[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Proposed Rules]
[Pages 38901-38902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18457]
Federal Register / Vol. 60, No. 145, Friday, July 28, 1995 /
Proposed Rules
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[[Page 38901]]
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
[[Page 38902]]
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