[Federal Register Volume 65, Number 10 (Friday, January 14, 2000)]
[Proposed Rules]
[Page 2364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-885]



[[Page 2364]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 870 and 890

[Docket No. 98N-0009]


Medical Devices; Revocation of Exemptions from Premarket 
Notification for Certain Cardiovascular and Physical Medicine Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal in part.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing in part 
its proposed rule that published in the Federal Register of November 
12, 1998 (63 FR 63222), to revoke the exemptions from the requirement 
of premarket notification of a cardiovascular device (cardiopulmonary 
bypass accessory equipment) and a physical medicine device (electrode 
cable). Elsewhere in this issue of the Federal Register, FDA is issuing 
a final rule to exempt other devices from the requirement of premarket 
notification.

DATES: The proposed rule that published at 63 FR 63222, November 12, 
1998, is withdrawn in part for Secs. 870.4200 and 890.1175 as of 
January 14, 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: On November 21, 1997, the President signed 
the Food and Drug Administration Modernization Act of 1997 (FDAMA) into 
law (Public Law 105-115). Section 206 of FDAMA, in part, added a new 
section 510(l) to the Federal Food, Drug, and Cosmetic Act (the act). 
Under section 206 of FDAMA, new section 510(l) of the act became 
effective on February 19, 1998. New section 510(l) of the act 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 devices that FDA believes meet 
these criteria as ``reserved.'' FDA has evaluated all class I devices 
to determine which device types should be subject to premarket 
notification requirements.
     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.
     FDA had proposed two rules that relate to the classification and 
premarket notification status of cardiopulmonary bypass accessory 
equipment (21 CFR 870.4200) and electrode cables (21 CFR 890.1175). In 
the November 12, 1998, proposed rule after reviewing the comments 
submitted on the February 2, 1998, 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. At that time, FDA also proposed to 
revoke existing exemptions for certain devices from premarket 
notification, including those for cardiopulmonary bypass accessory 
equipment and the electrode cable.
     In the Federal Register of August 9, 1999 (64 FR 43114), FDA 
published a proposed rule to reclassify three devices into class II in 
order to make them subject to the performance standard for electrode 
lead wires and patient cables, including cardiopulmonary bypass 
accessory equipment that involves an electrical connection to the 
patient and the electrode cable. Because FDA believes that compliance 
with the performance standard for electrode lead wires and patient 
cables will provide adequate assurance of the safety and effectiveness 
of these devices, the proposal provides that these devices would be 
exempt from the premarket notification requirements.
     Under the August 9, 1999, proposed rule, cardiopulmonary bypass 
accessory equipment that does not involve an electrical connection to 
the patient would remain in class I and would be exempt from the 
premarket notification requirements. FDA expects to finalize the August 
9, 1999, proposed rule in the very near future. If the rule is 
finalized, the devices will be exempt from the premarket notification 
requirements and all such devices will be subject to the performance 
standard for electrode lead wires and patient cables, when the rule 
becomes effective for those devices on May 9, 2000.
     If FDA were to finalize the November 12, 1998, proposed rule to 
revoke the existing premarket notification exemptions for 
cardiopulmonary bypass accessory equipment and the electrode cable, the 
manufacturers of these devices would have to comply with the premarket 
notification requirements only during the interim period until the 
proposed rule to make these devices class II exempt is finalized. FDA 
believes that there is no reason to require premarket notification for 
these devices during the short interval between these two final rules. 
Therefore, FDA is withdrawing in part its proposed rule to revoke the 
exemption from the premarket notification requirements for the 
cardiopulmonary bypass accessory equipment and the electrode cable.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs, the 
proposed rule published on November 12, 1998 (63 FR 63222) is withdrawn 
in part for Secs. 870.4200 and 890.1175.

    Dated: December 22, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-885 Filed 1-13-00; 8:45 am]
BILLING CODE 4160-01-F