Medical Devices; Withdrawal of Proposed Exemptions

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, and 886

[Docket No. 94M-0260]

Medical Devices; Withdrawal of Proposed Exemptions

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing

proposals to exempt seven generic types of class I devices from the

requirement of premarket notification. Elsewhere in this issue of the

Federal Register, FDA is publishing a final rule exempting nine generic

types of class I devices from the requirement of premarket

notification. Also elsewhere in this issue of the Federal Register, the

agency is proposing to exempt an additional 12 generic types of class I

devices from the requirement of premarket notification. These actions

are being taken under the Medical Device Amendments of 1976.

FOR FURTHER INFORMATION CONTACT: Lisa A. Rooney, Center for Devices and

Radiological Health (HFZ-84), Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 164.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 21, 1994 (59 FR 37378), FDA issued

a proposed rule to exempt 164 generic types of class I devices from the

requirement of premarket notification, with limitations. Interested

persons were given until October 19, 1994, to comment on the proposed

rule.

During the comment period, FDA received comments which questioned

the appropriateness of the proposed exemptions for a small number of

the devices. FDA also received comments requesting the agency to exempt

56 additional generic types of devices. Furthermore, during this time,

FDA was reconsidering the appropriateness or scope of the proposed

exemptions for several of the devices included in the proposed rule. In

the Federal Register of December 7, 1994 (59 FR 63005), FDA issued a

final rule exempting from the requirement of premarket notification 148

of the 164 generic types of class I devices included in the July 21,

1994, proposed rule. In the preamble to that rule, the agency stated

that, in a future Federal Register notice, it would address the

requests concerning the 56 additional devices, and that it was

deferring action on the following 16 devices in order to review the

comments received and to reevaluate whether certain of the devices

should be exempted from the requirement of premarket notification. (See

Table 1).

Table 1

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21 CFR Device

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862.2270........................... Thin-layer chromatography system

for clinical use.

862.2310........................... Clinical sample concentrator.

862.2320........................... Beta or gamma counter for clinical

use.

862.2485........................... Electrophoresis apparatus for

clinical use.

862.2720........................... Plasma oncometer for clinical use.

862.2800........................... Refractometer for clinical use.

862.2920........................... Plasma viscometer for clinical use.

864.2280........................... Cultured animal and human cells.

866.5570........................... Lactoferrin immunological test

system.

868.5620........................... Breathing mouthpiece.

868.5675........................... Rebreathing device.

868.5700........................... Nonpowered oxygen tent.

872.3740........................... Retentive and splinting pin.

872.3810........................... Root canal post.

872.6100........................... Anesthetic warmer.

886.5850........................... Sunglasses (nonprescription).

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FDA has reviewed the comments and reconsidered the appropriateness

or scope of the proposed exemptions for the devices listed above. Upon

review and reconsideration, FDA is withdrawing its proposal to exempt

six of the devices because the agency has determined that the devices

do not meet the criteria for granting such exemptions. These criteria

are described in the preamble of the July 21, 1994, proposal.

Furthermore, at this time, the agency is withdrawing its proposal to

exempt sunglasses (nonprescription) (Sec. 886.5850) in order to review

the large number of comments concerning the proposed limited exemption

applicable to this device; however, the agency is continuing to look at

ways to appropriately provide an exemption.

The devices for which the proposed exemptions are being withdrawn

are listed below.

Table 2

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21 CFR Device

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862.2270........................... Thin-layer chromatography system

for clinical use.

864.2280........................... Cultured animal and human cells.

866.5570........................... Lactoferrin immunological test

system.

868.5620........................... Breathing mouthpiece.

868.5675........................... Rebreathing device.

868.5700........................... Nonpowered oxygen tent.

886.5850........................... Sunglasses (nonprescription).

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Elsewhere in this issue of the Federal Register, FDA is publishing

a final rule exempting 9 devices from the requirement of premarket

notification and responding to requests to exempt 56 additional generic

types of devices.

II. Summary and Analysis of Comments and FDA's Response

A professional association commented that four anesthesia related

devices, the breathing mouthpiece (Sec. 868.5620); the rebreathing

device (Sec. 868.5675); the nonpowered oxygen tent (Sec. 868.5700); and

the anesthetic warmer (Sec. 872.6100), should not be exempted from the

requirement of premarket notification for the reasons stated below.

A. Breathing Mouthpiece (Sec. 868.5620)

This association commented that it would be inappropriate to exempt

this generic type of class I device from the requirement of premarket

notification because a ``breathing mouthpiece'' may be interpreted to

include certain devices for which FDA endorses standard specifications.

According to this comment, these detailed standard specifications were

established to provide order to the design, performance, and

manufacturing of selected airway devices, connectors, and appropriate

related apparatus which may be construed as ``mouthpieces.''

B. Rebreathing Device (Sec. 868.5675)

This association stated that certain anesthesia machines, volume

ventilators, and resuscitation devices are equipped with nonrebreathing

and rebreathing devices, used as components within these systems.

Certain rebreathing devices have been directly related to death,

serious injury, and serious illness resulting from complications caused

by their design, performance, use, and misuse. As a result, the comment

contends that rebreathing devices should not be exempt from premarket

notification requirements.

C. Nonpowered Oxygen Tent (Sec. 868.5700)

According to this association, the word ``nonpowered'' is

confusing and inappropriate to use to specify a type of oxygen tent

because, even if electronic controls are not present and electric power

is not required, a pneumatic

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system will ``power'' an oxygen delivery tent. The association stated

that such a pneumatic powered oxygen tent falls within the

classification of an oxygen administration system which must satisfy

certain criteria and specifications. According to the association,

review of premarket notification submissions is the only way to ensure

that these devices conform to these criteria and specifications. Thus,

the association concluded, these devices should not be exempt from the

premarket notification requirements.

D. Anesthetic Warmer (Sec. 872.6100)

This comment was concerned that the words ``anesthetic warmer''

could be applied literally to refer to certain anesthesiology devices

associated with known cases of injury, device failure, and misuse.

Further, the comment stated that ``anesthetic warmer'' could be applied

to anesthesiology devices which are required to follow performance and/

or safety specifications.

FDA agrees that the breathing mouthpiece (Sec. 868.5620); the

rebreathing device (Sec. 868.5675); and the nonpowered oxygen tent

(Sec. 868.5700) should not be exempt from the requirement of premarket

notification. Thus, the agency is withdrawing the proposed exemptions

for these devices because these devices have a significant history of

risk and/or characteristics of the devices necessary for their safe and

effective performance are not well established. However, FDA has

concluded that the anesthetic warmer (Sec. 872.6100) should be exempt

from the requirement of premarket notification. Moreover, FDA believes

that the identification of this device is sufficiently clear to exclude

the devices referred to in the comment.

III. Reconsideration of the Appropriateness or Scope of the

Exemptions

FDA reconsidered the appropriateness of exempting cultured animal

and human cells (Sec. 864.2280) from the requirement of premarket

notification.

FDA is withdrawing the proposed exemption for this device because,

upon reconsideration, the agency has determined that the device does

not meet the exemption criteria. The device is comprised of either

continuous cell or primary cell lines for the isolation and

identification of various pathogenic organisms. If the cells are

continuous lines, it must be assured that a mechanism is in place for

the manufacturer to determine that the cell line has not changed from

the original cell type. After prolonged passages cell lines will

deviate from the original cell line and the sensitivity for isolation

of organisms is decreased. On the other hand, if the cell line is

primary, there must be assurance that the cell line is not contaminated

with adventitious organisms which may preclude the isolation or

identification of the pathogen from the patient. Sometimes it is not

readily apparent whether the cells are contaminated with adventitious

organisms. Furthermore, with the advent of genetically engineered cell

lines for identification of specific organisms, information must be

reviewed to determine whether the genetically engineered cell lines

will function as claimed. Also, it must be assured that the labeling is

consistent with the effectiveness and use of the specific cell. If an

applicant wishes to make effectiveness or use claims which are not

supported in the literature, appropriate studies are required to

validate these claims. If the device is inappropriately labeled, the

risk of incorrect diagnosis or ineffective treatment may be increased.

Upon reconsideration, FDA is withdrawing the proposed exemption for

the lactoferrin immunological test system (Sec. 886.5570) because it is

anticipated that there may be significant changes to this device that

could affect its safety and effectiveness. Such changes could involve

new intended uses and new matrices for which the agency has no

information or data. The device is not well characterized and any

anticipated changes that could affect safety or effectiveness are not

readily detectable by any means and could increase the risk of

incorrect diagnosis. Similarly, it must be assured that the labeling

for the device is appropriate and accurate for the proposed claims. If

the device is not appropriately labeled and the performance

established, there may be an increased risk of misdiagnosis.

FDA is also withdrawing the proposed exemption for the thin-layer

chromatography system for clinical use (Sec. 862.2270). Upon further

review, FDA has determined that any anticipated changes that could

affect the safety and effectiveness of the device are not readily

detectable by any means and could materially increase the risk of

incorrect diagnosis.

Therefore, under the Federal Food, Drug, and Cosmetic Act (secs.

513 and 701(a) (21 U.S.C. 360c and 371(a)) and under 21 CFR 5.10, the

proposed rule published in the Federal Register of July 21, 1994, is

withdrawn with respect to the 7 devices cited in Table 2 of this

document.

Dated: July 18, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95-18457 Filed 7-27-95; 8:45 am]

BILLING CODE 4160-01-F