[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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