of safety and effectiveness. Section 510(m) of the 
act further provides that a 510(k) will no longer be required for these 
devices upon the date of publication of the list in the Federal 
Register. FDA published that list in the Federal Register of January 
21, 1998 (63 FR 3142). Section 510(m)(2) of the act provides that 1 day 
after the date of publication of the list under section 510(m)(1) of 
the act, FDA may exempt a device on its own initiative or upon petition 
of an interested person, if FDA determines that a 510(k) is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. FDA has determined that, for the devices 
proposed for class II in this rule, the special controls along with 
general controls other than premarket notification will provide 
reasonable assurance of the safety and effectiveness of these devices. 
Therefore, FDA is exempting these devices from the premarket 
notification requirements subject to the applicable limitations on 
exemptions.

B. Certain Cardiopulmonary Bypass Equipment Will Remain in Class I

    FDAMA also added a new section 510(l) to the act which provides 
that a class I device is exempt from the premarket notification 
requirements under section 510(k) of the act, unless the device is 
intended for a use which is of substantial importance in preventing 
impairment of human health or it presents a potential unreasonable risk 
of illness or injury. FDA refers to the devices that meet these 
criteria as ``reserved.'' In the Federal Register of February 2, 1998 
(63 FR 5387), FDA published a list of devices it considered reserved 
and that require premarket notification and a list of devices it 
believed met the exemption criteria in FDAMA. FDA invited comments on 
the February 2, 1998, notice. In the Federal Register of November 12, 
1998 (63 FR 63222), after reviewing the comments submitted on the 
February 2, 1998, Federal Register notice, FDA proposed to designate 
which devices require premarket notification, and which are exempt, 
subject to limitations, under notice and comment rulemaking proceedings 
under new section 510(l) of the act. One comment on the proposed rule 
stated that, for cardiopulmonary bypass accessory equipment, the 
``reserved'' designation should be limited to accessory equipment that 
involves an electrical connection to the patient. FDA agrees with this 
comment and, on January 14, 2000 (65 FR 2296), FDA issued a final rule 
on exemptions from premarket notification to adopt this comment. In 
this rule, FDA stated that cardiopulmonary bypass accessory equipment 
that does not involve electrical connection to the patient is a class I 
device and is exempt from the premarket notification requirements.

IV. Environmental Impact

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

V. Analysis of Impacts

    FDA has examined the impacts of the rule under Executive Order 
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended 
by subtitle D of the Small Business Regulatory Fairness Act of 1996 
(Public Law 104-121)), 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 rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
In addition, the 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. Based on the May 9, 1997 (62 FR 25477), Federal 
Register, a final rule was issued establishing a performance standard 
for electrode lead wires and patient cables, which included and applied 
to the cardiopulmonary bypass accessory equipment that involves an 
electrical connection to the patient, the goniometer, and the electrode 
cable. FDA's analysis determined that the imposition of the performance 
standard would not have a significant economic impact on a substantial 
number of small entities. This reclassification will have no economic 
effect other than the imposition of this standard. In addition, the 
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 or analysis under section 
202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

VI. Paperwork Reduction Act of 1995

    FDA has determined that this rule contains no collections of 
information. Therefore, clearance from the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Parts 870, 888, and 890

    Medical devices.

[[Page 19319]]

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
870, 888, and 890 are amended as 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 870.4200 is revised to read as follows:


Sec. 870.4200  Cardiopulmonary bypass accessory equipment.

    (a) Identification. Cardiopulmonary bypass accessory equipment is a 
device that has no contact with blood and that is used in the 
cardiopulmonary bypass circuit to support, adjoin, or connect 
components, or to aid in the setup of the extracorporeal line, e.g., an 
oxygenator mounting bracket or system-priming equipment.
    (b) Classification. (1) Class I. The device is classified as class 
I if it does not involve an electrical connection to the patient. The 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to Sec. 870.9.
    (2) Class II (special controls). The device is classified as class 
II if it involves an electrical connection to the patient. The special 
controls are as follows:
    (i) The performance standard under part 898 of this chapter, and
    (ii) The guidance document entitled ``Guidance on the Performance 
Standard for Electrode Lead Wires and Patient Cables.'' The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 870.9.

PART 888--ORTHOPEDIC DEVICES

    3. The authority citation for 21 CFR part 888 continues to read as 
follows:

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

    4. Section 888.1500 is revised to read as follows:


Sec. 888.1500  Goniometer.

    (a) Identification. A goniometer is an AC-powered or battery 
powered device intended to evaluate joint function by measuring and 
recording ranges of motion, acceleration, or forces exerted by a joint.
    (b) Classification. (1) Class I (general controls) for a goniometer 
that does not use electrode lead wires and patient cables. This device 
is exempt from the premarket notification procedures of subpart E of 
part 807 of this chapter subject to Sec. 888.9.
    (2) Class II (special controls) for a goniometer that uses 
electrode lead wires and patient cables. The special controls consist 
of:
    (i) The performance standard under part 898 of this chapter, and
    (ii) The guidance entitled ``Guidance on the Performance Standard 
for Electrode Lead Wires and Patient Cables.'' This device is exempt 
from the premarket notification procedures of subpart E of part 807 of 
this chapter subject to Sec. 888.9.

PART 890--PHYSICAL MEDICINE DEVICES

    5. The authority citation for 21 CFR part 890 continues to read as 
follows:

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

    6. Section 890.1175 is amended by revising paragraph (b) to read as 
follows:


Sec. 890.1175  Electrode cable.

* * * * *
    (b) Classification. Class II (special controls). The special 
controls consist of:
    (1) The performance standard under part 898 of this chapter, and
    (2) The guidance document entitled ``Guidance on the Performance 
Standard for Electrode Lead Wires and Patient Cables.'' This device is 
exempt from the premarket notification procedures of subpart E of part 
807 of this chapter subject to Sec. 890.9.

    Dated: March 2, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-8850 Filed 4-10-00; 8:45 am]
BILLING CODE 4160-01-F