[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Pages 3142-3145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1485]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0015]


Medical Devices; Exemptions From Premarket Notification; Class II 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
class II (special controls) devices, subject to certain limitations, 
that are now exempt from the premarket notification requirements under 
the Food and Drug Administration Modernization Act of 1997 (the FDAMA). 
FDA believes that these exemptions will relieve manufacturers from the 
need to submit premarket notification submissions for these devices and 
will enable FDA to redirect the resources that would be spent on 
reviewing such submissions to more significant public health issues. 
FDA is taking this action in order to meet a requirement of the FDAMA.

DATES: Effective January 21, 1998. Comments on this notice should be 
submitted within 90 days of publication. The agency will review any 
comments submitted within the 90-day comment period and will consider 
whether the list of class II devices that are exempt from the premarket 
notification requirements should be modified.

ADDRESSES: Submit written comments on this notice 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 Federal Food, Drug, and Cosmetic Act (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 the Safe Medical Devices Act of 1990 (the SMDA 
(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 assure 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 
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), 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. 
Section

[[Page 3143]]

206 of the FDAMA, in part, added a new section 510(m) to the act. 
Section 510(m)(1) of the act requires FDA, within 60 days after 
enactment of the FDAMA, to publish in the Federal Register a list of 
each type of class II device that does not require a report under 
section 510(k) of the act (generally referred to as a premarket 
notification or ``510(k)'') to provide reasonable assurance of safety 
and effectiveness. Section 510(m) of the act further provides that a 
510(k) will no longer be required for these devices upon the date of 
publication of the list in the Federal Register.
    Section 510(m)(2) of the act provides that, 1 day after date of 
publication of the list under section 510(m)(1), FDA may exempt a 
device on its own initiative or upon petition of an interested person, 
if FDA determines that a 510(k) is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device. This section 
requires FDA to publish in the Federal Register a notice of intent to 
exempt a device, or of the petition, and to provide a 30-day comment 
period. Within 120 days of publication of this document, FDA must 
publish in the Federal Register its final determination. If FDA fails 
to respond to a petition under this section within 180 days of 
receiving it, the petition shall be deemed granted.

II. Criteria for Exemption

    In considering whether to exempt class II devices from premarket 
notification, FDA focused on whether premarket notification for the 
type of device is necessary to provide reasonable assurance of safety 
and effectiveness of the device. FDA considered the following factors: 
(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 has considered the risks associated with false or 
misleading claims, and the frequency, persistence, cause or seriousness 
of the inherent risks of the device); (2) characteristics of the device 
necessary for its safe and effective performance are well established; 
(3) changes in the device that could affect safety and effectiveness 
will either: (a) 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 (b) not materially increase the risk of injury, incorrect 
diagnosis, or ineffective treatment; and (4) any changes to the device 
would not be likely to result in a change in the device's 
classification.
    FDA also considered that even when exempting devices, these devices 
would still be subject to the limitations on exemptions, as described 
in section III of this document.

III. Limitations on Exemptions

    The exemption from the requirement of premarket notification for a 
generic type of device listed in this document applies only to those 
devices that 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. Accordingly, a class II device listed in this document is 
not exempt if such 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 an 
in-vitro device: That is intended for use in the diagnosis, monitoring 
or screening of neoplastic diseases with the exception of 
immunohistochemical devices; is intended for use in screening or 
diagnosis of familial and acquired genetic disorders, including inborn 
errors of metabolism; is intended for measuring an analyte which 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; is intended to assess the risk of 
cardiovascular diseases; is intended for use in diabetes management; is 
intended to identify or infer the identity of a microorganism directly 
from clinical material; is intended 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; is intended for near-patient testing (point 
of care).
    Class II devices incorporating such changes or modifications are 
not exempt from premarket notification because FDA has determined that 
premarket notification is necessary to assure the safety and 
effectiveness of the device.
    In addition to the general limitation on exemptions that applies to 
all class II devices that are described previously, FDA may limit the 
exemption from premarket notification requirements to certain devices 
within a generic class. For example, FDA, in section IV of this 
document, is listing the exemption of the biofeedback device, but 
limits the exemption to prescription battery powered devices that are 
indicated for relaxation training and muscle reeducation. All other 
biofeedback devices are still subject to premarket notification 
requirements because FDA determined that premarket notification was 
necessary to provide a reasonable assurance of safety and effectiveness 
for these devices.
    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. Indeed, FDA's 
determination that premarket notification was unnecessary to provide a 
reasonable assurance of safety and effectiveness for devices listed in 
this document is based, in part, on the assurance of safety and 
effectiveness that other regulatory controls, such as current good 
manufacturing practice requirements, provide.
    Persons with pending 510(k) submissions for devices that are 
exempted in this document, subject to the limitations on exemptions, 
should withdraw their submissions.

IV. List of Class II Devices Exempted

    FDA is identifying the following devices as class II devices that, 
as of the date of publication of this document, are exempt from the 
requirement to submit a premarket notification under section 510(k) of 
the act, subject to limitations on exemptions in this document:

[[Page 3144]]



                                       Table 1.--Exempted Class II Devices                                      
----------------------------------------------------------------------------------------------------------------
    21 CFR Sections                                          Name of Devices                                    
----------------------------------------------------------------------------------------------------------------
862.1440..............  Lactate dehydrogenase test system                                                       
862.1635..............  Total protein test system                                                               
864.6100..............  Bleeding time device                                                                    
864.6400..............  Hematocrit measuring device                                                             
864.9160..............  Blood group substances of nonhuman origin for in vitro diagnostic use                   
864.9550..............  Lectins and protectins                                                                  
864.9575..............  Environmental chamber for storage of platelet concentrate                               
864.9600..............  Potentiating media for in vitro diagnostic use                                          
864.9700..............  Blood storage refrigerator and blood storage freezer                                    
866.3060..............  Blastomyces dermatitidis serological reagents                                           
866.3085..............  Brucella spp. serological reagents                                                      
866.3135..............  Coccidioides immitis serological reagents                                               
866.3165..............  Cryptococcus neoformans serological reagents                                            
866.3220..............  Entamoeba histolytica serological reagents                                              
866.3280..............  Francisella tularensis serological reagents                                             
866.3300..............  Haemophilus spp. serological reagents                                                   
866.3320..............  Histoplasma capsulatum serological reagents                                             
866.3350..............  Leptospira spp. serological reagents                                                    
866.3415..............  Pseudomonas spp. serological reagents                                                   
866.3460..............  Rabiesvirus immunofluorescent reagents                                                  
866.3550..............  Salmonella spp. serological reagents                                                    
866.3660..............  Shigella spp. serological reagents                                                      
866.3930..............  Vibrio cholerae serological reagents                                                    
866.5040..............  Albumin immunological test system                                                       
866.5210..............  Ceruloplasmin immunological test system                                                 
866.5320..............  Properdin factor B immunological test system                                            
866.5380..............  Free secretory component immunological test system                                      
866.5460..............  Haptoglobin immunological test system                                                   
866.5470..............  Hemoglobin immunological test system                                                    
866.5490..............  Hemopexin immunological test system                                                     
876.1620..............  Urodynamics measurement system                                                          
876.1800..............  Urinev flow or volume measuring system                                                  
876.2040..............  Enuresis alarm                                                                          
876.4370..............  Gastroenterlogy-urology evacuator                                                       
876.4650..............  Water jet renal stone dislodger system                                                  
876.4680..............  Uretal stone dislodger                                                                  
876.4890(b)(1)........  Urological table and accessories                                                        
876.5250(b)(1)........  Urine collector and accessories                                                         
880.2200..............  Liquid crystal forehead temperature strip                                               
880.2920..............  Clinical mercury thermometer                                                            
880.5100..............  AC-powered adjustable hospital bed                                                      
880.5140..............  Pediatric hospital bed                                                                  
880.5475..............  Jet lavage                                                                              
880.5500..............  AC-powered patient lift                                                                 
880.5550..............  Alternating pressure air flotation mattress                                             
880.6740..............  Vacuum-powered body fluid suction apparatus                                             
880.6775..............  Powered patient transfer device                                                         
880.6910..............  Wheeled stretcher                                                                       
882.5050..............  Biofeedback device<SUP>1                                                                     
886.3100..............  Ophthalmic tantalum clip                                                                
886.3130..............  Ophthalmic conformer                                                                    
886.3800..............  Scleral shell                                                                           
890.1925..............  Isokinetic testing and evaluation system                                                
890.3500..............  External assembled lower limb prosthesis                                                
890.3710..............  Powered communication system                                                            
890.3725..............  Powered environmental control system                                                    
890.5160..............  Air-fluidized bed                                                                       
890.5170..............  Powered flotation therapy bed                                                           
890.5225..............  Powered patient rotation bed                                                            
890.5720..............  Water circulating hot or cold pack                                                      
890.5740..............  Powered heating pad                                                                     
892.1980..............  Radiologic table                                                                        
----------------------------------------------------------------------------------------------------------------
\1\ Exemption is limited to prescription battery powered devices that are indicated for relaxation training and 
  muscle reeducation and prescription use.                                                                      

V. Additional Exemptions

    Under section 510(m)(2) of the act, as described previously, 
interested persons may request that FDA exempt any class II device from 
the premarket notification requirements. The request should identify 
the generic type of device by the CFR section number (e.g., 21 CFR 
884.1234) and state clearly why the submitter believes the factors 
described in section II of this document apply, and that premarket 
notification requirements

[[Page 3145]]

are not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. By February 19, 1998, FDA will provide 
guidance on how to request such an exemption.

    Dated: January 15, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-1485 Filed 1-16-98; 12:00 pm]
BILLING CODE 4160-01-F