[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              
------------------------------------------------------------------------
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).      
------------------------------------------------------------------------

    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).      
------------------------------------------------------------------------

    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