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

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1998, is withdrawn in part for Secs. 870.4200 and 890.1175 as of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

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