[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Notices]
[Pages 5387-5393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-2498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0009]


Medical Devices; Exemptions From Premarket Notification and 
Reserved Devices; Class I

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
class I devices, subject to certain limitations, that will be exempt 
from premarket notification requirements on February 19, 1998. FDA is 
also publishing a list of those class I devices that FDA believes will 
remain subject to premarket notification requirements because they meet 
the new statutory criteria for premarket notification requirements. 
These lists do not include class I devices that have been previously 
exempted by regulation from the premarket notification requirements. 
FDA is taking this action in order to meet a requirement of the Food 
and Drug Administration Modernization Act of 1997 (the FDAMA). The 
agency requests comments on whether the list of class I devices that 
will remain subject to the premarket notification requirements should 
be modified.

DATES: This notice is effective February 19, 1998. Submit written 
comments by May 4, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Under section 513 of the act (21 U.S.C. 360c), FDA must classify 
devices into one of three regulatory classes: Class I, class II, or 
class III. FDA classification of a device is determined by the amount 
of regulation necessary to provide a reasonable assurance of safety and 
effectiveness. Under the Medical Device Amendments of 1976 (the 1976 
amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices 
Act of 1990 (Pub. L. 101-629), devices are to be classified into class 
I (general controls) if there is information showing that the general 
controls of the act are sufficient to ensure safety and effectiveness; 
into class II (special controls), if general controls, by themselves, 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide such assurance; and into class III (premarket 
approval), if there is insufficient information to support classifying 
a device into class I or class II and the device is a life-sustaining 
or life-supporting device, or is for a use which is of substantial 
importance in preventing impairment of human health, or presents a 
potential unreasonable risk of illness or injury. Most generic types of 
devices that were on the market before the date of the 1976 amendments 
(May 28, 1976) (generally referred to as preamendments devices) have 
been classified by FDA under the procedures set forth in section 513(c) 
and (d) of the act through the issuance of classification regulations 
into one of these three regulatory classes. Devices introduced into 
interstate commerce for the first time on or after May 28, 1976 
(generally referred to as postamendments devices) are classified 
through the premarket notification process under section

[[Page 5388]]

510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the 
implementing regulations, 21 CFR part 807, require persons who intend 
to market a new device to submit a premarket notification report 
containing information that allows FDA to determine whether the new 
device is substantially equivalent within the meaning of section 513(i) 
of the act to a legally marketed device that does not require premarket 
approval. Unless exempted from premarket notification requirements, 
persons may not market a new device under section 510(k) of the act, 
unless they receive a substantial equivalence order from FDA or an 
order reclassifying the device into class I or class II, section 513(i) 
of the act. On November 21, 1997, the President signed into law the 
FDAMA (Pub. L. 105-115). Section 206 of the FDAMA, in part, added a new 
section 510(l) to the act. Under section 501 of the FDAMA, new section 
510(l) of the act becomes effective on February 19, 1998. New section 
510(l) of the act provides that a class I device is exempt from the 
premarket notification requirements under section 510(k) of the act, 
unless the device is intended for a use which is of substantial 
importance in preventing impairment of human health or it presents a 
potential unreasonable risk of illness or injury (hereafter ``reserved 
criteria''). Based on these reserved criteria, FDA has evaluated all 
class I devices to determine which device types should be subject to 
premarket notification requirements.
    In developing the list of reserved devices, the agency considered 
its experience in reviewing premarket notifications for these device 
types, focusing on the risk inherent with the device and/or the disease 
being treated or diagnosed, e.g., devices with rapidly evolving 
technology or expansions of intended uses. The agency considered the 
history of adverse event reports under the medical device reporting 
program for these devices, as well as their history of product recalls. 
Given the inherent risks with the devices listed and/or the disease or 
condition being treated or diagnosed, FDA believes that the devices 
listed as reserved are intended for a use that is of substantial 
importance in preventing impairment of human health or present a 
potential unreasonable risk of illness or injury. In this notice, FDA 
is publishing two lists of devices: (1) A list of the class I devices 
that FDA believes will be exempt from the premarket notification 
requirements on February 19, 1998, under section 510(l) of the act, 
subject to certain limitations from the premarket notification 
requirements described herein; and (2) a list of the devices that FDA 
believes fit the reserved criteria under section 510(l) of the act and, 
therefore, will continue to be subject to premarket notification 
requirements. These lists do not include class I devices that have been 
previously exempted by regulation from the premarket notification 
requirements. FDA believes that class I devices that have previously 
been exempted generally do not fall within the reserved criteria under 
section 510(l) of the act. When FDA issues a proposed rule to amend the 
regulations to codify class I devices that remain subject to the 
premarket notification requirements, FDA, in limited cases, may propose 
to revoke the exemption from the premarket notification requirements 
based on the reserved criteria of section 510(l) of the act.

II. Limitations on Exemptions

    As stated previously, FDA believes that the generic types of class 
I devices listed herein, in addition to a vast majority of class I 
devices previously exempted, should be exempt from the premarket 
notification requirements under section 510(l) of the act. FDA further 
believes, however, that these generic device categories should be 
exempt only to the extent that they have existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, for 
which a misdiagnosis as a result of using the device, would not be 
associated with high morbidity or mortality. FDA believes that certain 
changes to devices within a generic type that is generally exempt may 
make the device intended for a use that is of substantial importance in 
preventing impairment of human health or may make the device present a 
potential unreasonable risk of illness or injury. Accordingly, devices 
changed in this manner would fall within the reserved criteria under 
section 510(l) of the act and would require premarket notification.
    FDA believes that devices that have different intended uses than 
legally marketed devices in that generic type present a potential 
unreasonable risk of illness or injury because their safety and 
effectiveness characteristics are unknown. Moreover, FDA believes that 
in vitro diagnostic devices that are intended for a use, for which a 
misdiagnosis as a result of using the device, could result in high 
morbidity or mortality, either are intended for a use that is of 
substantial importance in preventing impairment of human health or 
present a potential unreasonable risk of illness or injury.
    Accordingly, because FDA believes that devices incorporating the 
characteristics described above fit within the reserved criteria under 
section 510(l) of the act, FDA considers any class I device to be 
subject to premarket notification requirements if the device: (1) Has 
an intended use that is different from the intended use of a legally 
marketed device in that generic type; 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) operates using a 
different fundamental scientific technology than that used by a legally 
marketed device in that generic type, 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 or amplification technology rather than culture or 
immunoassay technology; or (3) is a in-vitro device that is intended: 
(a) For use in the diagnosis, monitoring or screening of neoplastic 
diseases with the exception of immunohistochemical devices; (b) for use 
in screening or diagnosis of familial and acquired genetic disorders, 
including inborn errors of metabolism; (c) for measuring an analyte 
that serves as a surrogate marker for screening, diagnosis, or 
monitoring life threatening diseases such as acquired immune deficiency 
syndrome (AIDS), chronic or active hepatitis, tuberculosis, or 
myocardial infarction or to monitor therapy; (d) to assess the risk of 
cardiovascular diseases; (e) for use in diabetes management; (f) to 
identify or infer the identity of a microorganism directly from 
clinical material; (g) for detection of antibodies to microorganisms 
other than immunoglobulin G (IgG) and IgG assays when the results are 
not qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma; uses 
noninvasive testing; and (h) for near patient testing (point of care).
    Class I devices incorporating such changes or modifications are not 
exempt from premarket notification because FDA believes they meet the 
reserved criteria described above, under 510(l).
    In addition to the general limitation on exemptions that FDA 
considers applicable to all class I devices that is described above, 
FDA also considers certain devices within a generic class to remain 
subject to the premarket notification requirements because they

[[Page 5389]]

either are intended for a use that is of substantial importance in 
preventing impairment of human health or they present a potential 
unreasonable risk of illness or injury. For example, FDA, elsewhere in 
this document, states that it considers liquid bandages generally to be 
exempt from the premarket notification requirements, but considers a 
subcategory of those devices, those intended for treatment of burns and 
other open wounds, to remain subject to the premarket notification 
requirements. FDA believes that liquid bandages intended for burns and 
other open wounds should remain subject to this requirement because 
they are of substantial importance in preventing impairment of human 
health by helping to prevent infections.
    FDA advises additionally that an exemption from the requirement of 
premarket notification does not mean that the device is exempt from any 
other statutory or regulatory requirements, unless such exemption is 
explicitly provided by order or regulation.

III. Lists of Devices

    The following devices are devices that FDA believes meet the 
reserved criteria in section 206 of the FDAMA and, therefore, would 
remain subject to premarket notification under new section 510(l) added 
to the act:

                                       Table 1.--Reserved Class I Devices                                       
----------------------------------------------------------------------------------------------------------------
    21 CFR Section                                           Name of Device                                     
----------------------------------------------------------------------------------------------------------------
862.1065..............  Ammonia test system                                                                     
862.1113..............  Bilirubin (total and unbound) in the neonate test system                                
862.1410..............  Iron (non-heme) test system                                                             
862.1415..............  Iron-binding capacity test system                                                       
862.1495..............  Magnesium test system                                                                   
862.1580..............  Phosphorous (inorganic) test system                                                     
862.1660..............  Quality control material (assayed and unassayed)\1\                                     
862.1680..............  Testosterone test system                                                                
862.1775..............  Uric acid test system                                                                   
862.3110..............  Antimony test system                                                                    
862.3120..............  Arsenic test system                                                                     
862.3220..............  Carbon monoxide test system                                                             
862.3240..............  Cholinesterase test system                                                              
862.3600..............  Mercury test system                                                                     
864.7040..............  Adenosine triphosphate release assay                                                    
864.8950..............  Russell viper venom reagent                                                             
864.9050..............  Blood bank supplies                                                                     
864.9125..............  Vacuum-assisted blood collection system                                                 
864.9195..............  Blood mixing devices and blood weighing devices\2\                                      
866.2390..............  Transport culture medium                                                                
866.2560..............  Microbial growth monitor\3\                                                             
866.2850..............  Automated zone reader                                                                   
866.2900..............  Microbiological specimen collection and transport device                                
866.3110..............  Campylobacter fetus serological reagents                                                
866.3120..............  Chlamydia serological reagents                                                          
866.3235..............  Epstein-Barr virus serological reagents                                                 
866.3370..............  Mycobacterium tuberculosis immunofluorescent reagents                                   
866.3870..............  Trypanosoma spp. serological reagents                                                   
872.4200..............  Dental handpiece and accessories                                                        
872.6250..............  Dental chair and accessories\4\                                                         
872.6640..............  Dental operative unit and accessories\5\                                                
872.6710..............  Boiling water sterilizer                                                                
876.5160..............  Urological clamps for males\6\                                                          
878.4460..............  Surgeon's glove                                                                         
880.5090..............  Liquid bandage\7\                                                                       
880.5680..............  Pediatric position holder                                                               
880.6250..............  Patient examination glove                                                               
880.6375..............  Patient lubricant                                                                       
880.6760..............  Protective restraint                                                                    
882.1030..............  Ataxiagraph                                                                             
882.1420..............  Electroencephalogram (EEG) signal spectrum analyzer                                     
882.4060..............  Ventricular cannula\8\                                                                  
882.4545..............  Shunt system implantation instrument\9\                                                 
884.2980(a)...........  Telethermographic system\10\                                                            
884.2982(a)...........  Liquid crystal thermographic system\11\                                                 
886.4070..............  Powered corneal burr\12\                                                                
886.4300..............  Intraocular lens guide\13\                                                              
886.4370..............  Keratome                                                                                
888.1500..............  Goniometer                                                                              
890.3850..............  Mechanical wheelchair                                                                   
890.5710..............  Hot or cold disposable packs\14\                                                        
892.1100..............  Scintillation (gamma) camera                                                            
892.1110..............  Positron camera                                                                         
----------------------------------------------------------------------------------------------------------------
\1\ Meets reserved criteria when assayed and unassayed when used for donor screening.                           
\2\ Meets reserved criteria when automated.                                                                     
\3\ Meets reserved criteria when automated blood culturing systems.                                             
\4\ Meets reserved criteria when dental chair with the operative unit.                                          
\5\ Meets reserved criteria when it is not the accessory tray to the unit.                                      

[[Page 5390]]

                                                                                                                
\6\ Meets reserved criteria when devices are for internal use or are used for females.                          
\7\ Meets reserved criteria for uses other than as a skin protectant.                                           
\8\ Meets reserved criteria if not made of surgical grade stainless steel.                                      
\9\ Meets reserved criteria if not made of surgical stainless steel.                                            
\10\ Meets reserved criteria if an adjunct use system.                                                          
\11\ Meets reserved criteria if nonelectrically powered and AC-powered adjunctive system.                       
\12\ Meets reserved criteria if for use other than for removing rust rings.                                     
\13\ Meets reserved criteria if used as folders and injectors for soft or foldable IOL's.                       
\14\ Meets reserved criteria if indicated for use on infants.                                                   

    The following devices are devices that FDA believes do not meet the 
reserved criteria under section 206 of the FDAMA and, therefore, will 
be exempt from premarket notification as of February 19, 1998, under 
new section 510(l) added to the act:

                                       Table 2.--Exempted Class I Devices                                       
----------------------------------------------------------------------------------------------------------------
    21 CFR Section                                           Name of Device                                     
----------------------------------------------------------------------------------------------------------------
862.1030..............  Alanine amino transferase (ALT/SGPT) test system                                        
862.1040..............  Aldolase test system                                                                    
862.1060..............  Delta-aminolevulinic acid test system                                                   
862.1075..............  Androstenedione test system                                                             
862.1080..............  Androsterone test system                                                                
862.1095..............  Ascorbic acid test system                                                               
862.1115..............  Urinary bilirubin and its conjugates (nonquantitative) test system                      
862.1130..............  Blood volume test system                                                                
862.1135..............  C-peptides of proinsulin test system                                                    
862.1165..............  Catecholamines (total) test system                                                      
862.1175..............  Cholesterol (total) test system                                                         
862.1180..............  Chymotrypsin test system                                                                
862.1185..............  Compound S (11-deoxycortisol) test system                                               
862.1195..............  Corticoids test system                                                                  
862.1200..............  Corticosterone test system                                                              
862.1240..............  Cystine test system                                                                     
862.1245..............  Dehydroepiandrosterone (free and sulfate) test system                                   
862.1250..............  Desoxycorticosterone test system                                                        
862.1260..............  Estradiol test system                                                                   
862.1265..............  Estriol test system                                                                     
862.1270..............  Estrogen (total, in pregnancy) test system                                              
862.1275..............  Estrogens (total, nonpregnancy) test system                                             
862.1280..............  Estrone test system                                                                     
862.1285..............  Etiocholanolone test system                                                             
862.1300..............  Follicle-stimulating hormone test system                                                
862.1310..............  Galactose test system                                                                   
862.1325..............  Gastrin test system                                                                     
862.1330..............  Globulin test system                                                                    
862.1335..............  Glucagon test system                                                                    
862.1360..............  Gamma-glutamyl transpeptidase and isoenzymes test system                                
862.1370..............  Human growth hormone test system                                                        
862.1375..............  Histidine test system                                                                   
862.1385..............  17-Hydroxycorticosteroids (17-ketogenic steroids) test system                           
862.1390..............  5-Hydroxyindole acetic acid/serotonin test system                                       
862.1395..............  17-Hydroxyprogesterone test system                                                      
862.1400..............  Hydroxyproline test system                                                              
862.1405..............  Immunoreactive insulin test system                                                      
862.1430..............  17-Ketosteroids test system                                                             
862.1435..............  Ketones (nonquantitative) test system                                                   
862.1450..............  Lactic acid test system                                                                 
862.1460..............  Leucine aminopeptidase test system                                                      
862.1465..............  Lipase test system                                                                      
862.1475..............  Lipoprotein test system                                                                 
862.1485..............  Luteinizing hormone test system                                                         
862.1500..............  Malic dehydrogenase test system                                                         
862.1505..............  Mucopolysaccharides (nonquantitative) test sytem                                        
862.1510..............  Nitrite (nonquantitative) test system                                                   
862.1520..............  5'-Nucleotidase test system                                                             
862.1530..............  Plasma oncometry test system                                                            
862.1535..............  Ornithine carbamyl transferase test system                                              
862.1540..............  Osmolality test system                                                                  
862.1542..............  Oxalate test system                                                                     
862.1550..............  Urinary pH (nonquantitative) test system                                                
862.1560..............  Urinary phenylketones (nonquantitative) test system                                     
862.1570..............  Phosphohexose isomerase test system                                                     
862.1590..............  Porphobilinogen test system                                                             
862.1595..............  Porphyrins test system                                                                  
862.1605..............  Pregnanediol test system                                                                

[[Page 5391]]

                                                                                                                
862.1610..............  Prenanetriol test system                                                                
862.1615..............  Pregnenolone test system                                                                
862.1620..............  Progesterone test system                                                                
862.1625..............  Prolactin (lactogen) test system                                                        
862.1630..............  Protein (fractionation) test system                                                     
862.1645..............  Urinary protein or albumin (nonquantitative) test system                                
862.1650..............  Pyruvate kinase test system                                                             
862.1655..............  Pyruvic acid test system                                                                
862.1660..............  Quality control material (assayed and unassayed)\1\                                     
862.1705..............  Triglyceride test system                                                                
862.1725..............  Trypsin test system                                                                     
862.1730..............  Free tyrosine test system                                                               
862.1780..............  Urinary calculi (stones) test system                                                    
862.1785..............  Urinary urobilinogen (nonquantitative) test system                                      
862.1790..............  Uroporphyrin test system                                                                
862.1795..............  Vanilmandelic acid test system                                                          
862.1805..............  Vitamin A test system                                                                   
862.1820..............  Xylose test system                                                                      
862.2140..............  Centrifugal chemistry analyzer for clinical use                                         
862.2150..............  Continuous flow sequential multiple chemistry analyzer for clinical use                 
862.2160..............  Discrete photometric chemistry analyzer for clinical use                                
862.2170..............  Micro chemistry analyzer for clinical use                                               
862.2250..............  Gas liquid chromatography system for clinical use                                       
862.2260..............  High pressure liquid chromatography system for clinical use                             
862.2270..............  Thin-layer chromatography system for clinical use                                       
862.2300..............  Colorimeter photometer, or spectrophotometer for clinical use                           
862.2400..............  Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical 
                         use                                                                                    
862.2500..............  Enzyme analyzer for clinical use                                                        
862.2540..............  Flame emission photometer for clinical use                                              
862.2560..............  Fluorometer for clinical use                                                            
862.2680..............  Microtitrator for clinical use                                                          
862.2700..............  Nephelometer for clinical use                                                           
862.2730..............  Osmometer for clinical use                                                              
862.2750..............  Pipetting and diluting system for clinical use                                          
862.2850..............  Atomic absorption spectrophotometer for clinical use                                    
862.2860..............  Mass spectrometer for clinical use                                                      
862.2900..............  Automated urinalysis system                                                             
862.3280..............  Clinical toxicology control material                                                    
864.2280..............  Cultured animal and human cells                                                         
864.5240..............  Automated blood cell diluting apparatus                                                 
864.9185..............  Blood grouping view box                                                                 
864.9195..............  Blood mixing devices and blood weighing devices\2\                                      
864.9225..............  Cell-freezing apparatus and reagents for in vitro diagnostic use                        
864.9275..............  Blood bank centrifuge for in vitro diagnostic use                                       
864.9320..............  Copper sulphate solution for specific gravity determination                             
864.9750..............  Heat-sealing device                                                                     
866.2660..............  Microorganism differentiation and identification device                                 
866.3040..............  Aspergillus spp. serological reagents                                                   
866.3140..............  Corynebacterium spp. serological reagents                                               
866.3145..............  Coxsackievirus serological reagents                                                     
866.3200..............  Echinococcus spp. serological reagents                                                  
866.3240..............  Equine encephalomyelitis virus serological reagents                                     
866.3355..............  Listeria spp. serological reagents                                                      
866.3360..............  Lymphocytic choriomeningitis virus serological reagents                                 
866.3375..............  Mycoplasma spp. serological reagents                                                    
866.3380..............  Mumps virus serological reagents                                                        
866.3405..............  Poliovirus serological reagents                                                         
866.3480..............  Respiratory syncytial virus serological reagents                                        
866.3500..............  Rickettsia serological reagents                                                         
866.3600..............  Schistosoma spp. serological reagents                                                   
866.3680..............  Sporothrix scheneckii serological reagents                                              
866.3740..............  Streptococcus spp. serological reagents                                                 
866.3850..............  Trichinella spiralis serological reagents                                               
866.5060..............  Prealbumin immunological test system                                                    
866.5065..............  Human allotypic marker immunological test system                                        
866.5160..............  Beta-globulin immunological test system                                                 
866.5200..............  Carbonic anhydrase B and C immunological test system                                    
866.5330..............  Factor XIII, A, S, immunological test system\3\                                         
866.5400..............  Alpha-globulin immunological test system                                                
866.5420..............  Alpha-I-glycoproteins immunological test system                                         
866.5425..............  Alpha-2-glycoproteins immunological test system                                         
866.5430..............  Beta-2-glycoprotein I immunological test system                                         

[[Page 5392]]

                                                                                                                
866.5440..............  Beta-2-glycoprotein III immunological test system                                       
866.5560..............  Lactic dehydrogenase immunological test system                                          
866.5570..............  Lactoferrin immunological test system                                                   
866.5590..............  Lipoprotein X immunological test system                                                 
866.5715..............  Plasminogen immunological test system                                                   
866.5735..............  Prothrombin immunological test system\4\                                                
866.5765..............  Retinol-binding protein immunological test system                                       
866.5890..............  Inter-alpha trypsin inhibitor immunological test system                                 
868.1910..............  Esophageal stethoscope                                                                  
868.5620..............  Breathing mouthpiece                                                                    
868.5640..............  Medicinal nonventilatory nebulizer (atomizer)                                           
868.5675..............  Rebreathing device                                                                      
868.5700..............  Nonpowered oxygen tent                                                                  
868.6810..............  Tracheobronchial suction catheter                                                       
872.3400(b)(1)........  Karaya and sodium borate with or without acacia denture adhesive                        
874.1070..............  Short increment sensitivity index (SISI) adapter                                        
874.1500..............  Gustometer                                                                              
874.1800..............  Air or water caloric stimulator                                                         
874.1925..............  Toynbee diagnostic tube                                                                 
874.3300(b)(1)........  Hearing aid\5\                                                                          
874.4100..............  Epistaxis balloon                                                                       
874.5300..............  Ear, nose, and throat examination and treatment unit                                    
874.5550..............  Powered nasal irrigator                                                                 
874.5840..............  Antistammering device                                                                   
876.5160..............  Urological clamps for males\6\                                                          
876.5210..............  Enema kit                                                                               
876.5250(b)(2)........  Urine collector and accessories                                                         
878.4040..............  Surgical apparel\7\                                                                     
878.4200..............  Introduction/drainage catheter and accessories                                          
878.4320..............  Removable skin clip                                                                     
878.4680..............  Nonpowered, single patient, portable suction apparatus                                  
878.4760..............  Removable skin staple                                                                   
878.4820..............  Surgical instrument motors and accessories/attachments                                  
878.4960..............  Operating tables and accessories and operating chair and accessories                    
880.5090..............  Liquid bandage\8\                                                                       
880.5270..............  Neonatal eye pad                                                                        
880.5420..............  Pressure infusor for an I.V. bag                                                        
882.4060..............  Ventricular cannula\9\                                                                  
882.4545..............  Shunt system implantation instrument\10\                                                
882.4650..............  Neurosurgical suture needle                                                             
882.4750..............  Skull punch\11\                                                                         
884.1040..............  Viscometer for cervical mucus                                                           
886.1350..............  Keratoscope\12\                                                                         
886.1780..............  Retinoscope\13\                                                                         
886.1940..............  Tonometer sterilizer                                                                    
886.4070..............  Powered corneal burr\14\                                                                
886.4300..............  Intraocular lens guide\15\                                                              
886.5850..............  Sunglasses (nonprescription)                                                            
890.5180..............  Manual patient rotation bed                                                             
890.5710..............  Hot or cold disposable pack\16\                                                         
892.1300..............  Nuclear rectilinear scanner                                                             
892.1320..............  Nuclear uptake probe                                                                    
892.1330..............  Nuclear whole body scanner                                                              
892.1410..............  Nuclear electrocardiograph synchronizer                                                 
892.1890..............  Radiographic film illuminator                                                           
892.1910..............  Radiographic grid                                                                       
892.1960..............  Radiographic intensifying screen                                                        
892.1970..............  Radiographic ECG/respirator, synchronizer                                               
892.5650..............  Manual radionuclide applicator system                                                   
----------------------------------------------------------------------------------------------------------------
\1\ Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.     
\2\ Exemption is limited to manual devices.                                                                     
\3\ This exemption should not be confused with Sec.  864.7290.                                                  
\4\ This exemption should not be confused with Secs.  864.5425 or 864.7750.                                     
\5\ Exemption is limited to air-conduction hearing aids.                                                        
\6\ Exemption does not include devices for internal use or devices used for females.                            
\7\ Exemption is limited to class I category other than surgical gowns and surgical masks.                      
\8\ Exemption is limited to uses as a skin protectant.                                                          
\9\ Exemption is limited to surgical grade stainless steel.                                                     
\10\ Exemption is limited to devices made of surgical grade stainless steel.                                    
\11\ Exemption should not be confused with Sec.  882.4305.                                                      
\12\ Exemption is extended to those with software.                                                              
\13\ Exemption is limited to class I battery-powered devices.                                                   
\14\ Exemption is limited to rust ring removal.                                                                 

[[Page 5393]]

                                                                                                                
\15\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.                      
\16\ Exemption does not apply when indicated for infants.                                                       

IV. Comments

    Interested persons may, on or before May 4, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
the notice. 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.

    Dated: January 23, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-2498 Filed 1-30-98; 8:45 am]
BILLING CODE 4160-01-F