[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1998, is withdrawn in part for Secs. 870.4200 and 890.1175 as of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
