[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Rules and Regulations]
[Pages 38896-38900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18458]




[[Page 38895]]

_______________________________________________________________________

Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Part 862 et al.



Medical Devices: Class I and Class II Generic Devices; Premarket 
Notification Exemptions; Final Rule and Proposed Rules

  Federal Register / Vol. 60, No. 145 / Friday, July 28, 1995 / Rules 
and Regulations   

[[Page 38896]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862 and 872

[Docket No. 94M-0260]


Medical Devices; Exemption From Premarket Notification for 
Certain Classified Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is exempting nine 
generic types of class I devices from the requirement of premarket 
notification. For the exempted devices, FDA has determined that 
manufacturers' submissions of premarket notifications are unnecessary 
for the protection of the public health and that the agency's review of 
such submissions will not advance its public health mission. The 
exemptions allow the agency to make better use of its resources and 
thus better serve the public. Elsewhere in this issue of the Federal 
Register, FDA is publishing a withdrawal of a proposed rule to grant 
exemptions from premarket notification for seven other generic types of 
class I devices. Also, 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.

DATES: Effective August 28, 1995. Beginning on August 28, 1995, all 
device manufacturers who have 510(k) submissions pending FDA review for 
devices falling within a generic category which is subject to this 
rule, will receive a letter stating that the device is exempt from the 
premarket notification requirements of the Federal Food, Drug, and 
Cosmetic Act.

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 that 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 reconsidered the appropriateness or scope of the proposed 
exemptions for several 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 the final 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                                
------------------------------------------------------------------------
               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).      
------------------------------------------------------------------------

    After careful review of the comments and reconsideration of the 
appropriateness or scope of the proposed exemptions for these devices, 
the agency has concluded that for 9 of the 16 generic types of class I 
devices listed in Table 1, manufacturers' submissions of premarket 
notifications are unnecessary for the protection of the public health 
and that the agency's review of such submissions will not advance its 
public health mission. These nine devices are listed in Table 2.

                                 Table 2                                
------------------------------------------------------------------------
               21 CFR                               Device              
------------------------------------------------------------------------
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.
872.3740...........................  Retentive and splinting pin.       
872.3810...........................  Root canal post.                   
872.6100...........................  Anesthetic warmer.                 
------------------------------------------------------------------------

    FDA, upon reconsideration, has determined not to grant the proposed 
exemptions for the following seven devices. (See Table 3).

                                 Table 3                                
------------------------------------------------------------------------
               21 CFR                               Device              
------------------------------------------------------------------------
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 withdrawal of the proposed rule to grant exemptions from the 
requirement of premarket notification for the seven devices listed 
above. FDA's reasons for deciding not to exempt those seven devices are 
given in that withdrawal document.
    Furthermore, after reviewing the comments requesting FDA to exempt 
from the requirement of premarket notification 56 additional generic 
types of devices, FDA has concluded that 33 of these 56 devices should 
not be exempted from the requirement. As stated below in this document, 
10 of these 56 devices, along with 2 additional class I devices, are 
being proposed for premarket notification exemption elsewhere in this 
issue of the Federal Register. Thirteen of the 56 devices already are 
exempted from the requirement of premarket notification.

II. Comments

    FDA received 10 comments from trade associations, manufacturer 
associations, a dental firm, a consumer products manufacturer, a 
company, and a law firm. A summary of the comments and the agency's 
response to them is provided below.

[[Page 38897]]


A. Comments Addressing Specific Devices

    1. One comment opposed the proposed exemptions from the requirement 
of premarket notification for the retentive and splinting pin 
(Sec. 872.3740) and the root canal post (Sec. 872.3810). According to 
this comment, premarket notification submissions are necessary to 
ensure that the material used in these devices are biocompatable in 
order to prevent toxicity and/or allergic reactions. The comment also 
stated that, because teeth are delicate, these devices must be designed 
so that no undue stress will be imparted upon the teeth. According to 
this comment, exempting these devices from premarket notification would 
result in substandard products being made available to dental 
professionals. Another comment in favor of the exemption disagreed, 
stating that it is the ``method of use and application'' of these 
devices, not the design or materials used in them that is the 
determining factor in the safe and effective use of these devices. 
Moreover, according to this comment, data relating to these devices 
demonstrate that these devices are well-known, established, safe, and 
effective.
    FDA has concluded that exempting these devices from the requirement 
of premarket notification will not result in the marketing of 
substandard devices. First, both devices have a long history of safe 
use. Second, neither device has a history of adverse events. Third, 
literature indicates little potential for any danger to public health. 
Finally, the device identifications clearly describe the material 
composition of these devices. If devices are made of materials other 
than those described in the identification, they will be classified 
into another generic type of device or remain in the same generic type 
of device, but not be exempt from the requirements of premarket 
notification.
    2. A comment requested that the proposed exemption for 
carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid 
calcium-sodium double salt denture adhesive (Sec. 872.3490) be expanded 
to include other double salts of polyvinylmethylether maleic acid, 
specifically salts involving those ions that achieve the same technical 
effect as calcium and sodium, i.e., iron, magnesium, zinc, and 
potassium.
    FDA disagrees with this comment. Although the comment refers to 
carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid 
calcium-sodium double salt denture adhesive (Sec. 872.3490), a class I 
device, the comment is actually requesting FDA to exempt another 
classified dental adhesive device, polyvinylmethylether maleic 
anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium 
(NACMC) denture adhesive (Sec. 872.3500) which is a class III device.
    3. FDA received a comment requesting that an endolumina illuminated 
bougie (EIB) device, a silicone elastomer coated fiberoptic bundle 
designed to aid in the identification of the esophagus, rectum, 
rectosigmoid, and other organs during surgical procedures, be added to 
the list of class II, tier 1 devices to be proposed for exemption from 
the requirement of premarket notification in a future issue of the 
Federal Register.
    FDA disagrees with this comment. As stated in the July 21, 1994, 
proposal, in early 1994, FDA's Office of Device Evaluation undertook a 
risk assessment of all devices in order to ensure the proper allocation 
of resources for the review process. Under this risk assessment, all 
class I, class II, and class III devices were placed into one of three 
tiers based upon the inherent risk associated with each device. Tier 3 
devices include all first and second of a kind devices utilizing new 
technology or having new intended uses(s), as well as other devices 
determined by their inherent risk to require an intensive review. These 
tier 3 devices require intensive scientific and labeling review by a 
review team as well as advisory panel input. Tier 2 devices include 
devices which require routine scientific and labeling review. This tier 
encompasses the majority of 510(k)'s and select premarket approval 
applications. Tier 1 devices include, among other things, devices which 
have a minimal inherent risk and whose review focuses upon intended 
use.
    FDA had found EIB to be substantially equivalent to both the 
gastroenterology-urology fiberoptic retractor (Sec. 876.4530), a class 
I device and the class I transilluminator (Sec. 886.1945). However, 
upon further consideration, FDA now believes that EIB would have been 
more appropriately classified under the fiberoptic light ureteral 
catheter (Sec. 876.4020), a class II device, which is also a fiberoptic 
bundle that emits light, but is inserted into the ureter to enable it 
to be seen during lower abdominal or pelvic surgery. While the specific 
indication statement for these two devices are different, their 
intended uses are the same and, therefore, the devices are 
substantially equivalent. Like the fiberoptic light ureteral catheter, 
EIB is used with a high intensity light source, which could produce 
heating and potential damage of body tissues. Concerns identified at 
the time of classification of the fiberoptic light ureteral catheter 
included thermal burns related to the amount of energy transmitted. For 
this reason, FDA has placed the fiberoptic light ureteral catheter in 
class II, tier 2. Additionally, endoscopes (which could have been 
another predicate) and esophageal dilators (which include the 
esophageal bougie) are also tier 2 devices. Furthermore, retaining the 
EIB device in class II, tier 2 is justified because EIB is a one-of-a-
kind device. FDA has not yet had sufficient experience with this device 
to justify a tier 1 premarket review, i.e., a focused labeling review 
for intended use/indications for use. For the reasons stated above, the 
EIB device will remain a class II, tier 2 device.

B. Comments Requesting FDA to Expand the Exemption from the Requirement 
of Premarket Notification to Include an Additional 56 Devices

    4. A total of eight comments requested that the 56 devices listed 
in Table 4 also be exempted from the requirement of premarket 
notification.

                                 Table 4                                
------------------------------------------------------------------------
               21 CFR                               Device              
------------------------------------------------------------------------
862.2230...........................  Chromatographic separation material
                                      for clinical use.                 
862.2250...........................  Gas liquid chromatography system   
                                      for clinical use.                 
866.2600...........................  Wood's fluorescent lamp.           
868.1930...........................  Stethoscope head.                  
872.3310...........................  Coating material for resin         
                                      fillings.                         
872.3730...........................  Pantograph.                        
872.3820...........................  Root canal filling resin.          
872.4200...........................  Dental handpiece and accessories.  
872.5470...........................  Orthodontic plastic bracket.       
872.5500...........................  Extraoral orthodontic headgear.    
872.6050...........................  Saliva absorber.                   
872.6390...........................  Dental floss (including devices    
                                      made of any inert materials).     
872.6770...........................  Cartridge syringe.                 
874.1060...........................  Acoustic chamber for audiometric   
                                      testing.                          
874.4140...........................  Ear, nose, and throat bur.         
874.4175...........................  Nasopharyngeal catheter.           
874.4770...........................  Otoscope.                          
874.5220...........................  Ear, nose, and throat drug         
                                      administration device.            
874.5800...........................  External nasal splint.             
876.4890...........................  Urological table and accessories   
                                      (manually powered).               
876.5160...........................  Urological clamp for males.        
876.5250...........................  Urine collector and accessories    
                                      (not connected to indwelling      
                                      catheter).                        
878.4040...........................  Surgical apparel (except surgical  
                                      gowns and masks).                 
878.4460...........................  Surgeon's gloves.                  
880.5110...........................  Hydraulic adjustable hospital bed. 

[[Page 38898]]
                                                                        
880.5120...........................  Manual adjustable hospital bed.    
880.5180...........................  Burn sheet.                        
880.6250...........................  Patient examination glove.         
880.6280...........................  Medical insole.                    
880.6350...........................  Battery-powered medical examination
                                      light.                            
880.6970...........................  Liquid crystal vein locator.       
884.5150...........................  Nonpowered breast pump.            
884.5425...........................  Scented or scented deodorized      
                                      menstrual pad.                    
884.5435...........................  Unscented menstrual pad.           
886.4370...........................  Keratome (AC powered).             
888.5960...........................  Cast removal instrument (AC        
                                      powered).                         
892.1300...........................  Nuclear rectilinear scanner.       
892.1320...........................  Nuclear uptake probe.              
892.1330...........................  Nuclear whole body scanner.        
892.1410...........................  Nuclear electrocardiograph         
                                      synchronizer.                     
892.1610...........................  Diagnostic x-ray beam limiting     
                                      device.                           
892.1620...........................  Cine or spot flourographic x-ray   
                                      camera.                           
892.1760...........................  Diagnostic x-ray tube housing      
                                      assembly.                         
892.1770...........................  Diagnostic x-ray tube mount.       
892.1830...........................  Radiographic patient cradle.       
892.1850...........................  Radiographic film cassette.        
892.1860...........................  Radiographic film/cassette changer.
892.1880...........................  Wall-mounted radiographic cassette 
                                      holder.                           
892.1890...........................  Radiographic film illuminator.     
892.1910...........................  Radiographic grid.                 
892.1970...........................  Radiographic ECG/respirator        
                                      synchronizer.                     
892.1980...........................  Radiologic table.                  
892.5770...........................  Powered radiation therapy patient  
                                      support assembly.                 
892.5780...........................  Light beam patient position        
                                      indicator.                        
892.5930...........................  Therapeutic x-ray tube housing     
                                      assembly.                         
892.6500...........................  Personnel protective shield.       
------------------------------------------------------------------------



    FDA has concluded that 18 of the 56 devices listed in Table 4 are 
not candidates for exemption from the requirement of premarket 
notification because they are currently classified into class II and/or 
class III. These devices are listed in Table 5.

                                 Table 5                                
------------------------------------------------------------------------
               21 CFR                               Device              
------------------------------------------------------------------------
872.3310...........................  Coating material for resin         
                                      fillings.                         
872.3820...........................  Root canal filling resin.          
872.5470...........................  Orthodontic plastic bracket.       
872.5500...........................  Extraoral orthodontic headgear.    
872.6770...........................  Cartridge syringe.                 
884.5425...........................  Scented or scented deodorized      
                                      menstrual pad.                    
892.1610...........................  Diagnostic x-ray beam limiting     
                                      device.                           
892.1620...........................  Cine or spot flourographic x-ray   
                                      camera.                           
892.1760...........................  Diagnostic x-ray tube housing      
                                      assembly.                         
892.1770...........................  Diagnostic x-ray tube mount.       
892.1830...........................  Radiographic patient cradle.       
892.1850...........................  Radiographic film cassette.        
892.1860...........................  Radiographic film/cassette changer.
892.1880...........................  Wall-mounted radiographic cassette 
                                      holder.                           
892.1980...........................  Radiologic table.                  
892.5770...........................  Powered radiation therapy patient  
                                      support assembly.                 
892.5780...........................  Light beam patient position        
                                      indicator.                        
892.5930...........................  Therapeutic x-ray housing assembly.
------------------------------------------------------------------------

    In accordance with section 513(e)(1) of the act (21 U.S.C. 
360c(e)(1)), any interested person may petition FDA to reclassify a 
device based on new information respecting such a device and to exempt 
such a device from the requirement of premarket notification. The form 
and content required for such a petition are set forth in 21 CFR 
860.123. The request and reasons supporting the request for exemption 
from the requirement of premarket notification should be included in 
the supplemental data sheet. If a device is reclassified into class I, 
FDA may also exempt the device from the requirement of premarket 
notification.
     Thirteen of the 56 devices listed in Table 4 have already been 
exempted from premarket notification procedures on the dates listed 
below. These devices are listed in Table 6.

                                 Table 6                                
------------------------------------------------------------------------
                    Federal Register                                    
       Date             citation           21 CFR            Device     
------------------------------------------------------------------------
Nov. 9, 1982.....  47 FR 50823......  866.2600........  Wood's          
                                                         fluorescent    
                                                         lamp.          
June 12, 1989....  54 FR 25042......  868.1930........  Stethoscope     
                                                         head.          
Aug. 12, 1987....  52 FR 30082......  872.3730........  Pantograph.     
Apr. 5, 1989.....  54 FR 13828......  872.6050........  Saliva absorber.
Dec. 7, 1994.....  59 FR 63005......  874.5220........  Ear, nose, and  
                                                         throat drug    
                                                         administration 
                                                         device.        
Aug. 25, 1987....  52 FR 32110......  874.5800........  External nasal  
                                                         splint.        
June 12, 1989....  54 FR 25042......  876.4890........  Urological table
                                                         and accessories
                                                         (manually      
                                                         powered).      
June 12, 1989....  54 FR 25042......  880.5110........  Hydraulic       
                                                         adjustable     
                                                         hospital bed.  
June 12, 1989....  54 FR 25042......  880.5120........  Manual          
                                                         adjustable     
                                                         hospital bed.  
Dec. 7, 1994.....  59 FR 63005......  880.5180........  Burn sheet.     
June 12, 1989....  54 FR 25042......  880.6280........  Medical insole. 
Oct. 21, 1980....  45 FR 69682......  880.6350........  Battery-powered 
                                                         medical        
                                                         examination    
                                                         light.         
June 12, 1989....  54 FR 25042......  880.6970........  Liquid crystal  
                                                         vein locator.  
------------------------------------------------------------------------

    Ten of the 56 devices listed in Table 4 are candidates for 
exemption from the requirement of premarket notification. These 
devices, which are listed in Table 7, along with the flotation cushion 
(Sec. 890.3175) and the traction accessory (Sec. 890.5925), are being 
proposed for premarket notification exemption elsewhere in today's 
issue of the Federal Register.

                                 Table 7                                
------------------------------------------------------------------------
               21 CFR                               Device              
------------------------------------------------------------------------
862.2230...........................  Chromatographic separation material
                                      for clinical use.                 
872.2230...........................  Dental floss (including devices    
                                      made of inert materials).         
874.1060...........................  Acoustic chamber for audiometric   
                                      testing.                          
874.4140...........................  Ear, nose, and throat bur.         
874.4175...........................  Nasopharyngeal catheter.           

[[Page 38899]]
                                                                        
874.4770...........................  Otoscope.                          
884.5150...........................  Nonpowered breast pump.            
884.5435...........................  Unscented menstrual pad.           
888.5960...........................  Cast removal instrument (AC        
                                      powered).                         
892.6500...........................  Personnel protective shield.       
------------------------------------------------------------------------



    For fifteen of the 56 devices listed in Table 8, FDA has concluded 
that these devices are not candidates for exemption from premarket 
notification procedures because they do not meet the criteria for 
exemption which is set out below.

                                 Table 8                                
------------------------------------------------------------------------
               21 CFR                               Device              
------------------------------------------------------------------------
862.2250...........................  Gas liquid chromatography system   
                                      for clinical use.                 
872.4200...........................  Dental handpiece and accessories.  
876.5160...........................  Urological clamp for males.        
876.5250...........................  Urine collector and accessories    
                                      (not connected to indwelling      
                                      catheter).                        
878.4040...........................  Surgical apparel (except surgical  
                                      gowns and masks).                 
878.4460...........................  Surgeon's gloves.                  
880.6250...........................  Patient examination glove.         
886.4370...........................  Keratome (AC powered).             
892.1300...........................  Nuclear rectilinear scanner.       
892.1320...........................  Nuclear uptake probe.              
892.1330...........................  Nuclear whole body scanner.        
892.1410...........................  Nuclear electrocardiograph         
                                      synchronizer.                     
892.1890...........................  Radiographic film illuminator.     
892.1910...........................  Radiographic grid.                 
892.1970...........................  Radiographic ECG/respirator        
                                      synchronizer.                     
------------------------------------------------------------------------

    As stated in the preamble of July 21, 1994, proposal, in order for 
devices to be exempted from the requirement of premarket notification, 
they must meet all of the following criteria: (1) The device does not 
have a significant history of false or misleading claims; (2) the 
device does not have a significant history of risk; (3) characteristics 
of the device necessary for its safe and effective performance are well 
established; (4) anticipated changes in the device that could affect 
safety and effectiveness will either: (a) be readily detectable by 
users by visual examination or other means or (b) not materially 
increase the risk of injury, incorrect diagnosis, or ineffective 
treatment; and (5) any changes in the device would not be likely to 
result in a change in the device's classification.
    The gas liquid chromatography system for clinical use 
(Sec. 862.2250); the urological clamp for males (Sec. 876.5160); and 
the urine collector and accessories (Sec. 876.5250) are class I, tier 2 
devices. As stated above, tier 2 devices require review of performance 
data because characteristics of these devices necessary for their safe 
and effective performance are not well established.
     Characteristics of the dental handpiece and accessories 
(Sec. 872.4200) and the nuclear rectilinear scanner (Sec. 892.1300), 
which are necessary for their safety and effective performance, are not 
well established. Moreover, anticipated changes in the devices that 
could affect safety and effectiveness are not readily detectable 
visually or by routine testing and could materially increase the risk 
of injury, incorrect diagnosis, or ineffective treatment.
    The keratome (Sec. 886.4370) is not a candidate for exemption from 
premarket notification because anticipated changes that could affect 
the safety and effectiveness of the device are not readily detectable 
visually or by routine testing.
    Surgical apparel (except surgical gowns and masks (Sec. 878.4040)) 
and surgeons's gloves (Sec. 878.4460) are not candidates for exemption 
from premarket notification procedures because anticipated changes that 
could affect safety and effectiveness are not readily detectable 
visually or by routine testing and could materially increase the risk 
of injury, namely the transmission of blood bourne pathogens.
    In the Federal Register of January 13, 1989 (53 FR 1604), the 
exemptions from premarket notification and current good manufacturing 
practices for patient examination gloves (Sec. 880.6250) were revoked 
because of the importance of this device in preventing the transmission 
between patients and health care workers of human immunodeficiency 
virus (HIV) that causes acquired immune deficiency syndrome (AIDS).
     The nuclear uptake probe (Sec. 892.1320); the nuclear 
electrocardiograph synchronizer (Sec. 892.1410); the nuclear whole body 
scanner (Sec. 892.1330); the radiographic film illuminator 
(Sec. 892.1890); the radiographic grid (Sec. 892.1910); and the 
radiographic ECG/respirator synchronizer (Sec. 892.1970) are not 
candidates for exemption from the requirement of premarket notification 
because anticipated changes that could affect the devices' safety and 
effectiveness are not readily detectable visually or by routine testing 
and could materially increase the risk of injury, incorrect diagnosis, 
or ineffective treatment.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

IV. Analysis of Impact

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this final rule reduces a regulatory burden 
by exempting manufacturers of devices subject to the final rule from 
the requirement of premarket notification, the agency certifies that 
the final rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.

List of Subjects in 21 CFR Parts 862 and 872

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
862 and 872 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

    1. The authority citation for 21 CFR part 862 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    2. Section 862.2310 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2310  Clinical sample concentrator.

 * * * * *

[[Page 38900]]

    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

    3. Section 862.2320 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2320  Beta or gamma counter for clinical use.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

    4. Section 862.2485 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2485  Electrophoresis apparatus for clinical use.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

    5. Section 862.2720 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2720  Plasma oncometer for clinical use.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

    6. Section 862.2800 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2800  Refractometer for clinical use.

* * * * *
     (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

    7. Section 862.2920 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2920  Plasma viscometer for clinical use.

* * * * *
     (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

PART 872--DENTAL DEVICES

    8. The authority citation for 21 CFR part 872 continues to read as 
follows:

     Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    9. Section 872.3740 is amended by revising paragraph (b) to read as 
follows:


Sec. 872.3740  Retentive and splinting pin.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

    10. Section 872.3810 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3810  Root canal post.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

    11. Section 872.6100 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6100  Anesthetic warmer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

    Dated: July 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-18458 Filed 7-27-95; 8:45 am]
BILLING CODE 4160-01-F