[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Proposed Rules]
[Pages 43114-43117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20357]


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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 the Cardiopulmonary Bypass Accessory 
Equipment, Goniometer Device, and the Electrode Cable Devices

AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the cardiopulmonary bypass accessory equipment device that 
involves an electrical connection to the patient, the goniometer 
device, and the electrode cable from class I into class II. FDA is also 
proposing to exempt these devices from the premarket notification 
requirements. This classification is being proposed on FDA's own 
initiative based on new information. This action is being taken to 
establish sufficient regulatory controls that will provide reasonable 
assurance of the safety and effectiveness of these devices.

DATES: Written comments by November 8, 1999. See section IX of this 
document for the proposed effective date of a final rule based on this 
document.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1061, 5630 Fishers Lane, Rockville, 
MD 20852.
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 (Regulatory Authorities)

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629), and the 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 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 1976 
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 postamendments devices, are classified 
automatically by statute (section 513(f) of the act (21 U.S.C. 360c(f)) 
into class III without any FDA rulemaking process. Those devices

[[Page 43115]]

remain in class III and require premarket approval, unless and until: 
(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 new 
section 513(f)(2) of the act, as amended by the FDAMA; or (3) FDA 
issues an order finding the device to be substantially equivalent, 
under section 513(i) of the act (21 U.S.C. 360c(i)), 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 part 807 of the regulations (21 CFR 
part 807).
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act (21 U.S.C. 360c(e)). This section provides 
that FDA may, by rulemaking, reclassify a device (in a proceeding that 
parallels the initial classification proceeding) 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); 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 (21 U.S.C. 360c(a)(3)) and 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. 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 
premarket approval application. (See section 520 of the act (21 U.S.C. 
360j(c)).

II. Regulatory History of Devices

    In accordance with section 513(e) of the act and 21 CFR 
860.130(a)(1), based on new information with respect to the devices, 
FDA, on its own initiative, is proposing 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 a 
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.

III. Device Description

    FDA is maintaining the following device descriptions and intended 
uses:
     (1) The cardiopulmonary bypass accessory equipment are devices 
that have no contact with blood and are intended 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. FDA is reclassifying into class II 
only cardiopulmonary bypass accessory equipment that involves an 
electrical connection to the patient. Other accessory equipment remains 
in class I.
    (2) The goniometer is an ac-powered device intended to evaluate 
joint function by measuring and recording ranges of motion, 
acceleration, or forces exerted by a joint.
    (3) The electrode cable device is a 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.

IV. Risk to Health

    After several incidents were reported to FDA, pertaining to the 
risk of patient exposure to macro shock or electrocution, FDA took 
action to address the problem. A summary of the incidences was 
published in a final rule that established a performance standard for 
electrode lead wires and patient cables (62 FR 25477, May 9, 1997). 
Industry also took steps to prevent electrode lead wires from being 
connected to electrical power sources; a public conference sponsored by 
Health Industry Manufacturers Association and the American Hospital 
Association, held on July 15, 1994, provided a forum for device users, 
manufacturers, and other health care professionals to offer and hear 
comments for FDA's consideration during the rulemaking process.

V. Summary of Reasons for Reclassification

    Based on new information with respect to the devices and in 
accordance with section 513 (e) of the act and 21 CFR 860.130(a)(1), 
FDA, on its own initiative, is proposing to reclassify the 
cardiopulmonary bypass accessory equipment devices that involve an 
electrical connection to the patient, the goniometer ac-powered device, 
and the electrode cable device from class I into class II. The agency 
is taking this action because the new information shows that these 
products present a degree of health risk to the patient that cannot be 
addressed by class I general controls. The agency established a 
performance standard for electrode lead wires and patient cables to 
prevent electrical connections between patients and electrical power 
sources. FDA believes the cardiopulmonary bypass accessory equipment, 
the ac-powered goniometer, and the electrode cable should be 
reclassified into class II because special controls in addition to 
general controls, provide reasonable assurance of safety and 
effectiveness of the device, and there is sufficient information to 
establish special controls to provide such assurance.

VI. Summary of Data Upon Which the Reclassification is Based

    FDA believes that, in order to eliminate the risk of macro shock 
and electrocution in the future, a mandatory performance standard must 
apply to all electrode lead wires and patient cables intended for use 
with medical devices.

[[Page 43116]]

    Based on the available information, FDA believes that the special 
controls discussed below are capable of providing reasonable assurance 
of the safety and effectiveness of the cardiopulmonary bypass accessory 
equipment that involves an electrical connection to the patient, the 
goniometer device, and the electrode cable with regard to the 
identified risks to health of these devices.

VII. Special Controls

    In addition to general controls, FDA believes that the special 
controls identified in this document 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. (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 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.

VIII. Exemption from Premarket Notification

A. FDA is proposing to exempt these devices from premarket 
notification.

    On November 21, 1997, the President signed into law FDAMA (Public 
Law 105-115). Section 206 of FDAMA, in part, added a new section 510(m) 
to 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 (21 U.S.C. 360(k)) 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 proposing to 
exempt 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). 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 
intends to change the final rule on exemptions from premarket 
notification to adopt this comment. In this proposed rule, FDA is 
stating 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.

IX. Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 30 days after its date of publication in the 
Federal Register.

X. 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.

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) (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

[[Page 43117]]

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. 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. The 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, if 
finalized, will have no economic effect other than the imposition of 
this standard. In addition, the proposed rule, if finalized, 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.

XII. Paperwork Reduction Act of 1995

    FDA has tentatively determined that this proposed 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.

XIII. Submission of Comments

    Interested persons may, on or before November 8 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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.

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

    Medical Devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 870, 888, and 890 be 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:
    (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.'' 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 DIAGNOSTIC 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 amended by revising paragraph (b) to read as 
follows:


Sec. 888.1500  Goniometer.

* * * * *
    (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 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 PROSTHETIC 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: July 25, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-20357 Filed 8-6-99; 8:45 am]
BILLING CODE 4160-01-F