[Federal Register Volume 59, Number 139 (Thursday, July 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17705]


[[Page Unknown]]

[Federal Register: July 21, 1994]


_______________________________________________________________________

Part VI





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Part 862, et al.




Medical Devices; Proposed Exemptions From Premarket Notification for 
Certain Classified Devices; Proposed Rules




DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 
886, 888, 890, and 892

[Docket No. 94M-0260]

 
Medical Devices; Proposed Exemptions From Premarket Notification 
for Certain Classified Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to exempt 
164 generic types of class I devices from the requirement of premarket 
notification, with limitations. 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. Granting the exemptions will allow the agency to make better 
use of its resources and thus better serve the public.

DATES: Submit written comments by October 19, 1994. FDA is proposing 
that any final rule that may issue based on this proposed rule become 
effective 30 days after the date of its publication in the Federal 
Register.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4765.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Medical Device Amendments of 1976 (Pub. L. 94-295, hereinafter 
called the amendments) and the Safe Medical Devices Act of 1990 (the 
SMDA), establishes a comprehensive system for the regulation of medical 
devices intended for human use. Section 513 of the act (21 U.S.C. 360c) 
establishes three classes of devices, depending on the regulatory 
controls needed to provide reasonable assurance of their safety and 
effectiveness: Class I, general controls; class II, special controls; 
and class III, premarket approval.
    Section 513(d)(2)(A) of the act (21 U.S.C. 360c(d)(2)(A)) 
authorizes FDA to exempt, by regulation, a generic type of class I 
device from, among other things, the requirement of premarket 
notification in section 510(k) of the act (21 U.S.C. 360(k)). Such an 
exemption permits manufacturers to introduce into commercial 
distribution generic types of devices without first submitting a 
premarket notification to FDA. When FDA issued proposed regulations 
classifying preamendments devices, the agency focused on granting 
exemptions from the requirement of premarket notification principally 
when the advisory panels included them in their recommendations to the 
agency. Subsequently, FDA decided to exempt certain additional class I 
devices from the requirement of premarket notification in order to 
reduce the number of unnecessary premarket notifications. This action 
helped to free agency resources for the review of more complex 
notifications to FDA.
    Previously, FDA exempted 293 generic types of class I devices from 
the requirement of premarket notification, with limitations. Some of 
these devices were exempted from the requirement of premarket 
notification when the devices were initially classified into class I. 
However, the majority of these devices were exempted from the 
requirement of premarket notification after being classified into class 
I. These subsequent exemptions from the requirement of premarket 
notification appear in the following Federal Register publications (see 
Table 1).

                                                     Table 1                                                    
----------------------------------------------------------------------------------------------------------------
           Date             Federal Register citation           Type of device                No. of devices    
----------------------------------------------------------------------------------------------------------------
Aug. 25, 1987.............  52 FR 32110...............  Ear, Nose and Throat...........                        4
June 8, 1988..............  53 FR 21447...............  Clinical Chemistry and                                21
                                                         Toxicology.                                            
Sept. 14, 1988............  53 FR 35602...............  Ophthalmic.....................                       55
Dec. 29, 1988.............  53 FR 52952...............  Orthopedic.....................                        7
Apr. 5, 1989..............  54 FR 13826...............  General and Plastic Surgery....                        8
Apr. 5, 1989..............  54 FR 13828...............  Dental.........................                       22
Apr. 5, 1989..............  54 FR 13831...............  Radiology......................                        4
June 12, 1989.............  54 FR 25042...............  Hematology and Pathology.......                       24
                                                        Immunology and Microbiology....                       37
                                                        Anesthesiology.................                       13
                                                        Cardiovascular.................                        3
                                                        Gastroenterology and Urology...                        9
                                                        General Hospital and Personal                          6
                                                         Use.                                                   
                                                        Neurological...................                        7
                                                        Obstetrical and Gynecological..                        3
                                                        Physical Medicine..............                        2
----------------------------------------------------------------------------------------------------------------

II. Description of Proposed Exemptions

    In considering whether to exempt additional class I devices from 
premarket notification, FDA focused on whether notification for the 
type of device is unnecessary for the protection of the public health. 
For the devices proposed in this document to be exempted from premarket 
notification, FDA has concluded that notification is unnecessary 
primarily for the following reasons:
    (1) The device does not have a significant history of false or 
misleading claims or of risks associated with inherent characteristics 
of the device, such as device design or materials. When making these 
determinations, FDA generally has considered the frequency, 
persistence, cause, or seriousness of such claims or risks, as well as 
other factors deemed relevant.
    (2) In general, the following factors apply: (a) Characteristics of 
the device necessary for its safe and effective performance are well 
established; (b) anticipated changes in the device that could affect 
safety and effectiveness will either: (i) Be readily detectable by 
users by visual examination or other means, such as routine testing, 
before causing harm, e.g., testing of a clinical laboratory reagent 
with positive and negative controls; or (ii) not materially increase 
the risk of injury, incorrect diagnosis, or ineffective treatment; and 
(c) any changes in the device would not be likely to result in a change 
in the device's classification.
    FDA has made the determinations described above based on its 
knowledge of the device, including past experience and relevant reports 
or studies on device performance. If FDA has concerns only about 
certain types of changes to a particular class I device, the agency may 
grant a limited exemption from premarket notification for that generic 
type of device. A limited exemption will specify the types of changes 
to the device for which manufacturers are required to submit a 
premarket notification. For example, FDA may exempt a device from the 
requirement of premarket notification except when a manufacturer 
intends to use a different material.
    FDA advises manufacturers that an exemption from the requirement of 
premarket notification is not an exemption from any of the other 
general controls, including current good manufacturing practices 
(CGMP's), unless explicitly stated. Indeed, FDA's decision to propose 
510(k) exemptions for these devices is based, in part, on the fact that 
compliance with CGMP's will help insure product quality.
    FDA's decision to grant an exemption from the requirement of 
premarket notification for a generic type of class I device will be 
based upon the existing and reasonably foreseeable characteristics of 
commercially distributed devices within that generic type. Because FDA 
cannot anticipate every change or modification of a class I device 
exempt from premarket notification requirements that could 
significantly affect the safety or effectiveness, manufacturers of any 
commercially distributed class I device for which FDA has granted an 
exemption from the requirement of premarket notification are still 
required to submit a premarket notification to FDA before introducing a 
device or delivering it for introduction into interstate commerce for 
commercial distribution when:
    (1) The device is intended for a use different from its intended 
use before May 28, 1976, or the device is intended for a use different 
from the intended use of the preamendments device to which it has been 
determined to be substantially equivalent; e.g., the device is intended 
for a different medical purpose, or the device is intended for lay use 
instead of use by health care professionals; or
    (2) The modified device operates using a different fundamental 
scientific technology than used by the device before May 28, 1976; 
e.g., a surgical instrument cuts tissue with a laser beam rather than 
with a sharpened metal blade, or an in vitro diagnostic device detects 
or identifies infectious agents by using a deoxyribonucleic acid (DNA) 
probe or nucleic acid hybridization technology rather than culture or 
immunoassay technology.
    Such changes or modifications to class I devices that are exempt 
from premarket notification would mean the exemption would no longer 
apply. Changes or modifications to devices that are not exempt from 
premarket notification requirements under any regulation must undergo a 
more comprehensive assessment to determine the impact of the change or 
modification on the device's safety and effectiveness. FDA intends to 
develop guidance clarifying when a change or modification to a device 
requires submission of a premarket notification as defined in 21 CFR 
807.81(a)(3).
    On the dates listed, FDA published final regulations classifying, 
among others, the devices listed below. When FDA classified these 
devices, the agency did not propose exempting them from the requirement 
of premarket notification. Based on the analysis described above, FDA 
has now determined that premarket notification with respect to the 
devices listed below is unnecessary for the protection of the public 
health and will not advance FDA's public health mission. This approach 
is consistent with the recommendation in the May 1993 report of the 
Subcommittee on Oversight and Investigations of the Committee on Energy 
and Commerce, U.S. House of Representatives, entitled ``Less Than the 
Sum of its Parts Reforms Needed in the Organization, Management, and 
Resources of The Food and Drug Administration's Center for Devices and 
Radiological Health.''
    Earlier this year, the Office of Device Evaluation undertook a risk 
assessment of all devices in order to ensure the proper allocation of 
resources in the review process. All of the class I devices listed 
below were placed in Tier I, the category of devices which have a 
minimal inherent risk and whose review focuses upon intended use. A 
number of class II devices were also included in the Tier I evaluation 
process. FDA intends to consider proposing exemptions from the 
requirement of premarket notification for these devices. In the near 
future, FDA believes that exempting these devices from premarket 
notification will allow the agency to better use its available 
resources to protect the public health.
    FDA is proposing to exempt from the requirement of premarket 
notification, with limitations, the 164 generic type of class I devices 
listed in Table 2 below:

                                                     Table 2                                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                 No. of devices 
      CFR part                                         Title                                     proposed to be 
                                                                                                     exempt     
----------------------------------------------------------------------------------------------------------------
862.................  Clinical Chemistry and Clinical Toxicology Devices; May 1, 1987 (52 FR                   7
                       16102).                                                                                  
864.................  Hematology and Pathology Devices; September 12, 1980 (45 FR 60576).....                  6
866.................  Immunology and Microbiology Devices; November 9, 1982 (47 FR 50814)....                  8
868.................  Anesthesiology Devices; July 16, 1982 (47 FR 33130)....................                  5
870.................  Cardiovascular Devices; February 5, 1980 (45 FR 7904)..................                  1
872.................  Dental Devices; August 12, 1987 (52 FR 30082); November 20, 1990 (55 FR                 38
                       48436).                                                                                  
874.................  Ear, Nose and Throat Devices; November 6, 1986 (51 FR 40378)...........                  4
876.................  Gastroenterology-Urology Devices; November 23, 1983 (48 FR 53012)......                  1
878.................  General and Plastic Surgery Devices; June 24, 1988 (53 FR 23856).......                 16
880.................  General Hospital and Personal Use Devices; October 21, 1980 (45 FR                      13
                       69678).                                                                                  
882.................  Neurological Devices; September 4, 1979 (44 FR 51726)..................                 14
886.................  Ophthalmic Devices; September 2, 1987 (52 FR 33346)....................                 36
888.................  Orthopedic Devices; September 4, 1987 (52 FR 33686)....................                  5
890.................  Physical Medicine Devices; November 23, 1983 (48 FR 53032).............                  6
892.................  Radiology Devices; January 20, 1988 (53 FR 1554).......................                  4
                                                                                              ------------------
      Total.........  .......................................................................                164
----------------------------------------------------------------------------------------------------------------


      Table 3.--Clinical Chemistry and Clinical Toxicology Devices      
------------------------------------------------------------------------
              Section                              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. 
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 3 above. 
However, the proposed exemptions for the clinical sample concentrator 
(Sec. 862.2310), the beta or gamma counter for clinical use 
(Sec. 862.2320), the electrophoresis apparatus for clinical use 
(Sec. 862.2485), the plasma oncometer for clinical use (Sec. 862.2720), 
the refractometer for clinical use (Sec. 862.2800), and the plasma 
viscometer for clinical use (Sec. 862.2920) are limited and would apply 
only to those products intended for general use, which make no specific 
claims, and which include submissions containing a certified statement 
that the requirements for labeling of in vitro diagnostic products 
contained in 21 CFR 809.10 will be followed. 

               Table 4.--Hematology and Pathology Devices               
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
864.2280..........................  Cultured animal and human cells.    
864.5350..........................  Microsedimentation centrifuge.      
864.7660..........................  Leukocyte alkaline phosphate test.  
864.7675..........................  Leukocyte peroxidase test.          
864.7900..........................  Thromboplastin generation test.     
864.8500..........................  Lymphocyte separation medium.       
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 4 above. 

              Table 5.--Immunology and Microbiology Devices             
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
866.5170..........................  Breast milk immunological test      
                                     system.                            
866.5220..........................  Cohn fraction II immunological test 
                                     system.                            
866.5230..........................  Colostrum immunological test system.
866.5360..........................  Cohn fraction IV immunological test 
                                     system.                            
866.5370..........................  Cohn fraction V immunological test  
                                     system.                            
866.5540..........................  Immunoglobulin G (Fd fragment       
                                     specific) immunological test       
                                     system.                            
866.5570..........................  Lactoferrin immunological test      
                                     system.                            
866.5700..........................  Whole human plasma of serum         
                                     immunological test system.         
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 5 above. 

                    Table 6.--Anesthesiology Devices                    
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
868.5340..........................  Nasal oxygen cannula.               
868.5350..........................  Nasal oxygen catheter.              
868.5620..........................  Breathing mouthpiece.               
868.5675..........................  Rebreathing device.                 
868.5700..........................  Nonpowered oxygen tent.             
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 6 above. 

                    Table 7.--Cardiovascular Devices                    
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
870.1875..........................  Stethoscope.                        
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for the device in Table 7 above. However, this 
proposed exemption is limited and would apply only to the mechanical 
stethoscope, the manual stethoscope, and the direct (acoustic) 
stethoscope.

                        Table 8.--Dental Devices                        
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
872.1500..........................  Gingival fluid measurer.            
872.1820..........................  Dental X-Ray exposure alignment     
                                     device.                            
872.3100..........................  Dental amalgamator.                 
872.3130..........................  Preformed anchor.                   
872.3165..........................  Precision attachment.               
872.3240..........................  Dental burr.                        
872.3285..........................  Preformed clasp.                    
872.3330..........................  Preformed crown.                    
872.3350..........................  Gold or stainless steel cusp.       
872.3360..........................  Preformed cusp.                     
872.3410..........................  Ethylene oxide homopolymer and/or   
                                     carboxymethylcellulose sodium      
                                     denture adhesive.                  
872.3450..........................  Ethylene oxide homopolymer and/or   
                                     karaya adhesive.                   
872.3490..........................  Carboxymethylcellulose sodium and/or
                                     polyvinylmethylether maleic acid   
                                     calcium-sodium double salt denture 
                                     adhesive.                          
872.3520..........................  OTC denture cleanser.               
872.3530..........................  Mechanical dental cleaner.          
872.3580..........................  Preformed gold denture tooth.       
872.3670..........................  Resin impression tray material.     
872.3740..........................  Retentive and splinting pin.        
872.3810..........................  Root canal post.                    
872.3900..........................  Posterior artificial tooth with a   
                                     metal insert.                      
872.3910..........................  Backing and facing for an artificial
                                     tooth.                             
872.4130..........................  Intraoral dental drill.             
872.4535..........................  Dental diamond instrument.          
872.4620..........................  Fiber optic dental light.           
872.4730..........................  Dental injecting needle.            
872.5410..........................  Orthodontic appliances and          
                                     accessories.                       
872.5525..........................  Preformed tooth positioner.         
872.5550..........................  Solid teething ring (CPSC regulates 
                                     if no medical claims).             
872.6030..........................  Oral cavity abrasive polishing      
                                     agent.                             
872.6100..........................  Anesthetic warmer.                  
872.6140..........................  Articulation paper.                 
872.6250..........................  Dental chair and accessories.       
872.6300..........................  Rubber dam and accessories.         
872.6475..........................  Heat source for bleaching teeth.    
872.6510..........................  Oral irrigation unit.               
872.6640..........................  Dental operative unit and           
                                     accessories.                       
872.6865..........................  Powered toothbrush.                 
872.6890..........................  Intraoral dental wax.               
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 8 above. The 
proposed exemption for the dental chair and accessories (Sec. 872.6250) 
is limited and would apply only to products not containing an operative 
unit. The proposed exemption for the rubber dam and accessories 
(Sec. 872.6300) is also limited and would apply only to the 
accessories, i.e., the rubber dam clamp, the rubber dam frame and 
forceps for the clamp. Finally, the proposed exemption for the dental 
operative unit and accessories (Sec. 872.6640) is limited and would 
apply only to the accessories tray to the dental operative unit. 

                 Table 9.--Ear, Nose, and Throat Devices                
------------------------------------------------------------------------
             Section                               Device               
------------------------------------------------------------------------
874.3375..........................  Battery-powered artificial larynx.  
874.4750..........................  Laryngostroboscope.                 
874.5220..........................  Ear, nose, and throat drug          
                                     administration device.             
874.5800..........................  External nasal splint.              
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 9 above. 

               Table 10.--Gastroenterology-Urology Devices              
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
876.5970..........................  Hernia support.                     
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for the device in Table 10 above. 

             Table 11.--General and Plastic Surgery Devices             
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
878.1800..........................  Speculum and accessories.           
878.3750..........................  External prosthesis adhesive.       
878.3800..........................  External aesthetic restoration      
                                     prosthesis.                        
878.3900..........................  Inflatable extremity splint.        
878.4100..........................  Organ bag.                          
878.4380..........................  Drape adhesive.                     
878.4440..........................  Eye pad.                            
878.4470..........................  Surgeon's gloving cream.            
878.4635..........................  Ultraviolet lamp for tanning.       
878.4660..........................  Skin marker.                        
878.4700..........................  Surgical microscope and accessories.
878.4730..........................  Surgical skin degreaser/adhesive    
                                     solvent.                           
878.4800..........................  Manual surgical instrument for      
                                     general use.                       
878.4930..........................  Suture retention device.            
878.4950..........................  Manual operating table and          
                                     accessories and manual operating   
                                     chair and accessories.             
878.5900..........................  Non-pneumatic tourniquet.           
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 11 above. 
However, the proposed exemption for the organ bag (Sec. 878.4100) is 
limited and would apply only to intestinal organ bags.

          Table 12.--General Hospital and Personal Use Devices          
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
880.2400..........................  Bed patient monitor.                
880.2720..........................  Patient scale.                      
880.5180..........................  Burn sheet.                         
880.5210..........................  Intravascular catheter securement   
                                     device.                            
880.5240..........................  Medical adhesive tape and adhesive  
                                     bandage.                           
880.5630..........................  Nipple shield.                      
880.5740..........................  Suction snakebite kit.              
880.5780..........................  Medical support stocking            
880.5950..........................  Umbilical occlusion device.         
880.6060..........................  Medical disposable bedding.         
880.6150..........................  Ultrasonic cleaner for medical      
                                     instruments.                       
880.6190..........................  Mattress cover for medical purposes.
880.6900..........................  Hand-carried stretcher.             
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 12 above. 

                    Table 13.--Neurological Devices                     
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
882.1430..........................  Electroencephalograph test signal   
                                     generator.                         
882.1700..........................  Percussor.                          
882.1925..........................  Ultrasonic scanner calibration test 
                                     block.                             
882.4030..........................  Skull plate anvil.                  
882.4125..........................  Neurosurgical chair.                
882.4190..........................  Clip forming/cutting instrument.    
882.4200..........................  Clip removal instrument.            
882.4215..........................  Clip rack.                          
882.4440..........................  Neurosurgical headrest.             
882.4500..........................  Cranioplasty material forming       
                                     instrument.                        
882.4525..........................  Microsurgical instrument.           
882.4535..........................  Nonpowered neurosurgical instrument.
882.4600..........................  Leukotome.                          
882.4900..........................  Skullplate screwdriver.             
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 13 above. 

                     Table 14.--Ophthalmic Devices                      
------------------------------------------------------------------------
              Section                              Device               
------------------------------------------------------------------------
886.1040..........................  Ocular esthesiometer.               
886.1050..........................  Adaptometer (biophotometer).        
886.1070..........................  Anomaloscope.                       
886.1090..........................  Haidlinger brush.                   
886.1140..........................  Ophthalmic chair.                   
886.1160..........................  Color vision plate illuminator.     
886.1250..........................  Euthyscope.                         
886.1290..........................  Fixation device.                    
886.1340..........................  Haploscope.                         
886.1350..........................  Keratoscope.                        
886.1425..........................  Lens measuring instrument.          
886.1430..........................  Ophthalmic contact lens radius      
                                     measuring device.                  
886.1435..........................  Maxwell spot.                       
886.1450..........................  Corneal radius measuring device.    
886.1660..........................  Gonioscopic prism.                  
886.1680..........................  Ophthalmic projector.               
886.1690..........................  Pupillograph.                       
886.1700..........................  Pupillometer.                       
886.1810..........................  Tangent screen (campimeter).        
886.1860..........................  Ophthalmic instrument stand.        
886.1870..........................  Stereoscope.                        
886.1910..........................  Spectacle dissociation test system. 
886.1945..........................  Transilluminator.                   
886.4250..........................  Ophthalmic electrolysis unit.       
886.4350..........................  Manual ophthalmic surgical          
                                     instrument.                        
886.4360..........................  Ocular surgery irrigation device.   
886.4570..........................  Ophthalmic surgical marker.         
886.4750..........................  Ophthalmic eye shield.              
886.4855..........................  Ophthalmic instrument table.        
886.5820..........................  Closed-circuit television reading   
                                     system.                            
886.5840..........................  Magnifying spectacles.              
886.5842..........................  Spectacle frame.                    
886.5844..........................  Prescription spectacle lens.        
886.5850..........................  Sunglasses (nonprescription).       
886.5900..........................  Electronic vision aid.              
886.5915..........................  Optical vision aid.                 
------------------------------------------------------------------------

    FDA is proposing to grant exemption from the requirement of 
premarket notification for each of the devices in Table 14 above. The 
proposed exemption for the keratoscope (Sec. 886.1350) and for the 
corneal radius measuring device (Sec. 886.1450) is limited and does not 
include topographers. Additionally, the proposed exemption for the 
ophthalmic chair (Sec. 886.1140), keratoscope (Sec. 886.1350), 
pupillometer (Sec. 886.1700), tangent screen (Sec. 886.1810), 
ophthalmic instrument stand (Sec. 886.1860), stereoscope 
(Sec. 886.1870), spectacle dissociation test system (Sec. 886.1910), 
ophthalmic instrument table (Sec. 886.4855), and optical vision aid 
(Sec. 886.5915) would apply to alternating current (AC)-powered 
devices. The proposed exemption for nonprescription sunglasses 
(Sec. 886.5850) is limited and applies only to sunglasses which: (1) 
Transmit less than 1.0 percent UV-B radiation, (2) transmit less than 
5.0 percent UV-A radiation, (3) meet impact resistance (21 CFR 
801.410), (4) are made with nonflammable materials, and (5) limit 
claims to reduction of the risk of age-related cataracts, and/or 
photokeratitis. The proposed exemption for the euthyscope 
(Sec. 886.1250), transilluminator (Sec. 886.1945) and ophthalmic 
electrolysis unit (Sec. 886.4250) is limited and would apply only to 
battery-powered devices (AC-powered devices are class II devices). 

                     Table 15.--Orthopedic Devices                      
------------------------------------------------------------------------
             Section                               Device               
------------------------------------------------------------------------
888.4200..........................  Cement dispenser.                   
888.4210..........................  Cement mixer for clinical use.      
888.4230..........................  Cement ventilation tube.            
888.4540..........................  Orthopedic manual surgical          
                                     instrument.                        
888.5940..........................  Cast components.                    
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 15 above. 

                  Table 16.--Physical Medicine Devices                  
------------------------------------------------------------------------
             Section                               Device               
------------------------------------------------------------------------
890.1175..........................  Electrode cable.                    
890.3100..........................  Mechanical chair.                   
890.3750..........................  Mechanical table.                   
890.3920..........................  Wheelchair component.               
890.3940..........................  Wheelchair platform scale.          
890.5765..........................  Pressure-applying device.           
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 16 above. 

                      Table 17.--Radiology Devices                      
------------------------------------------------------------------------
             Section                               Device               
------------------------------------------------------------------------
892.1130..........................  Nuclear whole body counter.         
892.1350..........................  Nuclear scanning bed.               
892.1640..........................  Radiographic film marking system.   
892.5740..........................  Radionuclide teletherapy source.    
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 17 above. The 
proposed exemption for the nuclear scanning bed (Sec. 892.1350) is 
limited and would apply only if the device is labeled with weight 
limit, is used with planar scanning only, and is not for diagnostic X-
ray use.

III. Environmental Impact

    The agency has determined under 21 CFR 25.249(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 Impacts

    FDA has examined the impacts of the proposed 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 proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
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 
proposal on small entities. Because this proposal would reduce a 
regulatory burden by exempting manufacturers of devices subject to the 
rule from the requirements of premarket notification, the agency 
certifies that the proposed 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.

V. Request for Comments

    Interested persons may, on or before October 19, 1994, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects

21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 888, and 890

    Medical devices.

21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 
880, 882, 886, 888, 890, and 892 be 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 862.2270 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2270  Thin-layer chromatography system 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. Particular components of TLC systems, i.e., the thin-layer 
chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC 
ultraviolet light, are also exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    3. Section 862.2310 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2310  Clinical sample concentrator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter only when the products are intended for general use, make no 
specific claims, and only if labeling follows the format in Sec. 809.10 
of this chapter.
    4. Section 862.2320 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2320  Beta and 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 only when the products are intended for general use, make no 
specific claims, and only if labeling follows the format in Sec. 809.10 
of this chapter.
    5. 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 only when the products are intended for general use, make no 
specific claims, and only if labeling follows the format in Sec. 809.10 
of this chapter.
    6. 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 only when the products are intended for general use, make no 
specific claims, and only if labeling follows the format in Sec. 809.10 
of this chapter.
    7. 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 only when the products are intended for general use, make no 
specific claims, and only if labeling follows the format in Sec. 809.10 
of this chapter.
    8. 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 only when the products are intended for general use, make no 
specific claims, and only if labeling follows the format in Sec. 809.10 
of this chapter.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    9. The authority citation for 21 CFR part 864 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).

    10. Section 864.2280 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2280  Cultured animal and human cells.

* * * * *
    (b) Classification. Class I. The devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    11. Section 864.5350 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.5350  Microsedimentation centrifuge.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    12. Section 864.7660 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.7660  Leukocyte alkaline phosphatase test.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    13. Section 864.7675 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.7675  Leukocyte peroxidase test.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    14. Section 864.7900 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.7900  Thromboplastin generation test.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    15. Section 864.8500 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.8500  Lymphocyte separation medium.

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

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    16. The authority citation for 21 CFR part 866 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).

    17. Section 866.5170 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5170  Breast milk immunological test system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    18. Section 866.5220 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5220  Cohn fraction II immunological test system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    19. Section 866.5230 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5230  Colostrum immunological test system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    20. Section 866.5360 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5360  Cohn fraction IV immunological test system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    21. Section 866.5370 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5370  Cohn fraction V immunological test system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    22. Section 866.5540 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5540  Immunoglobin G (Fd fragment specific) immunological test 
system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    23. Section 866.5570 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5570  Lactoferrin immunological test system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    24. Section 866.5700 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5700  Whole human plasma of serum immunological test system.

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

PART 868--ANESTHESIOLOGY DEVICES

    25. The authority citation for 21 CFR part 868 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).

    26. Section 868.5340 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5340  Nasal oxygen cannula.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    27. Section 868.5350 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5350  Nasal oxygen catheter.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    28. Section 868.5620 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5620  Breathing mouthpiece.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    29. Section 868.5675 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5675  Rebreathing device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    30. Section 868.5700 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5700  Nonpowered oxygen tent.

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

PART 870--CARDIOVASCULAR DEVICES

    31. The authority citation for 21 CFR part 870 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).

    32. Section 870.1875 is amended by revising paragraph (a)(2) to 
read as follows:


Sec. 870.1875  Stethoscope.

    (a) * * *
    (2) Classification. Class I. The mechanical stethoscope, the manual 
stethoscope and the direct (acoustic) stethoscope are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
* * * * *

PART 872--DENTAL DEVICES

    33. 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).

    34. Section 872.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1500  Gingival fluid measurer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    35. Section 872.1820 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1820  Dental X-ray exposure alignment device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    36. Section 872.3100 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3100  Dental amalgamator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    37. Section 872.3130 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3130  Preformed anchor.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    38. Section 872.3165 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3165  Precision attachment.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    39. Section 872.3240 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3240  Dental bur.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807.
    40. Section 872.3285 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3285  Preformed clasp.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    41. Section 872.3330 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3330  Preformed crown.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    42. Section 872.3350 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3350  Gold or stainless steel cusp.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    43. Section 872.3360 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3360  Preformed cusp.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    44. Section 872.3410 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3410  Ethylene oxide homopolymer and/or carboxymethylcellulose 
sodium denture adhesive.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    45. Section 872.3450 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3450  Ethylene oxide homopolymer and/or karaya adhesive.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    46. Section 872.3490 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3490  Carboxymethylcellulose sodium and/or 
polyvinylmethylether maleic acid calcium-sodium double salt denture 
adhesive.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    47. Section 872.3520 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3520  OTC denture cleanser.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    48. Section 872.3530 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3530  Mechanical dental cleaner.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    49. Section 872.3580 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3580  Preformed gold denture tooth.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    50. Section 872.3670 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3670  Resin impression tray material.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    51. 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.
    52. 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.
    53. Section 872.3900 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3900  Posterior artificial tooth with a metal insert.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    54. Section 872.3910 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3910  Backing and facing for an artificial tooth.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    55. Section 872.4130 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4130  Intraoral dental drill.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    56. Section 872.4535 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4535  Dental diamond instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    57. Section 872.4620 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4620 Fiber optic dental light.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    58. Section 872.4730 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4730  Dental injecting needle.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    59. Section 872.5410 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.5410  Orthodontic appliance and accessories.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    60. Section 872.5525 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.5525  Preformed tooth positioner.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    61. Section 872.5550 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 872.5550  Teething ring.

* * * * *
    (b)(1) Classification. Class I if the teething ring does not 
contain a fluid, such as water. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
* * * * *
    62. Section 872.6030 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6030  Oral cavity abrasive polishing agent.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    63. 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.
    64. Section 872.6140 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6140  Articulation paper.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    65. Section 872.6250 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6250  Dental chair and accessories.

* * * * *
    (b) Classification. Class I. The dental chair without the operative 
unit device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter.
    66. Section 872.6300 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6300  Rubber dam and accessories.

* * * * *
    (b) Classification. Class I. The accessories to the device, i.e., 
rubber dam clamp, rubber dam frame and forceps for a rubber dam clamp, 
are exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter. If the device is not labeled or otherwise 
represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.
    67. Section 872.6475 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6475  Heat source for bleaching teeth.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    68. Section 872.6510 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6510  Oral irrigation unit.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    69. Section 872.6640 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6640  Dental operative unit and accessories.

* * * * *
    (b) Classification. Class I. The accessories tray to the dental 
operative unit is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter.
    70. Section 872.6865 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6865  Powered toothbrush.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    71. Section 872.6890 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6890  Intraoral dental wax.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

PART 874--EAR, NOSE, AND THROAT DEVICES

    72. The authority citation for 21 CFR part 874 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).

    73. Section 874.3375 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.3375  Battery-powered artificial larynx.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    74. Section 874.4750 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4750  Laryngostroboscope.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    75. Section 874.5220 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5220  Ear, nose, and throat drug administration device.

    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    76. Section 874.5800 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5800  External nasal splint.

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

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    77. The authority citation for 21 CFR part 876 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).

    78. Section 876.5970 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5970  Hernia support.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The device is exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    79. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 
360e, 360j, 3601, 371).

    80. Section 878.1800 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.1800  Speculum and accessories.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    81. Section 878.3750 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3750  External prosthesis adhesive.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    82. Section 878.3800 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3800  External aesthetic restoration prosthesis.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is intended for use without an external 
prosthesis adhesive to fasten it to the body, the device is exempt from 
the current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
    83. Section 878.3900 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3900  Inflatable extremity splint.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    84. Section 878.4100 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4100  Organ bag.

* * * * *
    (b) Classification. Class I. The intestinal organ bag device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter.
    85. Section 878.4380 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4380  Drape adhesive.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    86. Section 878.4440 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4440  Eye pad.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    87. Section 878.4470 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4470  Surgeon's gloving cream.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    88. Section 878.4635 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4635  Ultraviolet lamp for tanning.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    89. Section 878.4660 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4660  Skin marker.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    90. Section 878.4700 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4700  Surgical microscope and accessories.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    91. Section 878.4730 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4730  Surgical skin degreaser or adhesive tape solvent.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    92. Section 878.4800 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4800  Manual surgical instrument for general use.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    93. Section 878.4930 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4930  Suture retention device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    94. Section 878.4950 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4950  Manual operating table and accessories and manual 
operating chair and accessories.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    95. Section 878.5900 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.5900  Nonpneumatic tourniquet.

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

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    96. The authority citation for 21 CFR part 880 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).

    97. Section 880.2400 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.2400  Bed-patient monitor.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    98. Section 880.2720 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 880.2720  Patient scale.

* * * * *
    (b) Classification. (1) Class I for a mechanical or battery powered 
patient scale. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter.
    99. Section 880.5180 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5180  Burn sheet.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    100. Section 880.5210 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5210  Intravascular catheter securement device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    101. Section 880.5240 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5240  Medical adhesive tape and adhesive bandage.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    102. Section 880.5630 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5630 Nipple shield.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    103. Section 880.5740 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5740  Suction snakebite kit.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    104. Section 880.5780 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 880.5780  Medical support stocking.

* * * * *
    (b) * * *
    (2) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The device is exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    105. Section 880.5950 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5950  Umbilical occlusion device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    106. Section 880.6060 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6060  Medical disposable bedding.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    107. Section 880.6150 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6150  Ultrasonic cleaner for medical instruments.

* * * * *
    (b) Classification. Class I. The device, including any solutions 
intended for use with the device for cleaning and sanitizing the 
instruments, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter.
    108. Section 880.6190 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6190  Mattress cover for medical purposes.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    109. Section 880.6900 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6900  Hand-carried stretcher.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The device is exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

PART 882--NEUROLOGICAL DEVICES

    110. The authority citation for 21 CFR part 882 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).

    111. Section 882.1430 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1430  Electroencephalograph test signal generator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    112. Section 882.1700 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1700  Percussor.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The device is also exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    113. Section 882.1925 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1925  Ultrasonic scanner calibration test block.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    114. Section 882.4030 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4030  Skull plate anvil.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    115. Section 882.4125 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4125  Neurosurgical chair.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    116. Section 882.4190 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4190  Clip forming/cutting instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    117. Section 882.4200 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4200  Clip removal instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    118. Section 882.4215 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4215  Clip rack.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    119. Section 882.4440 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4440  Neurosurgical headrest.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    120. Section 882.4500 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4500  Cranioplasty material forming instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    121. Section 882.4525 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4525  Microsurgical instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    122. Section 882.4535 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4535  Nonpowered neurosurgical instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    123. Section 882.4600 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4600  Leukotome.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    124. Section 882.4900 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4900  Skullplate screwdriver.

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

PART 886--OPHTHALMIC DEVICES

    125. The authority citation for 21 CFR part 886 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).

    126. Section 886.1040 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1040  Ocular esthesiometer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    127. Section 886.1050 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1050  Adaptometer (biophotometer).

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    128. Section 886.1070 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1070  Anomaloscope.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    129. Section 886.1090 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1090  Haidlinger brush.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    130. Section 886.1140 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1140  Ophthalmic chair.

* * * * *
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from 
the current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
    131. Section 886.1160 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1160  Color vision plate illuminator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    132. Section 886.1250 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1250  Euthyscope.

* * * * *
    (b) Classification. Class I for the battery powered device. The 
battery powered device is exempt from premarket notification procedures 
in subpart E of part 807 of this chapter. Class II for the AC-powered 
device.
    133. Section 886.1290 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1290  Fixation device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    134. Section 886.1340 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1340  Haploscope.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    135. Section 886.1350 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1350  Keratoscope.

* * * * *
    (b) Classification. Class I. The AC-powered device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter only when the device does not include computer software in the 
unit or topographers. The battery-powered device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The battery-powered device is also exempt from the current 
good manufacturing practice regulations in part 820 of this chapter, 
with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
    136. Section 886.1425 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1425  Lens measuring instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    137. Section 886.1430 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1430  Ophthalmic contact lens radius measuring device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    138. Section 886.1435 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1435  Maxwell spot.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    139. Section 886.1450 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1450  Corneal radius measuring device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter only when the device does not include computer software in the 
unit or topographers.
    140. Section 886.1660 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1660  Gonioscopic prism.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    141. Section 886.1680 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1680  Ophthalmic projector.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    142. Section 886.1690 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1690  Pupillograph.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    143. Section 886.1700 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1700  Pupillometer.

* * * * *
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from 
the current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
    144. Section 886.1810 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1810  Tangent screen (campimeter).

* * * * *
    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    145. Section 886.1860 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1860 Ophthalmic instrument stand.

    (b) Classification. Class I. The AC-powered device and the battery-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    146. Section 886.1870 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1870  Stereoscope.

* * * * *
    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    147. Section 886.1910 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1910  Spectacle dissociation test system.

* * * * *
    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    148. Section 886.1945 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1945  Transilluminator.

* * * * *
    (b) Classification. Class I for the battery-powered device. Class 
II for the AC-powered device. The battery-powered Class I device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter.
    149. Section 886.4250 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4250  Ophthalmic electrolysis unit.

* * * * *
    (b) Classification. Class I for the battery-powered device. Class 
II for the AC-powered device. The battery-powered Class I device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter.
    150. Section 886.4350 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4350  Manual ophthalmic surgical instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    151. Section 886.4360 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4360  Ocular surgery irrigation device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    152. Section 886.4570 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4570  Ophthalmic surgical marker.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    153. Section 886.4750 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4750  Ophthalmic eye shield.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The device also is exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    154. Section 886.4855 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4855  Ophthalmic instrument table.

* * * * *
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from 
the current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
    155. Section 886.5820 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5820  Closed-circuit television reading system.

* * * * *
    (b) Classification. Class I. The AC-powered device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter.
    156. Section 886.5840 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5840  Magnifying spectacles.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    157. Section 886.5842 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5842  Spectacle frame.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    158. Section 886.5844 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5844  Prescription spectacle lens.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    159. Section 886.5850 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5850  Sunglasses (nonprescription).

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter and the exemption applies only to sunglasses which:
    (1) Transmit less than 1.0 percent UV-B radiation;
    (2) Transmit less than 5.0 percent UV-A radiation;
    (3) Meet impact resistance (21 CFR 801.410);
    (4) Use nonflammable materials; and
    (5) Limit claims to reduction of the risk age-related cataracts 
and/or photokeratitis.
    160. Section 886.5900 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5900  Electronic vision aid.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    161. Section 886.5915 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5915  Optical vision aid.

* * * * *
    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

PART 888--ORTHOPEDIC DEVICES

    162. The authority citation for 21 CFR part 888 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).

    163. Section 888.4200 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4200  Cement dispenser.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    164. Section 888.4210 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4210  Cement mixer 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.
    165. Section 888.4230 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4230  Cement ventilation tube.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    166. Section 888.4540 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4540  Orthopedic manual surgical instrument.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    167. Section 888.5940 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.5940  Cast component.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The device is also exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.

PART 890--PHYSICAL MEDICINE DEVICES

    168. The authority citation for 21 CFR part 890 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).

    169. Section 890.1175 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1175  Electrode cable.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The devices are also exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.
    170. Section 890.3100 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3100  Mechanical chair.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    171. Section 890.3750 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3750  Mechanical table.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    172. Section 890.3920 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3920  Wheelchair component.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    173. Section 890.3940 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3940  Wheelchair platform scale.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The device is also exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    174. Section 890.5765 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5765  Pressure-applying device.

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

PART 892--RADIOLOGY DEVICES

    175. The authority citation for 21 CFR part 892 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).

    176. Section 892.1130 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1130  Nuclear whole body counter.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    177. Section 892.1350 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1350  Nuclear scanning bed.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter only when the device is labeled with weight limit, is used with 
planar scanning only, and is not for diagnostic X-ray use.
    178. Section 892.1640 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1640  Radiographic film marking system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    179. Section 892.5740 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.5740  Radionuclide teletherapy source.

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

    Dated: July 15, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-17705 Filed 7-18-94; 11:43 am]
BILLING CODE 4160-01-P