[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Proposed Rules]
[Pages 38902-38916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18456]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 862, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 
886, 888, 890, and 892

[Docket No. 95N-0139]


Medical Devices; Proposed Reclassification and Exemption 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 
reclassify 112 generic types of class II devices into class I based on 
new information respecting such devices. FDA is also proposing to 
exempt the 112 generic types of devices, and 12 already classified 
generic types of class I devices, from the requirement of premarket 
notification, with limitations. For the devices for which exemptions 
are being proposed, 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 11, 1995. For the devices the 
agency is proposing to reclassify into class I and exempt from the 
requirement of premarket notification, FDA is proposing that any final 
rule that may issue based on this proposed rule become effective August 
28, 1995.

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: Melpomeni K. Jeffries, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2186.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 
et. seq.), as amended by the Medical Devices 

[[Page 38903]]
Amendments of 1976 (Pub. L. 94-295, hereinafter called the amendments) 
and the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629), 
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.
    The effect of classifying a device into class I is to require that 
the device meet only the general controls which are applicable to all 
devices. Two types of devices are classified into class I. The first 
type of class I device is comprised of those devices for which general 
controls are sufficient to provide reasonable assurance of the safety 
and effectiveness of the devices (section 513(a)(1)(A)(i) of the act). 
The second type of class I device consists of those devices for which 
insufficient information exists to determine that general controls are 
sufficient to provide reasonable assurance of the safety and 
effectiveness of the device * * * but are not purported or represented 
to be for a use in supporting or sustaining human life or for a use 
which is of substantial importance in preventing impairment of human 
health and do not present a potential unreasonable risk of illness or 
injury (section 513(a)(1)(A)(ii) of the act). A ``potential 
unreasonable risk of illness or injury'' includes actual risk, as well 
as potential risk. Thus, the risk may be one demonstrated by reported 
injuries; i.e., medical device reports (MDR's), or it may simply be 
foreseeable. See H. Rept. 853, 94th Cong., 2d. sess. 36 (1990).
    The effect of classifying a device into class II is to require the 
device to meet general controls as well as special controls, which 
together provide reasonable assurance of the safety and effectiveness 
of the device. Class II devices include devices which cannot be 
classified in class I because general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness and for which there is sufficient information to 
establish special controls to provide such assurance, including the 
promulgation of performance standards (see section 513(a)(1)(B) of the 
act).
    The effect of classifying a device into class III is to require 
each manufacturer of the device to submit to FDA a premarket approval 
application (PMA) that includes information concerning safety and 
effectiveness of the device.

II. Reclassification Criteria

    Pursuant to section 513(e)(1) of the act, based on new information 
respecting a device, the agency may, upon its own initiative, by 
regulation change a device's classification and revoke, because of the 
change in classification, any regulation or requirement in effect with 
respect to such device under sections 514 or 515 of the act (21 U.S.C. 
360d or 21 U.S.C. 360e). The new information respecting a device must 
demonstrate that either more regulatory control is needed to provide 
reasonable assurance of the device's safety and effectiveness or that 
less regulatory control is sufficient to provide such assurance. The 
following developments have produced new information relating to the 
devices which justifies reclassifying these devices.
A. The SMDA Provisions

    In the Federal Register of September 14, 1984 (49 FR 36326 at 
36348), FDA issued MDR regulations (21 CFR part 803). These regulations 
required manufacturers and importers of medical devices, including 
diagnostic devices, to report to FDA whenever the manufacturer or 
importer becomes aware of information that reasonably suggests that one 
of its marketed devices: (1) May have caused or contributed to a death 
or serious injury, or (2) has malfunctioned and that the device or any 
other device marketed by the manufacturer or importer would be likely 
to cause or contribute to a death or serious injury if the malfunction 
were to recur. Because these MDR regulations were not always adequate 
to protect the public health, the SMDA, which was signed into law on 
November 28, 1990, added the following MDR requirements and provisions, 
as well as other requirements and provisions:
    (1) Section 518(e) of the act (21 U.S.C. 360h(e)) allows FDA to 
order a manufacturer or other appropriate firm to immediately cease 
distribution of a device and immediately notify health professionals 
and device user facilities to cease using the device after FDA has 
determined that there is a reasonable probability that the device would 
cause serious adverse health consequences or death.
    (2) Section 519(a)(6) of the act (21 U.S.C. 360i(a)(6)) requires 
distributors of medical devices to report to FDA adverse experiences 
related to devices, and to submit copies of reports to device 
manufacturers.
    (3) Section 519(b)(1) of the act (21 U.S.C. 360i(b)(1)) requires 
certain device user facilities (hospitals, nursing homes, ambulatory 
surgical facilities, and outpatient treatment facilities which are not 
physician's offices) to report to FDA and the manufacturer, if known, 
deaths related to medical devices. Additionally, under this section, 
device user facilities are required to report to the manufacturer, or 
to FDA if the manufacturer is unknown, device-related serious illnesses 
or injuries. User facilities are also required to submit a semiannual 
report to FDA summarizing the reports they have submitted. Under this 
section, reporting is limited to events involving a facility's 
patients.
    (4) Section 519(d) of the act (21 U.S.C. 360e(d)) requires 
manufacturers, importers, and distributors to certify to FDA the number 
of reports submitted in a year or the fact that no such reports have 
been submitted to the agency.
    (5) Section 519(f) of the act (21 U.S.C. 360i(f)) requires 
manufacturers, importers, and distributors to report to FDA any 
removals or corrections of a device intended to reduce a risk to health 
posed by a device or to remedy a violation of the act which may present 
a risk to health.
    These new authorities, which are applicable to all devices, 
including class I devices, will enable FDA to monitor the 112 devices 
proposed for reclassification more closely and to take appropriate 
remedial action, if necessary.
B. The Device Priority Model

    Assuring the safety and effectiveness of all medical devices is an 
extremely complex and difficult task in light of the number and 
diversity of devices being marketed. Thus, in 1989, FDA's Office of 
Standards and Regulations established a Device Priority Model (DPM) to 
help set priorities for all medical device activities (Ref. 1).
    The DPM uses six general parameters, referred to as evaluation 
factors, to describe and calculate a priority score for each device. 
The six evaluation factors used in the model are: Frequency of 
mortality, effectiveness, health benefit, frequency of use, frequency 
of serious injury, and frequency of less serious injury.
    The values for these evaluation factors are combined linearly using 
weights which represent the relative societal importance of each 
evaluation factor. The evaluation factors and assigned model weights 
are as follows: Frequency of death .38, frequency of serious injury 
.30, frequency of less serious injury .12, frequency of use .08, health 
benefit .08, and effectiveness .04.
    After assigning model weights to the evaluation factors, a three 
level scoring scheme is applied. Predetermined 

[[Page 38904]]
ranges of the values of the evaluation factors were used to determine a 
high, medium, or low scoring level. For frequency of death, frequency 
of serious injury, and frequency of less serious injury, the 
correspondence between the estimates for evaluation factor values and 
evaluation factor scores are: High = 100, medium = 50, and low = 0. The 
corresponding evaluation factor values and evaluation factor scores for 
the remaining three evaluation factors (frequency of use, health 
benefit, and effectiveness) are reversed; low = 100, medium = 50, high 
= 0. The reason for this reversal is as follows: If one considers two 
devices that are associated with an equal annual incidence of deaths 
and injuries, the device that should have the highest priority for FDA 
action is the one with the highest intrinsic risk per use, the lowest 
health benefit, and the lowest effectiveness.
    The resulting number is called the priority score and is calculated 
by multiplying the score by the weight. The priority score is used to 
flag devices that may require more extensive analysis.

C. The Three Tier System

    In early 1994, FDA's Office of Device Evaluation undertook a risk 
assessment of all devices in order to ensure the proper allocation of 
resources for the review process. Under this risk assessment, all class 
I, class II, and class III devices were placed into one of three tiers 
based upon the inherent risk associated with each device. Tier 3 
devices include many first and second of a kind devices utilizing new 
technology or having new intended uses(s), as well as other devices 
determined by their inherent risk to require an intensive review. These 
tier 3 devices require intensive scientific and labeling review by a 
review team as well as advisory panel input. Most tier 3 devices 
require the submission of a premarket approval application. Tier 2 
devices include devices which require routine scientific and labeling 
review. This tier encompasses the majority of 510(k)'s and select 
PMA's. Tier 1 devices include devices which require only a focused 
labeling review for intended use/indications for use and devices which 
have: (1) A score in the DPM less than 30 and/or; (2) no MDR death 
reports in any of the previous 3 years; and (3) 10 or fewer total 
injury reports in the previous 3 years.

III. Class II Devices To Be Reclassified Into Class I

    The agency has carefully reviewed all available information 
concerning all class II, tier 1 devices. Based on this review, FDA is 
now proposing to reclassify 112 class II, tier 1 devices into class I. 
All of these devices were originally classified into class II under the 
original definition of class II devices which was defined as ``a device 
which cannot be classified as a class I because general controls by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness, for which there is sufficient information to 
establish a performance standard to provide such assurance, * * *.'' 
See H. Rept. 94-853, 94th Cong., 2d sess. 107 (1976). To date, no 
performance standards have been promulgated. Thus, any risks presented 
by these 112 devices have been addressed solely by general controls. 
The lack of adverse events or threats to the public health reported in 
the new information described above, supports agency's conclusion that 
general controls are adequate to provide reasonable assurance of safety 
and effectiveness for the 112 devices. In light of the new SMDA 
requirements, the new information gathered in response to the 
development of the DPM, and the three tier risk assessment system, FDA 
has determined that general controls will provide reasonable assurance 
of the safety and effectiveness of these devices.

IV. Proposed Exemptions

    Section 513(d)(2)(A) of the act 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. Moreover, in accordance with the agency's 
policy of reducing the number of unnecessary premarket notifications, 
in the Federal Register of December 7, 1994 (59 FR 63005), FDA exempted 
148 generic types of class I devices from the requirement of premarket 
notification, with limitations. These actions help to free agency 
resources for the review of more complex notifications to FDA.

A. 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 in this document, FDA has concluded that premarket 
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.
    For the 124 devices, FDA has made the determinations described 
above based on its knowledge of the devices, including past experience 
and relevant reports or studies on device performance. Where FDA has 
concerns only about certain types of changes to a particular class I 
device, the agency is proposing 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, for some 
devices FDA is proposing to exempt the 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 under the act, 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 ensure product quality. 

[[Page 38905]]

    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 to a device, 
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 
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 a preamendments device or a legally marketed 
device; 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 in Table I, FDA published final regulations 
classifying, among others, the devices listed below. When FDA 
classified these devices, the agency did not exempt 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.''
    As stated above, 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 
II devices listed below were placed in tier 1, the category of devices 
which have a minimal inherent risk and whose review focuses upon 
intended use. As stated in the Federal Register of July 21, 1994 (59 FR 
37378), FDA is now proposing to reclassify 112 class II, tier 1 devices 
into class I and exempt these devices, along with 12 class I, tier 1 
devices, from the requirement of premarket notification, with 
limitations.
    FDA is proposing to exempt from the requirement of premarket 
notification, with limitations, the 124 generic type of devices 
(including 12 already classified generic types of class I devices; 
chromatographic separation material for clinical use (Sec. 862.2230 (21 
CFR 862.2230)); dental floss (Sec. 872.6390 (21 CFR 872.6390)); 
acoustic chamber for audiometric testing (Sec. 874.1060 (21 CFR 
874.1060)); ear, nose, and throat bur (Sec. 874.4140 (21 CFR 
874.4140)); nasopharyngeal catheter (Sec. 874.4175 (21 CFR 874.4175)); 
otoscope (Sec. 874.4770 (21 CFR 874.4770)); nonpowered breast pump 
(Sec. 884.5150 (21 CFR 884.5150)); unscented menstrual pad 
(Sec. 884.5435 (21 CFR 884.5435)); cast removal instrument 
(Sec. 888.5960 (21 CFR 888.5960)); flotation cushion (Sec. 890.3175 (21 
CFR 890.3175)); traction accessory (Sec. 890.5925 (21 CFR 890.5925)); 
and personnel protective shield (Sec. 892.6500 (21 CFR 892.6500)) 
listed below:

                                 Table 1                                
------------------------------------------------------------------------
                                                               Number of
                                                                devices 
     CFR part                         Title                     proposed
                                                                 to be  
                                                                 exempt 
------------------------------------------------------------------------
862...............  Clinical Chemistry and Clinical                    1
                     Toxicology Devices; May 1, 1987 (52 FR             
                     16102).                                            
866...............  Immunology and Microbiology Devices;               5
                     November 8, 1982 (47 FR 50814).                    
868...............  Anesthesiology Devices; July 16, 1982 (47         40
                     FR 31130).                                         
870...............  Cardiovascular Devices; February 5, 1980          10
                     (45 FR 7904).                                      
872...............  Dental Devices; August 12, 1987 (52 FR             4
                     300820); November 20, 1990 (55 FR                  
                     484360).                                           
874...............  Ear, Nose, and Throat Devices; November            6
                     6, 1986 (51 FR 40378).                             
876...............  Gastroenterology-Urology Devices;                 11
                     November 23, 1983 (48 FR 53012); June              
                     12, 1989 (54 FR 25042).                            
878...............  General and Plastic Surgery Devices; June          4
                     24, 1988 (53 FR 23856).                            
880...............  General Hospital and Personal Use                  4
                     Devices; October 21, 1980 (45 FR 69678).           
882...............  Neurological Devices; September 4, 1979            2
                     (44 FR 51726).                                     
884...............  Obstetrical and Gynecological Devices;            11
                     February 26, 1980 (45 FR 12682).                   
886...............  Ophthalmic Devices; September 2, 1987 (52          4
                     FR 33346); November 20, 1990 (55 FR                
                     48436).                                            
888...............  Orthopedic Devices; September 4, 1987 (52          3
                     FR 33686); November 20, 1990 (55 FR                
                     48436).                                            
890...............  Physical Medicine Devices; November 23,           12
                     1983 (48 FR 53032).                                
892...............  Radiology Devices; January 20, 1988 (53            7
                     FR 1554).                                          
                                                              ----------
      Total.......  .........................................        124
------------------------------------------------------------------------


                                                                        

[[Page 38906]]
      Table 2.--Clinical Chemistry and Clinical Toxicology Devices      
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
862.2230..........  Chromatographic separation material for clinical    
                     use.                                               
------------------------------------------------------------------------



    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of device listed in Table 2 above.

              Table 3.--Immunology and Microbiology Devices             
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
866.2160..........  Coagulase plasma.                                   
866.3720..........  Streptococcus spp. exoenzyme reagents.              
866.5520..........  Immunoglobulin G (Fab fragment specific)            
                     immunological test system.                         
886.5530..........  Immunoglobulin G (Fc fragment specific)             
                     immunological test system.                         
866.5860..........  Total spinal fluid immunological test system.       
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices listed in Table 3 above.

                    Table 4.--Anesthesiology Devices                    
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
868.1100..........  Arterial blood sampling kit.                        
868.1575..........  Gas collection vessel.                              
868.1870..........  Gas volume calibrator.                              
868.2300..........  Bourdon gauge flowmeter.                            
868.2320..........  Uncompensated thorpe tube flowmeter.                
868.2340..........  Compensated thorpe tube flowmeter.                  
868.2350..........  Gas calibration flowmeter.                          
868.2610..........  Gas pressure gauge.                                 
868.2620..........  Gas pressure calibrator.                            
868.2700..........  Pressure regulator.                                 
868.2875..........  Differential pressure transducer.                   
868.2885..........  Gas flow transducer.                                
868.2900..........  Gas pressure transducer.                            
868.5100..........  Nasopharyngeal airway.                              
868.5110..........  Oropharyngeal airway.                               
868.5240..........  Anesthesia breathing circuit.                       
868.5300..........  Carbon dioxide absorbent.                           
868.5310..........  Carbon dioxide absorber.                            
868.5320..........  Reservoir bag.                                      
868.5375..........  Heat and moisture condenser (artificial nose).      
868.5460..........  Therapeutic humidifier for home use.                
868.5530..........  Flexible laryngoscope.                              
868.5540..........  Rigid laryngoscope.                                 
868.5550..........  Anesthetic gas mask.                                
868.5570..........  Nonrebreathing mask.                                
868.5580..........  Oxygen mask.                                        
868.5590..........  Scavenging mask.                                    
868.5600..........  Venturi mask.                                       
868.5770..........  Tracheal tube fixation device.                      
868.5780..........  Tube introduction forceps.                          
868.5790..........  Tracheal tube stylet.                               
868.5810..........  Airway connector.                                   
868.5820..........  Dental protector.                                   
868.5860..........  Pressure tubing and accessories.                    
868.5975..........  Ventilator tubing.                                  
868.5995..........  Tee drain (water trap).                             
868.6400..........  Calibration gas.                                    
868.6820..........  Patient position support.                           
868.6885..........  Medical gas yoke assembly.                          
------------------------------------------------------------------------

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

                    Table 5.--Cardiovascular Devices                    
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
870.2390..........  Phonocardiograph.                                   
870.2600..........  Signal isolation system.                            
870.2620..........  Line isolation monitor.                             
870.2640..........  Portable leakage current alarm.                     
870.2810..........  Paper chart recorder.                               
870.3650..........  Pacemaker polymeric mesh bag.                       
870.3670..........  Pacemaker charger.                                  
870.3690..........  Pacemaker test magnet.                              
870.3935..........  Prosthetic heart valve holder.                      
870.3945..........  Prosthetic heart valve sizer.                       
------------------------------------------------------------------------

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

                        Table 6.--Dental Devices                        
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
872.1840..........  Dental x-ray position indicating device.            
872.1850..........  Lead-lined position indicator.                      
872.4630..........  Dental operating light.                             
872.6390..........  Dental floss.                                       
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices in Table 6 listed above. 
The proposed exemption for dental floss (Sec. 872.6390 (21 CFR 
872.6390)) is limited and would apply only when the device is composed 
of inert material and is not coated or impregnated with chemicals 
intended to provide a therapeutic benefit or interact with tissues of 
the oral cavity.

                 Table 7.--Ear, Nose, and Throat Devices                
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
874.1060..........  Acoustic chamber for audiometric testing.           
874.1080..........  Audiometer calibration set.                         
874.4140..........  Ear, nose, and throat bur.                          
874.4175..........  Nasopharyngeal catheter.                            
874.4350..........  Ear, nose, and throat fiberoptic light source and   
                     carrier.                                           
874.4770..........  Otoscope.                                           
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices listed in Table 7 above. 
The proposed exemption for the otoscope (Sec. 874.4770 (21 CFR 
874.4770)) is limited and would apply only when used in the external 
ear canal.

               Table 8.--Gastroenterology-Urology Devices               
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
876.1075..........  Gastroenterology-urology biopsy instrument.         
876.1400..........  Stomach pH electrode.                               
876.1500..........  Endoscope and accessories.                          
876.1800..........  Urine flow or volume measuring system.              
876.4590..........  Interlocking urethral sound.                        
876.4890..........  Urological catheter and accessories.                
876.5090..........  Suprapublic urological catheter and accessories.    
876.5130..........  Urological catheter and accessories.                
876.5450..........  Rectal dilator.                                     
876.5520..........  Urethral dilator.                                   
876.5540..........  Blood access device and accessories.                
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices listed in Table 8 above. 
The proposed exemption for the gastroenterology- urology biopsy 
instrument (Sec. 876.1075 (21 CFR 876.1075)) is limited and would apply 
only to the biopsy forceps cover and the nonelectric biopsy forceps. 
The proposed exemption for the endoscope and accessories (Sec. 876.1500 
(21 CFR 876.1500)) is limited and would apply only to the following 
specified devices: Photographic accessories for endoscope, 
miscellaneous bulb adapter for endoscope, binocular attachment for 
endoscope, eyepiece attachment for 

[[Page 38907]]
prescription lens, teaching attachment, inflation bulb, measuring 
device for panendoscope, photographic equipment for physiologic 
function monitor, special lens instrument for endoscope, smoke removal 
tube, rechargeable battery box, pocket battery box, bite block for 
endoscope, and cleaning brush for endoscope. The proposed exemption for 
the urine flow or volume measuring system (Sec. 876.1800 (21 CFR 
876.1800)) is limited and would apply only to the disposable, 
nonelectrical urine flow rate measuring device and the nonelectrical 
urinometer. The proposed exemption for the electrically powered 
urological table and accessories (Sec. 876.4890 (21 CFR 876.4890)) is 
limited and would apply only to stirrups. The proposed exemption for 
the suprapubic urological catheter and accessories (Sec. 876.5090 (21 
CFR 876.5090)) is limited and would apply only to the catheter punch 
instrument, nondisposable cannula and trocar, and gastro-urological 
trocar. The proposed exemption for the urological catheters and 
accessories (Sec. 876.5130 (21 CFR 876.5130)) is limited and would 
apply only to the ureteral stylet (guidewire), stylet for gastro-
urological catheter, ureteral catheter holder, ureteral catheter 
adapter, and ureteral catheter connector. The proposed exemption for 
the urethral dilator (Sec. 876.5520 (21 CFR 876.5520)) is limited and 
would apply only to the urethrometer, urological bougie, filiform and 
filiform follower, and metal or plastic urethral sound. Finally, the 
proposed exemption for the blood access device and accessories 
(Sec. 876.5540 (21 CFR 876.5540)) is limited and would apply only to 
the following accessories for both the implanted and the nonimplanted 
blood access device: Cannula clamp, disconnect forceps, crimp plier, 
tub plier, crimp ring, and joint ring.

              Table 9.--General and Plastic Surgery Devices             
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
878.4450..........  Nonabsorbable gauze for internal use.               
878.4810..........  Laser surgical instrument for use in general and    
                     plastic surgery and in dermatology.                
878.5350..........  Needle-type epilator.                               
878.5910..........  Pneumatic tourniquet.                               
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for the devices listed in Table 9 above. The 
proposed exemption for the laser surgical instrument for use in general 
and plastic surgery and in dermatology (Sec. 878.4810 (21 CFR 878.4810) 
is limited and would apply only to gas mixtures used as the lasing 
medium for this class of lasers.

          Table 10.--General Hospital and Personal Use Devices          
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
880.2720..........  Patient scale.                                      
880.2900..........  Clinical color change thermometer.                  
880.6320..........  AC-powered medical examination light.               
880.5560..........  Temperature regulated water mattress.               
------------------------------------------------------------------------

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

                     Table 11.--Neurological Devices                    
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
882.1410..........  Electroencephalograph electrode/lead tester.        
882.4325..........  Cranial drill handpiece (brace).                    
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices listed in Table 11 
above.

            Table 12.--Obstetrical and Gynecological Devices            
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
884.1550..........  Amniotic fluid sampler (amniocentesis tray).        
884.1640..........  Culdoscope and accessories.                         
884.1690..........  Hysteroscope and accessories.                       
884.1700..........  Hysteroscopic insufflator.                          
884.1720..........  Gynecologic laparoscope and accessories.            
884.1730..........  Laparoscopic insufflator.                           
884.4530..........  Obstetric-gynecological specialized manual          
                     instrument.                                        
884.5150..........  Nonpowered breast pump.                             
884.5425..........  Scented or scented deodorized menstrual pad.        
884.5435..........  Unscented menstrual pad.                            
884.5900..........  Therapeutic vaginal douche apparatus.               
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices listed in Table 12 
above. The proposed exemption for the culdoscope and accessories 
(Sec. 884.1640 (21 CFR 884.1640)) and the laparoscope and accessories 
(Sec. 884.1720 (21 CFR 884.1720)) are limited and would apply only to 
culdoscope and laparoscope accessories, respectively, that are not part 
of a specialized instrument or device delivery system and which do not 
have adapters, connectors, channels, or do not have portals for 
electrosurgical, laser, or other power sources. Such culdoscope and 
laparoscope accessory instruments are limited to: Lens cleaning brush; 
biopsy brush; clip applier (without clips); applicator; cannula 
(without trocar or valves); ligature carrier/needle holder; clamp/
hemostat/grasper; curette; instrument guide; ligature passing and 
knotting instrument; suture needle (without suture); retractor, 
mechanical (noninflatable); snare; stylet; forceps; dissector, 
mechanical (noninflatable); scissors; and suction/irrigation probe. The 
proposed exemption for the gynecological hysteroscope and accessories 
(Sec. 884.1690 (21 CFR 884.1690)) is limited and would apply only to 
the following manual accessories: Lens cleaning brush; cannula (without 
trocar or valves); clamp/hemostat/grasper; curette; instrument guide; 
forceps; dissector; mechanical (noninflatable); and scissors. The 
proposed exemption for the hysteroscopic or laparoscopic insufflator 
accessories (Secs. 884.1700 and 884.1730 (21 CFR 884.1700 and 
884.1730), respectively) is limited and would apply only to tubing and 
tubing/filter kits used for hysteroscopic or laparoscopic insufflation 
as single use tubing kits used for only one clinical purpose, i.e., 
pneumoperitoneum or intrauterine insufflation, but not both. The 
proposed exemption does not apply to accessories such as hysteroscopic 
introducer sheaths or Verres needles. The proposed exemption for the 
obstetric-gynecological specialized manual instruments (Sec. 884.4530 
(21 CFR 884.4530)) is limited and would apply only to the following 
devices: Amniotome; uterine curette; cervical dilator (fixed-size 
bougies); cerclage needle; intrauterine device remover; uterine sound; 
and gynecological biopsy forceps. The proposed exemption for the 
nonpowered breast pump (Sec. 884.5150) is limited and would apply only 
if the device is using either a bulb or telescoping mechanism which 
does not develop more than 250 mm Hg suction, and the device materials 
that contact breast or breast milk do not produce cytotoxicity, 
irritation, or sensitization effects. The proposed exemption for the 
scented or scented deodorized menstrual pad (Sec. 884.5425 (21 CFR 
884.5425)) and the unscented menstrual pad (Sec. 884.5435) is limited 
and would 

[[Page 38908]]
apply only if the menstrual pad is made from cotton or rayon and the 
body contact material(s) are safety tested for dermal irritation, 
dermal sensitivity, acute toxicity, and mucosal irritation. Finally, 
the proposed exemption for the therapeutic vaginal douche apparatus 
(Sec. 884.5900 (21 CFR 884.5900)) is limited and would apply only to 
devices which operate by gravity feed.

                      Table 13.--Ophthalmic Devices                     
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
886.1405..........  Ophthalmic trial lens set.                          
886.1750..........  Skiascopic rack.                                    
886.1760..........  Ophthalmic refractometer.                           
886.3200..........  Artificial eye.                                     
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices listed in Table 13 
above. The proposed exemption for the artificial eye (Sec. 886.3200 (21 
CFR 886.3200)) is limited and would apply only to devices made of the 
same materials, have the same chemical composition, and use the same 
manufacturing and disinfection processes as currently legally marketed 
devices.

                      Table 14.--Orthopedic Devices                     
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
888.1100..........  Arthroscope.                                        
888.3000..........  Bone cap.                                           
888.5960..........  Cast removal instrument.                            
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices listed in Table 14 
above. The proposed exemption for the arthroscope (Sec. 888.1100 (21 
CFR 888.1100)) is limited and would apply only to the following manual 
arthroscope instruments: Cannulas, curettes, drill guides, forceps, 
gouges, graspers, knives, obturators, osteotomes, probes, punches, 
rasps, retractors, rongeurs, suture passers, suture knot pushers, 
suture punches, switching rods, and trocars.

                  Table 15.--Physical Medicine Devices                  
------------------------------------------------------------------------
    CFR section                            Device                       
------------------------------------------------------------------------
890.1575..........  Force-measuring platform.                           
890.1600..........  Intermittent pressure measurement system.           
890.1615..........  Miniature pressure transducer.                      
890.3175..........  Flotation cushion.                                  
890.3760..........  Powered table.                                      
890.5380..........  Powered exercise equipment.                         
890.5410..........  Powered finger exerciser.                           
890.5660..........  Therapeutic massager.                               
890.5925..........  Traction accessory.                                 
890.5940..........  Chilling unit.                                      
890.5950..........  Powered heating unit.                               
890.5975..........  Therapeutic vibrator.                               
------------------------------------------------------------------------

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

                      Table 16.--Radiology Devices                      
------------------------------------------------------------------------
 CFR section                            Device                          
------------------------------------------------------------------------
892.1700....  Diagnostic x-ray high voltage generator.                  
892.1760....  Diagnostic x-ray housing assembly.                        
892.1770....  Diagnostic x-ray tube mount.                              
892.1830....  Radiologic patient cradle.                                
892.1880....  Wall-mounted radiographic cassette holder.                
892.5780....  Light beam patient position indicator.                    
892.6500....  Personnel protective shield.                              
------------------------------------------------------------------------

    FDA is proposing to grant an exemption from the requirement of 
premarket notification for each of the devices listed in Table 16 
above. The proposed exemption for the personnel protective shield 
(Sec. 892.6500 (21 CFR 892.6500)) is limited and would only apply to 
devices whose labeling specifies the lead equivalence.

V. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. The Device Priority Model: Development and Applications, 
Office of Standards and Regulations, FDA, Rockville, MD, October 
1989.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment or an environmental impact statement is 
required.

VII. Analysis of Impacts

    FDA has examined the impact 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 or 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.

VIII. Request for Comments

    Interested persons may, on or before October 11, 1995, 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, 884, 888, and 
890

    Medical devices.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services. 

[[Page 38909]]


21 CFR Part 892

    Medical devices, Radiation protection, X-rays.
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 862.2230 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.2230  Chromatographic separation material for clinical use.

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

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    3. 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).

    4. Section 866.2160 is amended by revising paragraph (b) to read as 
follows:


Sec. 866.2160  Coagulase plasma.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    5. Section 866.3720 is amended by revising paragraph (b) to read as 
follows:


Sec. 866.3720  Streptococcus spp. exoenzyme reagents.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    6. Section 866.5520 is amended by revising paragraph (b) to read as 
follows:


Sec. 866.5520  Immnunoglobulin G (Fab 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.
    7. Section 866.5530 is amended by revising paragraph (b) to read as 
follows:


Sec. 866.5530  Immunoglobulin G (Fc 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.
    8. Section 866.5860 is amended by revising paragraph (b) to read as 
follows:


Sec. 866.5860  Total spinal fluid 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

    9. 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).
    10. Section 868.1100 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1100  Arterial blood sampling kit.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    11. Section 868.1575 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1575  Gas collection vessel.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    12. Section 868.1870 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1870  Gas volume calibrator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    13. Section 868.1975 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1975  Water vapor analyzer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    14. Section 868.2300 is amended by revising paragraph (b) to read 
as follows:
Sec. 868.2300  Bourdon gauge flowmeter.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    15. Section 868.2320 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2320  Uncompensated thorpe tube flowmeter.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    16. Section 868.2340 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2340  Compensated thorpe tube flowmeter.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    17. Section 868.2350 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2350  Gas calibration flowmeter.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    18. Section 868.2610 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2610  Gas pressure gauge.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    19. Section 868.2620 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2620  Gas pressure calibrator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    20. Section 868.2700 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2700  Pressure regulator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    21. Section 868.2875 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2875  Differential pressure transducer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    22. Section 868.2885 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2885  Gas flow transducer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket 

[[Page 38910]]
notification procedures in subpart E of part 807 of this chapter.
    23. Section 868.2900 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2900  Gas pressure transducer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    24. Section 868.5100 is amended by revising paragraph (b) to read 
as follows:
Sec. 868.5100  Nasopharyngeal airway.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    25. Section 868.5110 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5110  Oropharyngeal airway.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    26. Section 868.5240 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5240  Anesthesia breathing circuit.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    27. Section 868.5300 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5300  Carbon dioxide absorbent.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    28. Section 868.5310 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5310  Carbon dioxide absorber.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    29. Section 868.5320 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5320  Reservoir bag.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    30. Section 868.5375 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5375  Heat and moisture condenser (artificial nose).

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    31. Section 868.5460 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5460  Therapeutic humidifier for home use.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    32. Section 868.5530 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5530  Flexible laryngoscope.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    33. Section 868.5540 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5540  Rigid laryngoscope.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    34. Section 868.5550 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5550  Anesthetic gas mask.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    35. Section 868.5570 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5570  Nonrebreathing mask.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    36. Section 868.5580 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5580  Oxygen mask.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    37. Section 868.5590 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5590  Scavenging mask.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    38. Section 868.5600 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5600  Venturi mask.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    39. Section 868.5770 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5770  Tracheal tube fixation device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    40. Section 868.5780 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5780  Tube introduction forceps.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    41. Section 868.5790 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5790  Tracheal tube stylet.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    42. Section 868.5810 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5810  Airway connector.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    43. Section 868.5820 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5820 Dental protector.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    44. Section 868.5860 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5860  Pressure tubing and accessories.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    45. Section 868.5975 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5975  Ventilator tubing.

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

[[Page 38911]]

    46. Section 868.5995 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5995  Tee drain (water trap).

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    47. Section 868.6400 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6400  Calibration gas.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    48. Section 868.6820 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6820  Patient position support.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    49. Section 868.6885 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6885  Medical gas yoke assembly.

* * * * *
    (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

    50. 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).

    51. Section 870.2390 is amended by revising paragraph (b) to read 
as follows:
Sec. 870.2390  Phonocardiograph.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    52. Section 870.2600 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.2600  Signal isolation system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    53. Section 870.2620 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.2620  Line isolation monitor.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    54. Section 870.2640 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.2640  Portable leakage current alarm.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    55. Section 870.2810 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.2810  Paper chart recorder.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    56. Section 870.3650 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3650  Pacemaker polymeric mesh bag.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    57. Section 870.3670 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3670  Pacemaker charger.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    58. Section 870.3690 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3690  Pacemaker test magnet.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    59. Section 870.3935 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3935  Prosthetic heart valve holder.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    60. Section 870.3945 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3945  Prosthetic heart valve sizer.

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

PART 872--DENTAL DEVICES

    61. 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).

    62. Section 872.1840 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1840  Dental x-ray position indicating device.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    63. Section 872.1850 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1850  Lead-lined position indicator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    64. Section 872.4630 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4630  Dental operating light.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    65. Section 872.6390 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6390  Dental floss.

* * * * *
    (b) Classification. Class I. If the device is made of inert 
materials and is not coated or impregnated with chemicals intended to 
provide a therapeutic benefit or interact with tissues of the oral 
cavity, it is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter.

PART 874--EAR, NOSE, AND THROAT DEVICES

    66. 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).

    67. Section 874.1060 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1060  Acoustic chamber for audiometric testing.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    68. Section 874.1080 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1080  Audiometer calibration test.

* * * * * 

[[Page 38912]]

    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    69. Section 874.4140 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4140  Ear, nose, and throat bur.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    70. Section 874.4175 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4175  Nasopharyngeal catheter.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    71. Section 874.4350 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4350  Ear, nose, and throat fiberoptic light source and 
carrier.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    72. Section 874.4770 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4770  Otoscope.

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

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    73. 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).

    74. Section 876.1075 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.1075  Gastroenterology-urology biopsy instrument.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the biopsy forceps cover and the nonelectric biopsy 
forceps. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter.
    75. Section 876.1400 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.1400  Stomach pH electrode.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    76. Section 876.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.1500  Endoscope and accessories.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the photographic accessories for endoscope, 
miscellaneous bulb adapter for endoscope, binocular attachment for 
endoscope, eyepiece attachment for prescription lens, teaching 
attachment, inflation bulb, measuring device for panendoscope, 
photographic equipment for physiologic function monitor, special lens 
instrument for endoscope, smoke removal tube, rechargeable battery box, 
pocket battery box, bite block for endoscope, and cleaning brush for 
endoscope. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter.
    77. Section 876.1800 is amended by revising paragraph (b) to read 
as follows:
Sec. 876.1800  Urine flow or volume measuring system.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the disposable, nonelectrical urine flow rate 
measuring device, and nonelectrical urinometer. The devices subject to 
this paragraph (b)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter.
    78. Section 876.4590 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.4590  Interlocking urethral sound.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    79. Section 876.4890 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.4890  Urological table and accessories.

* * * * *
    (b) Classification. (1) Class II (performance standards) for the 
electrically powered urological table and accessories.
    (2) Class I for the manually powered table and accessories, and for 
stirrups for electrically powered table. The devices subject to this 
paragraph (b)(2) are exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter.
    80. Section 876.5090 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5090  Suprapubic urological catheter and accessories.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the catheter punch instrument, nondisposable 
cannula and trocar, and gastro-urological trocar. The devices subject 
to this paragraph (b)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter.
    81. Section 876.5130 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5130  Urological catheter and accessories.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the ureteral stylet (guidewire), stylet for gastro-
urological catheter, ureteral catheter adapter, ureteral catheter 
connector, and ureteral catheter holder. The devices subject to this 
paragraph (b)(2) are exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter.
    82. Section 876.5450 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5450  Rectal dilator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    83. Section 876.5520 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5520  Urethral dilator.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the urethrometer, urological bougie, filiform and 
filiform follower, and metal or plastic urethral sound. The devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
    84. Section 876.5540 is amended by revising paragraph (b)(3) and by 
adding new paragraph (b)(4) to read as follows:


Sec. 876.5540  Blood access device and accessories.

* * * * *
    (b) * * *
    (3) Class II (performance standards) for accessories for both the 
implanted and the nonimplanted blood access devices not listed in 
paragraph (b)(4) of this section.
    (4) Class I for the cannula clamp, disconnect forceps, crimp plier, 
tube plier, crimp ring, and joint ring, 

[[Page 38913]]
accessories for both the implanted and nonimplanted blood access 
device. The devices subject to this paragraph (b)(4) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter.
* * * * *

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    85. 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, 360l, 371).

    86. Section 878.4450 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4450  Nonabsorbable gauze for internal use.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    87. Section 878.4810 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4810  Laser surgical instrument for use in general and plastic 
surgery and in dermatology.

* * * * *
    (b) Classification. (1) Class II.
    (2) Class I for special laser gas mixtures used as a lasing medium 
for this class of lasers. The devices subject to this paragraph (b)(2) 
are exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter.
    88. Section 878.5350 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.5350  Needle-type epilator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    89. Section 878.5910 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.5910  Pneumatic 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

    90. The authority citation for 21 CFR 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).

    91. Section 880.2720 is amended by revising paragraph (b) to read 
as follows:
Sec. 880.2720  Patient scale.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    92. Section 880.2900 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.2900  Clinical color change thermometer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    93. Section 880.5560 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5560  Temperature regulated water mattress.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    94. Section 880.6320 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6320  AC-powered medical examination light.

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

PART 882--NEUROLOGICAL DEVICES

    95. 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).

    96. Section 882.1410 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1410  Electroencephalograph electrode/lead tester.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    97. Section 882.4325 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4325  Cranial drill handpiece (brace).

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

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    98. The authority citation for 21 CFR part 884 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).

    99. Section 884.1550 is revised to read as follows:


Sec. 884.1550  Amniotic fluid sampler (amniocentesis tray.

    (a) Identification. The amniotic fluid sampler (amniocentesis tray) 
is a collection of devices used to aspirate amniotic fluid from the 
amniotic sac via a transabdominal approach. Components of the 
amniocenteses tray include a disposable 3 inch 20 gauge needle with 
stylet and a 30 cc. syringe, as well as the various sample collection 
accessories, such as vials, specimen containers, medium, drapes, etc. 
The device is used at 16-18 weeks gestation for antepartum diagnosis of 
certain congenital abnormalities or anytime after 24 weeks gestation 
when used to assess fetal maturity.
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    100. Section 884.1640 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.1640  Culdoscope and accessories.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for culdoscope accessories that are not part of a 
specialized instrument or device delivery system; do not have adapters, 
connectors, channels, or do not have portals for electrosurgical, 
laser, or other power sources. Such culdoscope accessory instruments 
include: Lens cleaning brush, biopsy brush, clip applier (without 
clips), applicator, cannula (without trocar or valves), ligature 
carrier/needle holder, clamp/hemostat/grasper, curette, instrument 
guide, ligature passing and knotting instrument, suture needle (without 
suture), retractor, mechanical (noninflatable), snare, stylet, forceps, 
dissector, mechanical (noninflatable) scissors, and suction/irrigation 
probe. The devices subject to this paragraph (b)(2) are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    101. Section 884.1690 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.1690  Hysteroscope and accessories.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for hysteroscope accessories that are not part of a 
specialized instrument or device 

[[Page 38914]]
delivery system, do not have adapters, connectors, channels, or do not 
have portals for electrosurgical, laser, or other power sources. Such 
hysteroscope accessory instruments include: Lens cleaning brush, 
cannula (without trocar or valves), clamp/hemostat/grasper, curette, 
instrument guide, forceps, dissector, mechanical (noninflatable), and 
scissors. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter.
    102. Section 884.1700 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.1700  Hysteroscopic insufflator.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for tubing and tubing/filter fits which only include 
accessory instruments which are not used to effect intrauterine access, 
e.g., hysteroscopic introducer sheaths, etc., and single-use tubing 
kits used for only intrauterine insufflation. The devices subject to 
this paragraph (b)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter.
    103. Section 884.1720 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.1720  Gynecologic laparoscope and accessories.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for gynecologic laparoscope accessories that are not 
part of a specialized instrument or device delivery system, do not have 
adapters, connector channels, or do not have portals for 
electrosurgical, lasers, or other power sources. Such gynecologic 
laparoscope accessory instruments include: The lens cleaning brush, 
biopsy brush, clip applier (without clips), applicator, cannula 
(without trocar or valves), ligature carrier/needle holder, clamp/
hemostat/grasper, curette, instrument guide, ligature passing and 
knotting instrument, suture needle (without suture), retractor, 
mechanical (noninflatable), snare, stylet, forceps, dissector, 
mechanical (noninflatable), scissors, and suction/irrigation probe. The 
devices subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
    104. Section 884.1730 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.1730 Laparoscopic insufflator.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for tubing and tubing/filter kits which include 
accessory instruments which are not used to effect intra-abdominal 
access, Verres needles etc., and single-use tubing kits used for only 
intra-abdominal insufflation (pneumoperitoneum). The devices subject to 
this paragraph (b)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter.
    105. Section 884.4530 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.4530  Obstetric-gynecological specialized manual instrument.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the amniotome, uterine curette, cervical dilator 
(fixed-size bougies), cerclage needle, IUD remover, uterine sound, and 
gynecological biopsy forceps. The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter.
    106. Section 884.5150 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.5150  Nonpowered breast pump.

* * * * *
    (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 using either a bulb or telescoping mechanism 
which does not develop more than 250 mm Hg suction, and the device 
materials that contact breast or breast milk do not produce 
cytotoxicity, irritation, or sensitization effects.
    107. Section 884.5425 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.5425  Scented or scented deodorized menstrual pad.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for menstrual pads made from cotton or rayon and for 
which the body contact material(s) and extracts from the absorbent 
material(s) are safety tested for dermal irritation, dermal 
sensitivity, acute toxicity, and mucosal irritation. The devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
    108. Section 884.5435 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.5435  Unscented menstrual pad.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter only when the device is made from cotton or rayon 
and for which the body contact material(s) and extracts from the 
absorbent material(s) are safety tested for dermal irritation, dermal 
sensitivity, acute toxicity, and mucosal irritation.
    109. Section 884.5900 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.5900  Therapeutic vaginal douche apparatus.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I if the device is operated by gravity feed. Devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
PART 886--OPHTHALMIC DEVICES

    110. The authority citation for 21 CFR 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).

    111. Section 886.1405 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1405  Ophthalmic trial lens set.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    112. Section 886.1750 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1750  Skiascopic rack.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    113. Section 886.1760 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1760  Ophthalmic refractometer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    114. Section 886.3200 is revised to read as follows:


Sec. 886.3200  Artificial eye.

    (a) Identification. An artificial eye is a device resembling the 
anterior portion of the eye, usually made of glass or plastic, intended 
to be inserted in a patient's eye socket anterior to an orbital 
implant, or the eviscerated eyeball, for cosmetic purposes. The device 
is not intended to be implanted.
    (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 made from the same materials, has the same 
chemical composition, and uses 

[[Page 38915]]
the same manufacturing processes as currently legally marketed devices.

PART 888--ORTHOPEDIC DEVICES

    115. 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).

    116. Section 888.1100 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.1100  Arthroscope.

* * * * *
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the following manual arthroscopic instruments: 
Cannulas, currettes, drill guides, forceps, gouges, graspers, knives, 
obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, 
suture passers, suture knotpushers, suture punches, switching rods, and 
trocars. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter.
    117. Section 888.3000 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.3000  Bone cap.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    118. Section 888.5960 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.5960  Cast removal instrument.

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

PART 890--PHYSICAL MEDICINE DEVICES

    119. 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).

    120. Section 890.1575 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1575  Force-measuring platform.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    121. Section 890.1600 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1600  Intermittent pressure measurement system.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    122. Section 890.1615 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1615  Miniature pressure transducer.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    123. Section 890.3175 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3175  Flotation cushion.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    124. Section 890.3760 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3760  Powered table.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    125. Section 890.5380 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5380  Powered exercise equipment.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    126. Section 890.5410 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5410  Powered finger exerciser.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    127. Section 890.5660 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5660  Therapeutic massager.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    128. Section 890.5925 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5925  Traction accessory.

* * * * *
    (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, with the exception of Sec. 820.180, 
with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.
    129. Section 890.5940 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5940  Chilling unit.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    130. Section 890.5950 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5950  Powered heating unit.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    131. Section 890.5975 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5975  Therapeutic vibrator.

* * * * *
    (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

    132. 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).

    133. Section 892.1700 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1700  Diagnostic x-ray high voltage generator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    134. Section 892.1760 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1760  Diagnostic x-ray tube housing assembly.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    135. Section 892.1770 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1770  Diagnostic x-ray tube mount.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket 

[[Page 38916]]
notification procedures in subpart E of part 807 of this chapter.
    136. Section 892.1830 is amended by revising paragraph (b) to read 
as follows:
Sec. 892.1830  Radiologic patient cradle.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    137. Section 892.1880 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1880  Wall mounted radiographic cassette holder.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    138. Section 892.5780 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.5780  Light beam patient position indicator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
    139. Section 892.6500 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.6500  Personnel protective shield.

* * * * *
    (b) Classification. Class I. If the device's labeling specifies the 
lead equivalence, it is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter.

    Dated: July 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-18456 Filed 7-27-95; 8:45 am]
BILLING CODE 4160-01-P