[Federal Register Volume 63, Number 218 (Thursday, November 12, 1998)]
[Proposed Rules]
[Pages 63222-63253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 
884, 886, 888, 890, and 892

[Docket No. 98N-0009]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its classification regulations to designate class I devices that are 
exempt from the premarket notification requirements, subject to certain 
limitations, and to designate those class I devices that remain subject 
to premarket notification requirements under the new statutory criteria 
for premarket notification requirements. The devices FDA is proposing 
to designate as exempt do not include class I devices that have been 
previously exempted by regulation from the premarket notification 
requirements. This action is being taken under the Federal Food, Drug, 
and Cosmetic Act (the act), as amended by the Medical Device Amendments 
of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 
(SMDA), and the Food and Drug Administration Modernization Act of 1997 
(FDAMA). FDA is taking this action in order to implement a requirement 
of FDAMA.

DATES:  Written comments by January 26, 1999.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Device 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

[[Page 63223]]

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 1976 amendments (Pub. L. 94-295), as amended 
by 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 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 
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the 
implementing regulations, part 807 (21 CFR part 807), require persons 
who intend to market a new device to submit a premarket notification 
report (510(k)) 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, 
under section 513(f) of the act.
    On November 21, 1997, the President signed FDAMA into law (Pub. L. 
105-115). Section 206 of FDAMA, in part, added a new section 510(l) to 
the act. Under section 206 of the FDAMA, new section 510(l) of the act 
became 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. This document refers to these 
devices that FDA believes meet these criteria as ``reserved.'' 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. 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 the Federal Register of February 2, 1998 (63 FR 5387), FDA 
published a list of devices it considered reserved and that require 
premarket notification and a list of devices it believed met the 
exemption criteria in FDAMA. FDA invited comments on the February 2, 
1998, notice. Responses to these comments are addressed in this 
document.
    FDA is now proceeding to designate which devices require premarket 
notification, and which are exempt, subject to limitations, under 
notice and comment rulemaking proceedings under new section 510(l). The 
devices FDA is proposing to designate as requiring premarket 
notification include five devices that are currently exempt from 
premarket notification because FDA believes they meet the reserved 
criteria: Quinine test system Sec. 862.3750 (21 CFR 862.3750), 
Sulfonamide test system Sec. 862.3850 (21 CFR 862.3850), 
Cardiopulmonary bypass accessory equipment Sec. 870.4200 (21 CFR 
870.4200), Ophthalmic eye shield Sec. 886.4750 (21 CFR 886.4750) (when 
made of other than plastic or aluminum), and Electrode cable 
Sec. 890.1175 (21 CFR 890.1175). FDA also is proposing to modify the 
limitations language for all class I devices that are currently exempt.

II. Limitations on Exemptions

    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 (IVD's), 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 device 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 device type present a 
potential unreasonable risk of illness or injury because their safety 
and effectiveness characteristics are unknown. Moreover, FDA believes 
that IVD's 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 previously 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: (a) Has 
an intended use that is different from the intended use of a legally 
marketed device in that generic type of 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 (b) operates 
using a different fundamental scientific technology than that used by a 
legally marketed device in that generic type of device (e.g., a 
surgical instrument cuts tissue with a laser beam rather than with a 
sharpened metal blade, or an IVD 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 (c) is an in vitro device that is intended: 
(1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical

[[Page 63224]]

devices; (2) for use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism; (3) 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; (4) to 
assess the risk of cardiovascular diseases; (5) for use in diabetes 
management; (6) to identify or infer the identity of a microorganism 
directly from clinical material; (7) 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; 
(8) for noninvasive testing as defined in Sec. 812.3(k) (21 CFR 
812.3(k); and (9) for near patient testing (point of care).
    FDA is proposing to revise Secs. 862.9, 864.9, and 866.9 (21 CFR 
862.9, 864.9, and 866.9) to incorporate the revised limitations on 
exemptions for IVD's as set forth previously. FDA believes that these 
limitations, for the reasons described previously, are appropriate for 
IVD's.
    FDA is also proposing to amend all current limitations on 
exemptions sections (21 CFR 862.9, 864.9, 866.9, 868.9, 870.9, 872.9, 
874.9, 876.9, 878.9, 880.9, 882.9, 884.9, 886.9, 888.9, 890.9, and 
892.9) in two ways. First the proposed limitations language clarifies 
that these limitations apply to class II, as well as class I devices. 
On January 21, 1998 (63 FR 3142), FDA published a list of exempted 
class II devices, subject to certain limitations. Under section 
510(m)(1), as added by FDAMA, FDA was provided the authority to exempt 
these class II devices upon issuance of a notice. FDA intends to codify 
these exemptions, including the limitations described in the January 
21, 1998, Federal Register notice, by issuance of a final rule in the 
near future.
    The limitations language that is proposed in this document for 
class I devices is identical to those limitations for class II devices 
that became effective on January 21, 1998. Accordingly, the proposed 
limitations sections state that the scope of these limitations apply to 
class II, as well as class I devices.
    Second, FDA is proposing to amend the limitations language to state 
that premarket notifications must be submitted for class I exempt 
devices if the intended use is different than the ``legally marketed 
devices in that generic type.'' Currently, the limitations in 
Sec. ______.9 of each classification regulation part (e.g., 
Secs. 862.9, 864.9, etc.) states that manufacturers must submit 
premarket notifications for class I exempt devices when ``[t]he 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 to which it had been determined to be 
substantially equivalent;''.
    FDA believes that devices that have an intended use that differs 
from any legally marketed device should not be exempt because those 
devices present a potential unreasonable risk of illness or injury 
because their safety and effectiveness characteristics are unknown. 
Manufacturers of such devices should submit a premarket notification 
and the agency will determine if they are substantially equivalent to 
other legally marketed devices in that generic device type.
    In addition to the general limitations on exemptions that FDA 
considers applicable to all class I devices that are described 
previously, FDA also considers certain devices within a generic class 
to remain subject to the premarket notification requirements because 
they 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, elsewhere in this 
document, FDA 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 also advises 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. Analysis of Comments to the February 2, 1998, Notice

    1. One comment proposed that general purpose instruments (21 CFR 
862.2140, 862.2150, 862.2160, 862.2170, 862.2250, 862.2260, 862.2300, 
862.2400, 862.2500, 862.2540, 862.2560, 862.2680, 862.2700, 862.2730, 
and 862.2750) designed to perform clinical testing that provide results 
that are intended to be of ``substantial importance in preventing 
impairment of human health, or presents a potential risk of illness or 
injury'' should not be exempt.
    If these devices are not subject to the proposed limitations in 
Sec. 862.9, FDA does not believe that premarket notification is 
necessary because these devices do not meet the reserved criteria. 
Laboratory instruments, like other devices, should be regulated 
according to risk and the risk associated with any device is related to 
intended use and indications for use. As general purpose instruments, 
these devices make no specific claims and their safety and 
effectiveness can be reasonably assured by using other general 
controls, including design controls (if the instrument includes 
computer automation). If the labeling includes indications for specific 
analytes on the general purpose instrument, the devices would not meet 
the reserved criteria. Under proposed Sec. 862.9, these devices would 
be subject to the limitations on exemptions and, therefore, would be 
not be exempt from premarket notification. Review of the system and its 
indications by FDA would be required through a new premarket 
notification.
    2. One comment stated that general purpose instruments should not 
be exempt from premarket notification because they could be used in a 
physician's office or near patient testing (point of care) by 
nonlaboratory trained individuals resulting in major threats to patient 
health.
    FDA believes that these concerns are addressed by the limitations 
on exemptions. Under Sec. 862.9(c), devices that are ``for near patient 
testing (point of care)'' would be excluded from exemption from 
premarket notification.
    3. One comment stated that in vitro devices ``intended for use in 
screening or diagnosis of familial and acquired genetic disorders 
including inborn errors of metabolism'' (21 CFR 862.1330, 862.1335, 
862.1560, 862.1595, and 862.1650) and test markers for endocrine 
disorders (21 CFR 862.1075, 862.1080, 862.1200, 862.1245, 862.1250, 
862.1260, 862.1265, 862.1270, 862.1275, 862.1280, 862.1285, 862.1300, 
862.1370, 862.1385, 862.1390, 862.1395, and 862.1620) should be subject 
to premarket notification.
    FDA agrees that the manufacturer of the IVD's described by the 
comment may continue to be required to submit 510(k)'s under the 
proposed limitations on exemptions. Proposed limitations in Sec. 862.9 
would assure that these products will be subject to premarket 
notification requirements if intended for use in screening or diagnosis 
of familial or

[[Page 63225]]

acquired genetic disorders or endocrine disorders and will not be 
subject to these requirements where the same device is not intended for 
these specific high risk indications. FDA, therefore, believes that 
these devices should be exempt from premarket notification, subject to 
the limitation.
    4. One comment suggested that premarket notifications and review 
should be required for devices and tests designed to ``identify or 
infer the identity of a microorganism directly from clinical 
materials,'' including devices classified under Secs. 866.3145, 
866.3375, 866.3405, 866.3480, 866.3500 and 866.3740.
    FDA agrees. The comment has described one of the limitations on 
exemptions in the proposed rule. That limitation would apply to a 
number of classifications, including those cited by this comment.
    5. One comment suggested that:
    Quality control material--(assayed and unassayed) ([21 CFR] 
862.1660), must continue to be reviewed so that the FDA oversight 
function may continue to identify those manufacturers of quality 
control reagents whose manufacturing or testing practices could fail 
to ensure a product of appropriate accuracy, stability, and 
reliability.
    FDA agrees that quality control materials are of critical 
importance in laboratory operations. The agency intends to continue to 
review assayed quality control materials because it believes they meet 
the reserved criteria. FDA believes unassayed quality control 
materials, other than those used for donor screening, are appropriate 
for exemption from premarket review. Unlike unassayed quality control 
materials, assayed quality control materials have specifically labeled 
performance levels that are reviewed. The performance of unassayed 
quality control materials that are not labeled is not assessed in the 
510(k) process and is assessed by the laboratory rather than the 
manufacturer. Issues such as stability and reliability for unassayed 
quality control materials are adequately addressed by the new quality 
systems requirements of current good manufacturing practices. Unassayed 
quality control materials for donor screening, however, should not be 
exempt because FDA should review the labeling to ensure no specific 
performance claims are made.
    6. One comment indicated that there is an inconsistency between the 
exemptions of the free tyrosine test system (21 CFR 862.1730) and the 
galactose test system (21 CFR 862.1310), and the limitations on 
exemptions that apply to a device that ``(c) is a in-vitro device that 
is intended: * * * (2) for use in screening or diagnosis of familial 
and acquired genetic disorders, including inborn errors of 
metabolism,'' because all free tyrosine test systems and galactose test 
systems are for those uses. Another comment stated that they were 
confused about the exemption from premarket notification of free 
tyrosine test systems and the limitations on exemptions, as noted 
previously.
    FDA agrees there was an inconsistency. Because the devices are used 
for screening and diagnosis of genetic disorders and are related to 
significant morbidity and mortality associated with the disease 
entities identified by abnormalities in tyrosine and galactose 
metabolism, FDA believes these devices fit within the reserved criteria 
and should be added to the list of reserved class I devices that will 
continue to require premarket notification submissions.
    7. The Health Care Financing Administration (HCFA) raised concerns 
about the effect that exemptions may have on HCFA's implementation of 
the Clinical Laboratory Improvements Amendments (CLIA). HCFA 
subsequently commented that they believed that their concerns could be 
addressed without affecting the exemption process.
    FDA intends to continue to meet with the HCFA staff to address 
these concerns, which relate to inspection procedures in laboratories.
    8. One comment stated that FDA had previously exempted the 
unscented menstrual pad Sec. 884.5435 (21 CFR 884.5435), from premarket 
notification, except for intralabial pads and reusable menstrual pads. 
The comment pointed out that the February 2, 1998, notice did not state 
whether these devices were reserved or exempted. The comment believes 
that FDA meant to exempt them and asked for clarification.
    FDA has evaluated the use of intralabial pads and reusable 
menstrual pads and believes that they do meet the reserved criteria of 
FDAMA. These devices may present a potential unreasonable risk of 
illness or injury due to the risk of vaginal laceration, ulceration, 
vaginal microflora changes, and other possible adverse effects. FDA is, 
therefore, proposing to continue to designate the intralabial pads and 
reusable menstrual pads (Sec. 884.5435) as devices that require 
premarket notification.
    9. One comment stated that FDA should exempt calipers because they 
do not meet the class I reserved criteria of FDAMA.
    FDA concurs and notes that calipers were exempted on April 5, 1989 
(54 FR 13826), under 21 CFR 878.4800 (manual surgical instrument for 
general use), subject to 21 CFR 878.9 limitations of exemptions from 
section 510(k) of the act.
    10. Two comments expressed support for FDA's interpretation of 
section 510(l) of FDAMA and the agency's conclusion that devices 
identified in 21 CFR 874.3300(b)(1), air conduction hearing aids, meet 
the exemption criteria. One comment stated that ``a device will lose 
its exemption if its intended use differs, or if it operates with a 
different fundamental scientific technology.'' The other comment added 
that the society he represented had concerns regarding FDA's 
``vigilance in insisting on adherence to FDA regulation governing the 
labeling and conditions for sale of hearing aids.''
    FDA agrees with the one comment on the scope of the limitations on 
exemptions. As far as FDA regulations governing the labeling, the 
agency believes that general controls are sufficient to regulate air-
conduction hearing aids and that trade complaints will keep the agency 
well informed. The proposed regulation on conditions of sale of hearing 
aids is moving toward publication.
    11. One comment responded to the February 2, 1998, notice by 
submitting a request for classification under section 513(g) of the 
act, requesting information regarding the requirements applicable to a 
dental water filter system with a treated filter/waterline under 21 CFR 
872.6640.
    FDA considers this comment a section 513(g) of the act request and 
will respond to the submitter in an individual response.
    12. One comment requested that the 510(k) the comment submitted for 
a class I device classified under Sec. 884.1040 (21 CFR 884.1040) 
Viscometer for cervical mucus, be found to be exempt from the section 
510(k) requirements of the act. The comment stated that ``the device is 
not intended for a use which is of substantial importance in preventing 
impairment of human health and does not present a potential 
unreasonable risk of illness or injury (``reserved criteria'')'' and 
should not be placed under the reserved criteria found in section 206 
of FDAMA.
    FDA agrees that, generally, viscometers for cervical mucus 
(Sec. 884.1040) do not meet the ``reserved'' criteria under FDAMA and 
did place this classification regulation on the list of exempted 
devices in the February 2, 1998, notice. Consistent with the February 
2, 1998, notice, FDA is proposing to designate viscometers for cervical 
use exempt from 510(k) requirements. The comment's device,

[[Page 63226]]

however, would use a new matrix for this device. FDA believes that this 
represents a different intended use that would make this device subject 
to the limitations on exemptions and, therefore, ineligible for 
exemption.
    13. One comment questioned the limitations on exemptions stated in 
the February 2, 1998, notice, particularly the limitations applicable 
to IVD's that are noninvasive tests. The comment criticized the use of 
the words ``noninvasive testing'' as being overly broad.
    FDA disagrees with this comment. FDA believes that the limitations 
are necessary to assure that devices are not marketed that are 
significantly different from the devices exempted from premarket 
notification, particularly in the area of IVD's where devices are often 
subject to changes in intended use and conditions of use. Noninvasive 
testing devices should not be exempt because they almost always involve 
novel matrices and novel technologies. However, FDA is clarifying the 
phrase, ``noninvasive testing,'' by citing the definition of 
``noninvasive'' found in Sec. 812.3(k) in the proposed limitations on 
exemptions.
    14. One comment suggested that FDA should review the exemptions and 
reservations in existing classifications to assure that the present 
lists are consistent with those listed in the February 2, 1998, notice.
    FDA has reviewed the existing regulations again and is proposing to 
reserve five currently exempted device classifications (Secs. 862.3750, 
862.3850, 870.4200, 886.4750, and 890.1175).
    15. One comment suggested that FDA reserve 11 class I devices that 
FDA stated it considered exempt class I devices in the February 2, 
1998, Federal Register notice and subject them to section 510(k) of the 
act requirements, including: Cultured animal and human cells (21 CFR 
864.2280); Microorganism differentiation and identification device (21 
CFR 866.2660); Coxsackievirus serological reagents (21 CFR 866.3145); 
Echinococcus spp. serological reagents (21 CFR 866.3200); Equine 
encephalomyelitis virus serological reagents (21 CFR 866.3240); 
Lymphocytic choriomeningitis virus serological reagents (21 CFR 
866.3360); Mumps virus serological reagents (21 CFR 866.3380); 
Poliovirus serological reagents (21 CFR 866.3405); Trichinella spiralis 
serological reagents (21 CFR 866.3850); Rickettsia serological reagents 
(21 CFR 866.3500); and Streptococcus spp. serological reagents (21 CFR 
866.3740).
    FDA does not agree with the comment that these devices meet the 
reserved criteria. FDA notes the limitations on exemptions are 
specifically designed to maintain premarket review for devices used in 
``screening, diagnosis, or monitoring life threatening diseases'' or 
``to infer the identity of a microorganism directly from clinical 
material.'' While section 510(k) of the act exemptions would apply to 
devices marketed for uses the agency would consider lower risk, such as 
determination of immune status or for epidemiological uses of these 
devices, they would not apply to devices with diagnostic claims for use 
in life-threatening disease states or for direct detection of a 
microorganism using clinical material. Therefore, FDA is proposing to 
designate these 11 devices as exempt from section 510(k) of the act 
requirements subject to the limitations on exemptions.
    16. One comment suggested that the limitations on exemptions are 
unnecessary, confusing, and difficult to apply, especially to IVD's. 
This comment additionally notes ``we question the basis for FDA's broad 
restrictions in such a specific category of devices.''
    FDA does not agree that the language is unnecessary, confusing, or 
difficult to apply. The limitations language that was in the February 
2, 1998, Federal Register notice, and that is proposed for all class I 
devices modifies the limitations on exemptions currently found in 
Sec. ______.9 of each device classification regulation part (e.g., 
Secs. 862.9, 864.9, etc.) only in three ways. First, FDA has referenced 
class II devices to reflect that both class I and class II devices may 
be exempted in accordance with new section 510(l) and (m). Second, the 
limitations language modifies current limitations language by stating 
that devices are to be compared to ``any legally marketed device in 
that generic type of device'' rather than a device on the market 
``before May 28, 1976'' or a ``preamendments device to which it has 
been determined substantially equivalent.'' Third, the limitations 
language adds specific language relating to IVD's. The agency cannot 
predict all possible different intended uses or changes in fundamental 
scientific technologies that may significantly affect safety and 
effectiveness; limitations on exemptions are, therefore, in the best 
interest of the public health because they ensure that devices 
incorporating such changes will be reviewed for safety and 
effectiveness by the agency before they go to market.
    In order to efficiently allocate review resources, the agency has 
developed a risk-based approach toward use of the limitations on 
exemptions to ensure that high-risk devices remain subject to premarket 
review. The limitations on exemptions continue to take into account two 
critical risk elements--intended use and novelty of technology.
    Furthermore, FDA believes that in vitro diagnostic devices are 
unique because their safety and effectiveness relates primarily to the 
information generated by these devices rather than the direct 
interaction between device and patient. FDA has more fully discussed 
the need for these limitations earlier in this document.
    17. One comment believed the limitations on exemptions required 
clarification as follows:
    With regard to the first limitation (``has an intended use that 
is different from the intended use of a legally marketed device in 
that generic type''), we believe that current law is clear that if a 
device has an intended use different than that expressed in the 
definition contained in the Code of Federal Regulations (CFR), such 
device would not be the same as the exempted device. The exemption 
would simply not apply to that device. However, ``intended use'' can 
encompass many different concepts that go beyond the general 
intended use statements that comprised the CFR definitions. There 
has been some controversy, for instance, over the extent to which 
indications for use can change intended use. Our position is that 
any indication for use that has been included in a previous 510(k) 
order of classification identifies the scope of the intended use for 
each exempt type of device. Minor variances of indications for use 
within the intended use of an exempt type of device should have no 
effect on the status of a 510(k) exemption.
    FDA has interpreted Sec. ______.9(a) in the limitations on 
exemptions under the current regulations to mean that any legally 
marketed device (as defined in 21 CFR 807.92(a)(3)) within a device 
classification regulation may serve as a predicate for another 
manufacturer's device and the other manufacturer's device may be 
exempt. FDA believes that any additional indication for use for an 
exempt classification device type (i.e., an indication not previously 
cleared) is considered a different intended use and does not meet the 
limitations on exemptions, and therefore, requires a new premarket 
notification. FDA agrees that minor variances in indications would not 
affect the exemption status of the classification. FDA notes that in 
its guidance entitled ``Deciding When to Submit a 510(k) for a Change 
to an Existing Device,'' FDA states, in regard to minor variances in 
indications of closely related populations, ``If the expansion is to a 
population with similar demographics, diagnosis, prognosis, comorbidity 
and potential for complications as the original, then a new 510(k) is 
not ordinarily expected.''

[[Page 63227]]

    18. On its own initiative, FDA is proposing to require premarket 
notification for five devices that are currently exempt from premarket 
notification: Quinine test system (Sec. 862.3750), sulfonamide test 
system (Sec. 862.3850), cardiopulmonary bypass accessory equipment 
(Sec. 870.4200), electrode cable (Sec. 890.1175), and ophthalmic eye 
shield (when made of other than plastic or aluminum) (Sec. 886.4750).

IV. FDA Proposal to Revoke Exemptions

A. Quinine Test System (Sec. 862.3750) and Sulfonamide Test System 
(Sec. 862.3850)

    On June 8, 1988 (53 FR 21447), FDA published a final rule exempting 
the quinine test system and the sulfonamide test system from premarket 
notification requirements. FDA stated that it was exempting these 
products because it believed that premarket notification was not 
necessary to protect the public health.
    The quinine test system is used to measure quinine, a fever-
reducing and pain-relieving drug used to treat malaria, in the serum or 
urine. Measurements obtained by this device are used in the diagnosis 
and treatment of quinine overdose and malaria. If this device fails, 
persons who have malaria may suffer serious life-threatening 
consequences by not receiving the appropriate amount of quinine. 
Similarly, the sulfonamide test system is intended to measure 
sulfonamide levels which are used to treat life-threatening bacterial 
infections. The failure of this device may also result in the improper 
treatment of a life-threatening disease.
    Given that these devices are used in determining the treatments for 
life-threatening diseases, and an inaccurate measurement of the 
treatment drug could result in life-threatening consequences, FDA does 
not believe that its previous determinations to exempt these devices 
from premarket notification were correct. Accordingly, FDA believes 
that premarket review is necessary to assure the safety and 
effectiveness of these devices. Moreover, FDA believes that these 
products meet the reserved criteria for premarket review under section 
510(l), in that they are intended for a use which is of substantial 
importance in preventing impairment of human health, and present a 
potential unreasonable risk of illness or injury. Therefore, FDA is 
proposing to require manufacturers of these products to submit 
premarket notifications.

B. Ophthalmic Eye Shields (Sec. 886.4750)

    On September 2, 1987 (52 FR 33366), FDA published a final rule 
classifying ophthalmic eye shields as class I devices. This generic 
type of device is described in Sec. 886.4750 as ``a device that 
consists of a plastic or aluminum eye covering intended to protect the 
eye or retain dressing materials in place.'' Plastic or aluminum eye 
shields rest over the forehead and cheek and do not contact the eye.
    Since that classification, FDA has found eye shields that are made 
of collagen substantially equivalent to eye shields made out of plastic 
or aluminum in Sec. 886.4750. Collagen eye shields, unlike aluminum and 
plastic eye shields, come in direct contact with the cornea and are 
indicated for relief of discomfort from post-surgical, traumatic and 
nontraumatic corneal conditions. Unlike aluminum and plastic eye 
shields, there are toxicological concerns relating to biocompatibility 
and dissolving time for collagen materials. In premarket reviews, FDA 
has examined biocompatibility and dissolving issues in determining the 
substantial equivalence of collagen eye shields to plastic and aluminum 
eye shields.
    On December 7, 1994 (59 FR 63005), FDA published a final rule 
exempting this classification from premarket notification requirements, 
and quality systems requirements, except 21 CFR 820.198, with respect 
to complaint files. FDA erred in not amending the codified language at 
that time to retain premarket review and quality system requirements 
for collagen eye shields that had been placed in that classification. 
Despite the exemption language, FDA has continued to receive and review 
premarket notifications for eye shields made out of collagen.
    Because the toxicological issues cause the product to meet the 
reserved criteria in that the devices are intended for a use which is 
of substantial importance in preventing impairment of human health or 
present a potential unreasonable risk of illness or injury, FDA is 
proposing to amend the codified text to state that collagen eye shields 
are not exempt from premarket notification requirements.

C. Cardiopulmonary Bypass Accessory Equipment (Sec. 870.4200) and 
Electrode Cable (Sec. 890.1175)

    On June 12, 1989 (54 FR 25042), FDA published a final rule 
exempting electrode cables (Sec. 890.1175) and cardiopulmonary bypass 
accessory equipment (Sec. 870.4200) from premarket notification 
requirements. FDA received numerous reports of deaths and injuries 
associated with unprotected patient cables and lead wires. To address 
the risk of patient exposure to macro shock or electrocution due to the 
inappropriate connection of a patient connected cable or electrode lead 
wire to an alternating current power source, in the Federal Register of 
May 9, 1997 (62 FR 25477), FDA published a final rule establishing a 
performance standard for cables and leads. In the preamble of that 
final rule, FDA announced that it intended to reclassify electrode 
cables (Sec. 890.1175) and cardiopulmonary bypass accessory equipment 
(Sec. 870.4200) to class II to subject them to this performance 
standard. In the meantime, FDA is proposing to subject these devices to 
premarket review to assure that they are safe and effective, pending 
the rulemaking to reclassify them into class II.

V. Proposed Designation of Devices

    In the Federal Register of February 2, 1998 (63 FR 5387), FDA 
issued a notice of its intent to propose to exempt a list of class I 
(general controls) devices from the requirement of premarket 
notification, subject to the limitations of exemptions. FDA has 
reviewed that list and other devices in light of the comments received 
in response to the February 2, 1998, notice and other information that 
has come to FDA's attention. As a result, FDA is proposing to designate 
as exempt certain devices that were not listed as exempt in the 
February 2, 1998, notice and to designate as reserved devices certain 
devices that were not designated as reserved in the February 2, 1998, 
notice or that were previously exempted by regulation.
    The following devices are devices that FDA believes meet the 
reserved criteria in section 206 of FDAMA and, therefore, FDA is 
proposing to designate that they remain subject to premarket 
notification under new section 510(l) added to the act:

[[Page 63228]]



                           Table 1.--Proposed Designations of 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
862.1310                                         Galactose 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
862.1730                                          Free tyrosine test system
862.1775                                         Uric acid test system
862.3050                                         Breath-alcohol test system
862.3110                                         Antimony test system
862.3120                                          Arsenic test system
862.3220                                         Carbon monoxide test system
862.3240                                         Cholinesterase test system
862.3280                                         Clinical toxicology control material (assayed and unassayed)1
862.3600                                          Mercury test system
862.3750                                          Quinine test system
862.3850                                          Sulfonamide 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 system2
864.9195                                         Blood mixing devices and blood weighing devices2
866.2390                                         Transport culture medium
866.2560                                         Microbial growth monitor3
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
870.4200                                         Cardiopulmonary bypass accessory equipment
872.3700                                         Dental mercury
872.4200                                         Dental handpiece and accessories
872.6250                                         Dental chair and accessories4
872.6640                                         Dental operative unit and accessories5
872.6710                                         Boiling water sterilizer
876.5160                                         Urological clamps for males6
878.4460                                         Surgeon's glove
880.5090                                         Liquid bandage7
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 cannula8
882.4545                                         Shunt system implantation instrument9
884.2980(a)                                      Telethermographic system10
884.2982(a)                                      Liquid crystal thermographic system11
884.5435                                         Unscented menstrual pads (intralabial pads and reusable
                                                  menstrual pads)
886.4070                                         Powered corneal burr12
886.4300                                         Intraocular lens guide13
886.4370                                         Keratome
886.4750                                         Ophthalmic eye shield (when made of other than plastic or
                                                  aluminum)
888.1500                                         Goniometer
890.1175                                         Electrode cable
890.3850                                         Mechanical wheelchair
890.5710                                         Hot or cold disposable pack14
892.1100                                         Scintillation (gamma) camera
892.1110                                         Positron camera
----------------------------------------------------------------------------------------------------------------
\1\ Meets reserved criteria for all assayed and only the 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 an accessory to the unit.
\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.

[[Page 63229]]

\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 intraocular lenses (IOL's).
\14\ Meets reserved criteria if indicated for use on infants.

    FDA is proposing to amend the regulations to designate the 
following devices as exempt from premarket notification because FDA 
believes that they do not meet the reserved criteria under section 206 
of the FDAMA that adds new section 510(l) of the act:

                           Table 2.--Proposed Designations of 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
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                                         Estrogens (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
862.1325                                          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 system
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
862.1610                                         Pregnanetriol test system
862.1615                                         Pregnenolone test system
862.1620                                         Progesterone test system
862.1625                                         Prolactin (lactogen) test system

[[Page 63230]]

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
862.1780                                         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
862.2900                                         Automated urinalysis system
862.3280                                         Clinical toxicology control material (assayed and unassayed)1
864.2280                                         Cultured animal and human cells
864.3250                                         Specimen transport and storage container
864.5240                                         Automated blood cell diluting apparatus
864.6150                                         Capillary blood collection tube
864.9125                                         Vacuum-assisted blood collection system2
864.9185                                         Blood grouping view box
864.9195                                         Blood mixing devices and blood weighing devices2
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 determinations
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 schenckii 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
866.5330                                         Factor XIII, A, S, immunological test system3
866.5400                                         Alpha-globulin immunological test system
866.5420                                         Alpha-1-glycoproteins immunological test system
866.5425                                         Alpha-2-glycoproteins immunological test system
866.5430                                         Beta-2-glycoprotein I immunological test system
866.5440                                         Beta-2-glycoprotein III immunological test system

[[Page 63231]]

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 system4
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
872.3275(a)(1)                                   Dental cement (zinc oxide-eugenol)
872.3400(b)(1)                                   Karaya and sodium borate with or without acacia denture
                                                  adhesive (less than 12 percent sodium borate by weight)
872.3540(b)(1)                                   OTC denture cushion or pad5
872.6300                                         Rubber dam6
872.6390                                         Dental floss
874.1070                                         Short increment sensitivity index (SISI) adapter
874.1100                                         Earphone cushion for audiometric testing
874.1500                                         Gustometer
874.1800                                         Air or water caloric stimulator
874.1925                                         Toynbee diagnostic tube
874.3300(b)(1)                                   Hearing aid6
874.3540                                         Prosthesis modification instrument for ossicular replacement
                                                  surgery
874.4100                                         Epistaxis balloon
874.4420                                         Ear, nose, and throat manual surgical instrument
874.5300                                         Ear, nose, and throat examination and treatment unit
874.5550                                         Powered nasal irrigator
874.5840                                         Antistammering device
876.5160                                         Urological clamp for males7
876.5210                                         Enema kit
876.5250(b)(2)                                   Urine collector and accessories8
876.5980(b)(2)                                   Gastrointestinal tube and accessories9
878.3250                                         External facial fracture fixation appliance
878.3910                                         Noninflatable extremity splint
878.3925                                         Plastic surgery kit and accessories
878.4040                                         Surgical apparel10
878.4100                                         Organ bag
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 chairs and
                                                  accessories
880.5090                                         Liquid bandage11
880.5270                                         Neonatal eye pad
880.5420                                         Pressure infusor for an I.V. bag
882.1200                                         Two-point discriminator
882.1500                                         Esthesiometer
882.1750                                         Pinwheel
882.4060                                         Ventricular cannula12
882.4545                                         Shunt system implantation instrument13
882.4650                                         Neurosurgical suture needle
882.4750                                         Skull punch14
884.1040                                         Viscometer for cervical mucus
886.1780                                         Retinoscope15
886.1940                                         Tonometer sterilizer
886.4070                                         Powered corneal burr16
886.4300                                         Intraocular lens guide17
886.5850                                         Sunglasses (nonprescription
890.5180                                         Manual patient rotation bed
890.5710                                         Hot or cold disposable pack18
892.1300                                         Nuclear rectilinear scanner
892.1320                                         Nuclear uptake probe
892.1330                                         Nuclear whole body scanner
892.1350                                         Nuclear scanning bed
892.1410                                         Nuclear electrocardiograph synchronizer
892.1890                                         Radiographic film illuminator
892.1910                                         Radiographic grid
892.1960                                         Radiographic intensifying screen

[[Page 63232]]

892.1970                                         Radiographic ECG/respirator, synchronizer
892.2010                                         Medical image storage device
892.2020                                         Medical image communication device
892.5650                                         Manual radionuclide applicator system
892.6500                                         Personnel protective shield
----------------------------------------------------------------------------------------------------------------
\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 21 CFR 864.7290.
\4\ This exemption should not be confused with 21 CFR 864.5425 or 864.7750.
\5\ This exemption does not apply to class III OTC denture cushion as described in 21 CFR 872.3540(b)(2).
\6\ Exemption does not include rubber dam intended for use in preventing transmission of sexually transmitted
  diseases through oral sex. Those devices are classified as condoms in Sec.  884.5300.
\7\ Exemption is limited to air-conduction hearing aids.
\8\ Exemption does not include devices for internal use or devices used for females.
\9\ Exemption does not include class II devices for a urine collector and accessories intended to be connected
  to an indwelling catheter as described in 21 CFR 876.5250(b)(1).
\10\ Exemption is limited to dissolvable nasogastric feed tube guide for the nasogastric tube in Sec.
  876.5980(b)(2) (21 CFR 876.5980(b)(2)). Exemption does not include class II devices as described in Sec.
  876.5980(b)(1).
\11\ Exemption is limited to class I category other than surgical gowns and surgical masks.
\12\ Exemption is limited to uses as a skin protectant.
\13\ Exemption is limited to devices made of surgical grade stainless steel.
\14\ Exemption is limited to devices made of surgical grade stainless steel.
\15\ Exemption should not be confused with 21 CFR 882.4305.
\16\ Exemption is limited to class I battery-powered devices.
\17\ Exemption is limited to rust ring removal.
\18\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.

VI. Differences Between the February 2, 1998, List of Exempt and 
Reserved Devices, and List of Exempt and Reserved Devices Proposed 
Herein

    As stated previously, FDA issued a notice on February 2, 1998, in 
the Federal Register that listed the devices that it considered exempt 
from 510(k) requirements (exempt), and those it considered subject to 
510(k) requirements (reserved) under new section 510(l). This document 
proposes to designate the reserved and exempt lists by notice and 
comment rulemaking. Although most of the device categories listed in 
the February 2, 1998, notice, and the device categories listed in this 
proposal are identical, there are a few differences. These differences 
are described in the following lists:

                  Table 3.--Proposed Reserved Devices That Are Currently Exempted by Regulation
----------------------------------------------------------------------------------------------------------------
                 21 CFR Section                                           Name of Device
----------------------------------------------------------------------------------------------------------------
862.3750                                         Quinine test system
862.3850                                         Sulfonamide test system
870.4200                                         Cardiopulmonary bypass accessory equipment
886.4750                                         Ophthalmic eye shield (when made of other than plastic or
                                                  aluminum)
890.1175                                         Electrode cable
----------------------------------------------------------------------------------------------------------------


   Table 4.--Additional Proposed Reserved Devices Not Considered Reserved Under the February 2, 1998, Federal
                                                 Register Notice
----------------------------------------------------------------------------------------------------------------
                 21 CFR Section                                           Name of Device
----------------------------------------------------------------------------------------------------------------
862.3050                                         Breath alcohol test system
872.3700                                         Dental Mercury
884.5435                                         Unscented menstrual pads (intralabial pads and reusable
                                                  menstrual pads)
----------------------------------------------------------------------------------------------------------------


Table 5.--Additional Proposed Exempted Devices Not Considered Exempted in the February 2, 1998, Federal Register
                                                     Notice
----------------------------------------------------------------------------------------------------------------
                 21 CFR Section                                           Name of Device
----------------------------------------------------------------------------------------------------------------
864.3250                                         Specimen transport and storage container (OTC)
864.6150                                         Capillary blood collection tube
872.3275(a)(1)                                   Dental cement (zinc oxide-eugenol)
872.3540(b)(1)                                   OTC dental cushion or pad (wax impregnated cotton cloth)
872.6300                                         Rubber dam
874.1100                                         Earphone cushion for audiometric testing
874.3540                                         Prosthesis modification instrument for ossicular replacement
                                                  surgery
874.4420                                         Ear, nose, and throat manual surgical instrument
876.5980(b)(2)                                   Gastrointestinal tube and accessories (dissolvable nasogastric
                                                  feed tube guide for the nasogastric tube)

[[Page 63233]]

878.3250                                         External facial fracture appliance
878.3910                                         Noninflatable extremity splint
878.3925                                         Plastic surgery kit and accessories
878.4100                                         Organ bag
882.1200                                         Two point discriminator
882.1500                                         Esthesiometer
882.1750                                         Pinwheel
892.1350                                         Nuclear scanning bed
892.2010                                         Medical image storage device
892.2020                                         Medical image communication device
892.6500                                         Personnel protective shield
----------------------------------------------------------------------------------------------------------------

VII. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that these proposed 
actions are of a type that do not individually or cumudatave a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VIII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). 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, if a rule has a 
significant impact on a substantial number of small entities, agencies 
to analyze regulatory options that would minimize any significant 
impact of a rule on small entities. In most cases, the proposed rule 
would reduce a regulatory burden by exempting manufacturers of devices 
subject to the rule from the requirements of premarket notification.
    FDA is proposing to require premarket notification for 5 devices 
that were previously exempt from premarket notification. These devices 
are as follows:

A. Cardiopulmonary Bypass Accessory Equipment (Sec. 870.4200) and 
Electrode Cable (Sec. 890.1175).

     In the Federal Register of May 9, 1997 (62 FR 25477), FDA 
published a final rule to establish a performance standard for 
electrode lead wires and patient cables. In the preamble to that rule 
(62 FR 25485), FDA noted that three unprotected cable and electrode 
lead wire systems are included in class I devices, and, as such, are 
not subject to a mandatory performance standard. These include the two 
devices listed previously and the AC-powered goniometer (21 CFR 
888.1500). FDA further stated that, because of the degree of health 
risk, the agency intended to reclassify the devices into class II so 
that they would be subject to the mandatory performance standard. The 
cardiopulmonary bypass accessory equipment and the electrode cable were 
already exempt from premarket notification; the AC-powered goniometer 
was not. Because of the degree of health risk, FDA believes that these 
devices should be designated as reserved devices.
    FDA also included in the preamble of the May 9, 1997, rule an 
assessment of the economic impact of imposition of the standard 
including an assessment of its effect on small businesses. In this 
assessment, FDA included the three class I devices to which the rule 
would later apply. FDA concluded that the rule would not have a 
significant economic impact on a substantial number of small entities. 
This rule would only impose the additional requirement of submitting a 
premarket notification for these devices. Because the premarket 
notification would consist primarily of a certification of compliance 
with the cables and leads standard, FDA believes that this requirement 
will not be a significant burden.

B. Ophthalmic Eye Shield (When Made of Other than Plastic or Aluminum) 
(Sec. 886.4750).

     There are six manufacturers of ophthalmic eye shields other than 
those made of plastic or aluminum registered with FDA. FDA anticipates 
that any premarket notifications that are necessary for these devices 
would be simple. FDA would be primarily interested in the 
biocompatibility of the devices. FDA estimates that preparation of such 
a premarket notification would cost no more than $5,000.

C. Quinine Test System (Sec. 862.3750) and Sulfonamide test system 
(Sec. 862.3850).

     At this time, there are no firms registered for manufacture of 
these devices.
    In light of the previous discussion under the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), the agency certifies that the final 
rule will not have a significant economic impact on a substantial 
number of small entities. The rule also does not trigger the 
requirement for a written statement under section 202(a) of the 
Unfunded Mandates Reform Act because it does not impose a mandate that 
results in an expenditure of $100 million or more by State, local, or 
tribal governments in the aggregate, or by the private sector, in any 1 
year.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

X. Comments

    Interested persons may, on or before January 26, 1999, 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.

[[Page 63234]]

 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 864

    Blood, Medical devices, Packaging and containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 892

    Medical devices, Radiation protection, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA is 
proposing to amend 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 
878, 880, 882, 884, 886, 888, 890, and 892 as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 862.9 is revised to read as follows:


Sec. 862.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
     (3) 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;
     (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    3. Section 862.1030 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1030   Alanine amino transferase (ALT/SGPT) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    4. Section 862.1040 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1040   Aldolase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    5. Section 862.1060 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1060   Delta-aminolevulinic acid test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from premarket notification procedures in subpart E of part 807 
of this chapter subject to Sec. 862.9.
    6. Section 862.1075 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1075   Androstenedione test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    7. Section 862.1080 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1080   Androsterone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    8. Section 862.1095 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1095   Ascorbic acid test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    9. Section 862.1115 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1115   Urinary bilirubin and its conjugates (nonquantitative) 
test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    10. Section 862.1130 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1130   Blood volume test system.

* * * * *

[[Page 63235]]

    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    11. Section 862.1135 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1135   C-peptides of proinsulin test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    12. Section 862.1165 is amended by revising paragraph (b) to read 
follows:


Sec. 862.1165   Catecholamines (total) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    13. Section 862.1175 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1175   Cholesterol (total) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    14. Section 862.1180 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1180   Chymotrypsin test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    15. Section 862.1185 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1185   Compound S (11-deoxycortisol) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    16. Section 862.1195 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1195   Corticoids test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    17. Section 862.1200 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1200   Corticosterone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    18. Section 862.1240 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1240   Cystine test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    19. Section 862.1245 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1245   Dehydroepiandrosterone (free and sulfate) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    20. Section 862.1250 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1250   Desoxycorticosterone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    21. Section 862.1260 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1260   Estradiol test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    22. Section 862.1265 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1265   Estriol test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    23. Section 862.1270 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1270   Estrogens (total, in pregnancy) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    24. Section 862.1275 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1275   Estrogens (total, nonpregnancy) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    25. Section 862.1280 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1280   Estrone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    26. Section 862.1285 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1285   Etiocholanolone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    27. Section 862.1300 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1300   Follicle-stimulating hormone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    28. Section 862.1325 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1325   Gastrin test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    29. Section 862.1330 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1330   Globulin test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    30. Section 862.1335 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1335   Glucagon test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in

[[Page 63236]]

subpart E of part 807 of this chapter subject to Sec. 862.9.
    31. Section 862.1360 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1360   Gamma-glutamyl transpeptidase and isoenzymes test 
system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    32. Section 862.1370 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1370   Human growth hormone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    33. Section 862.1375 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1375   Histidine test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    34. Section 862.1385 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1385   17-Hydroxycorticosteroids (17-ketogenic steroids) test 
system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    35. Section 862.1390 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1390   5-Hydroxyindole acetic acid/serotonin test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    36. Section 862.1395 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1395   17-Hydroxyprogesterone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    37. Section 862.1400 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1400   Hydroxyproline test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    38. Section 862.1405 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1405   Immunoreactive insulin test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    39. Section 862.1430 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1430   17-Ketosteroids test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    40. Section 862.1435 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1435   Ketones (nonquantitative) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    41. Section 862.1450 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1450   Lactic acid test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    42. Section 862.1460 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1460   Leucine aminopeptidase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    43. Section 862.1465 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1465   Lipase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    44. Section 862.1475 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1475   Lipoprotein test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    45. Section 862.1485 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1485   Luteinizing hormone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    46. Section 862.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1500   Malic dehydrogenase test system.

* * * * *
     (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    47. Section 862.1505 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1505   Mucopolysaccharides (nonquantitative) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    48. Section 862.1510 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1510   Nitrite (nonquantitative) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    49. Section 862.1520 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1520   5'-Nucleotidase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    50. Section 862.1530 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1530   Plasma oncometry test system.

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

[[Page 63237]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 862.9.
    51. Section 862.1535 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1535   Ornithine carbamyl transferase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    52. Section 862.1540 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1540   Osmolality test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    53. Section 862.1542 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1542   Oxalate test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    54. Section 862.1550 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1550   Urinary pH (nonquantitative) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    55. Section 862.1560 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1560   Urinary phenylketones (nonquantitative) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    56. Section 862.1570 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1570   Phosphohexose isomerase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    57. Section 862.1590 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1590   Porphobilinogen test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    58. Section 862.1595 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1595   Porphyrins test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    59. Section 862.1605 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1605   Pregnanediol test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    60. Section 862.1610 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1610   Pregnanetriol test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    61. Section 862.1615 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1615   Pregnenolone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    62. Section 862.1620 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1620   Progesterone test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    63. Section 862.1625 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1625   Prolactin (lactogen) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    64. Section 862.1630 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1630   Protein (fractionation) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    65. Section 862.1645 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1645   Urinary protein or albumin (nonquantitative) test 
system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    66. Section 862.1650 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1650   Pyruvate kinase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    67. Section 862.1655 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1655   Pyruvic acid test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    68. Section 862.1660 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1660   Quality control material (assayed and unassayed).

* * * * *
    (b) Classification. Class I (general controls). Except when used in 
donor screening tests, unassayed material is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 862.9.
    69. Section 862.1705 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1705   Triglyceride test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    70. Section 862.1725 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1725   Trypsin test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[[Page 63238]]

    71. Section 862.1780 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1780   Urinary calculi (stones) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    72. Section 862.1785 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1785   Urinary urobilinogen (nonquantitative) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    73. Section 862.1790 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1790   Uroporphyrin test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    74. Section 862.1795 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1795   Vanilmandelic acid test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    75. Section 862.1805 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1805   Vitamin A test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    76. Section 862.1820 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1820   Xylose test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    77. Section 862.2140 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2140   Centrifugal chemistry analyzer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    78. Section 862.2150 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2150   Continuous flow sequential multiple chemistry analyzer 
for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    79. Section 862.2160 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2160   Discrete photometric chemistry analyzer for clinical 
use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    80. Section 862.2170 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2170   Micro chemistry analyzer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    81. Section 862.2250 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2250   Gas liquid chromatography system for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    82. Section 862.2260 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2260   High pressure liquid chromatography system for clinical 
use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    83. Section 862.2270 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2270   Thin-layer chromatography system for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9. Particular components of TLC 
systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, 
TLC developing tanks, and TLC ultraviolet light, are exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.
    84. Section 862.2300 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2300   Colorimeter, photometer, or spectrophotometer for 
clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    85. Section 862.2400 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2400   Densitometer/scanner (integrating, reflectance, TLC, or 
radiochromatogram) for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    86. Section 862.2500 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2500   Enzyme analyzer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    87. Section 862.2540 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2540   Flame emission photometer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    88. Section 862.2560 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2560   Fluorometer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    89. Section 862.2680 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2680   Microtitrator for clinical use.

* * * * *

[[Page 63239]]

    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    90. Section 862.2700 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2700   Nephelometer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    91. Section 862.2730 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2730   Osmometer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    92. Section 862.2750 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2750   Pipetting and diluting system for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    93. Section 862.2850 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2850   Atomic absorption spectrophotometer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    94. Section 862.2860 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2860   Mass spectrometer for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    95. Section 862.2900 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2900   Automated urinalysis system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    96. Section 862.3280 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.3280   Clinical toxicology control material.

* * * * *
    (b) Classification. Class I (general controls). Except when used in 
donor screening, unassayed material is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 862.9.
    97. Section 862.3750 is amended by revising paragraph (b) to read 
as follows:


Sec.  862.3750   Quinine test system.

* * * * *
    (b) Classification. Class I.
    98. Section 862.3850 is amended by revising paragraph (b) to read 
as follows:


Sec.  862.3850   Sulfonamide test system.

* * * * *
    (b) Classification. Class I.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    99. The authority citation for 21 CFR part 864 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    100. Section 864.9 is revised to read as follows:


Sec.  864.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
     (3) 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;
     (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
     (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
     (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    101. Section 864.2280 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2280   Cultured animal and human cells.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    102. Section 864.3250 is amended by revising paragraph (b) to read 
as follows:


Sec.  864.3250   Specimen transport and storage container.

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

[[Page 63240]]

subject to Sec. 864.9. If the device is not labeled or otherwise 
represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.
    103. Section 864.5240 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.5240   Automated blood cell diluting apparatus.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    104. Section 864.6150 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.6150   Capillary blood collection tube.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    105. Section 864.9125 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9125   Vacuum-assisted blood collection system.

* * * * *
    (b) Classification. Class I (general controls). The manual device 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to Sec. 864.9.
    106. Section 864.9185 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9185   Blood grouping view box.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    107. Section 864.9195 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9195   Blood mixing devices and blood weighing devices.

* * * * *
    (b) Classification. Class I (general controls). The manual device 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to Sec. 864.9.
    108. Section 864.9225 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9225   Cell-freezing apparatus and reagents for in vitro 
diagnostic use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    109. Section 864.9275 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9275   Blood bank centrifuge for in vitro diagnostic use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    110. Section 864.9320 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9320   Copper sulfate solution for specific gravity 
determinations.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    111. Section 864.9750 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9750   Heat-sealing device.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    112. The authority citation for 21 CFR part 866 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    113. Section 866.9 is revised to read as follows:


Sec.  866.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
     (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    114. Section 866.2660 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2660   Microorganism differentiation and identification 
device.

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

[[Page 63241]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 866.9.
    115. Section 866.3040 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3040   Aspergillus spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    116. Section 866.3140 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3140   Corynebacterium spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    117. Section 866.3145 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3145   Coxsackievirus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    118. Section 866.3200 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3200   Echinococcus spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    119. Section 866.3240 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3240   Equine encephalomyelitis virus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    120. Section 866.3355 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3355   Listeria spp. serological reagents.

* * * * *
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    121. Section 866.3360 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3360   Lymphocytic choriomeningitis virus serological 
reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    122. Section 866.3375 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3375   Mycoplasma spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    123. Section 866.3380 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3380   Mumps virus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    124. Section 866.3405 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3405   Poliovirus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    125. Section 866.3480 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3480   Respiratory syncytial virus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    126. Section 866.3500 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3500   Rickettsia serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    127. Section 866.3600 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3600   Schistosoma spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    128. Section 866.3680 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3680   Sporothrix schenckii serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    129. Section 866.3740 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3740   Streptococcus spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    130. Section 866.3850 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3850   Trichinella spiralis serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    131. Section 866.5060 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5060   Prealbumin immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    132. Section 866.5065 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5065   Human allotypic marker immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    133. Section 866.5160 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5160   Beta-globulin immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    134. Section 866.5200 is amended by revising paragraph (b) to read 
as follows:

[[Page 63242]]

Sec. 866.5200   Carbonic anhydrase B and C immunological test system.

* * * * *
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    135. Section 866.5330 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5330   Factor XIII, A, S, immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9. This exemption does not 
apply to factor deficiency tests classified under Sec. 864.7290 of this 
chapter.
    136. Section 866.5400 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5400   Alpha-globulin immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    137. Section 866.5420 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5420   Alpha-1-glycoproteins immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    138. Section 866.5425 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5425   Alpha-2-glycoproteins immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    139. Section 866.5430 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5430   Beta-2-glycoprotein I immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    140. Section 866.5440 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5440   Beta-2-glycoprotein III immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    141. Section 866.5560 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5560   Lactic dehydrogenase immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    142. Section 866.5570 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5570   Lactoferrin immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    143. Section 866.5590 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5590   Lipoprotein X immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    144. Section 866.5715 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5715   Plasminogen immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    145. Section 866.5735 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5735   Prothrombin immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9. This exemption does not 
apply to multipurpose systems for in vitro coagulation studies 
classified under Sec. 864.5425 of this chapter or prothrombin time 
tests classified under Sec. 864.7750 of this chapter.
    146. Section 866.5765 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5765   Retinol-binding protein immunological test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    147. Section 866.5890 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5890   Inter-alpha trypsin inhibitor immunological test 
system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

PART 868--ANESTHESIOLOGY DEVICES

    148. The authority citation for 21 CFR part 868 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    149. Section 868.9 is revised to read as follows:


Sec.  868.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific

[[Page 63243]]

technology than a legally marketed device in that generic type of 
device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
     (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
     (7) 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;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
     (9) For near patient testing (point of care).
    150. Section 868.1910 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1910   Esophageal stethoscope.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 868.9.
    151. Section 868.5620 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5620   Breathing mouthpiece.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 868.9.
    152. Section 868.5640 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5640   Medicinal nonventilatory nebulizer (atomizer).

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 868.9.
    153. Section 868.5675 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5675   Rebreathing device.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 868.9.
    154. Section 868.5700 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5700   Nonpowered oxygen tent.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 868.9.
    155. Section 868.6810 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6810   Tracheobronchial suction catheter.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 868.9.

PART 870--CARDIOVASCULAR DEVICES

    156. The authority citation for 21 CFR part 870 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    157. Section 870.9 is revised to read as follows:


Sec.  870.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
     (3) 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;
    (4) For assessing the risk of cardiovascular diseases;
     (5) For use in diabetes management;
     (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
     (9) For near patient testing (point of care).
    158. Section 870.4200 is amended by revising paragraph (b) to read 
as follows:

[[Page 63244]]

Sec.  870.4200   Cardiopulmonary bypass accessory equipment.

* * * * *
    (b) Classification. Class I.

PART 872--DENTAL DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    160. Section 872.9 is revised to read as follows:


Sec.  872.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
     (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
     (3) 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;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
     (9) For near patient testing (point of care).
    161. Section 872.3275 is amended by revising paragraph (a)(2) to 
read as follows:


Sec. 872.3275   Dental cement.

    (a) * * *
    (2) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 872.9.
* * * * *
    162. Section 872.3400 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 872.3400   Karaya and sodium borate with or without acacia denture 
adhesive.

* * * * *
    (b) Classification. (1) Class I (general controls) if the device 
contains less than 12 percent by weight of sodium borate. The class I 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to Sec. 872.9.
* * * * *
    163. Section 872.3540 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 872.3540   OTC denture cushion or pad.

* * * * *
    (b) Classification. (1) Class I if the device is made of wax-
impregnated cotton cloth that the patient applies to the base or inner 
surface of a denture before inserting the denture into the mouth. The 
device is intended to be discarded following 1 day's use. The class I 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to Sec. 872.9.
* * * * *
    164. Section 872.6300 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6300   Rubber dam and accessories.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 872.9. If the device is not labeled 
or otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.
    165. Section 872.6390 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6390   Dental floss.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 872.9.
    166. Section 872.6640 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6640   Dental operative unit and accessories.

* * * * *
    (b) Classification. Class I (general controls). Except for dental 
operative unit, accessories are exempt from premarket notification 
procedures in subpart E of part 807 of this chapter subject to 
Sec. 872.9.

PART 874--EAR, NOSE, AND THROAT DEVICES

    167. The authority citation for 21 CFR part 874 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    168. Section 874.9 is revised to read as follows:


Sec. 874.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and reasonably foreseeable characteristics of 
commercially distributed devices within

[[Page 63245]]

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. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I or II device for which FDA has 
granted an exemption from the requirement of premarket notification 
must still submit a premarket notification to FDA before introducing or 
delivering for introduction into interstate commerce for commercial 
distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
     (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    169. Section 874.1070 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1070   Short increment sensitivity index (SISI) adapter.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9.
    170. Section 874.1100 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1100   Earphone cushion for audiometric testing.

* * * * *
    (b)  Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9.
    171. Section 874.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1500   Gustometer.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9. If the device is not labeled 
or otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.
    172. Section 874.1800 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1800   Air or water caloric stimulator.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9.
    173. Section 874.1925 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1925   Toynbee diagnostic tube.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9.
    174. Section 874.3300 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.3300   Hearing Aid.

* * * * *
    (b) Classification. (1) Class I (general controls) for the air-
conduction hearing aid. The air-conduction hearing aid is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 874.9.
    (2) Class II for the bone-conduction hearing aid.
    175. Section 874.3540 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.3540   Prosthesis modification instrument for ossicular 
replacement surgery.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9. If the device is not labeled 
or otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.
    176. Section 874.4100 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4100   Epistaxis balloon.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9.
    177. Section 874.4420 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4420   Ear, nose, and throat manual surgical instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9.
    178. Section 874.5300 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5300   Ear, nose, and throat examination and treatment unit.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9.
    179. Section 874.5550 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5550   Powered nasal irrigator.

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

[[Page 63246]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 874.9.
    180. Section 874.5840 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5840   Antistammering device.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 874.9.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    181. The authority citation for 21 CFR part 876 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    182. Section 876.9 is revised to read as follows:


Sec. 876.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
     (3) 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;
     (4) For assessing the risk of cardiovascular diseases;
     (5) For use in diabetes management;
     (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
     (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
     (9) For near patient testing (point of care).
    183. Section 876.5160 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5160   Urological clamp for males.

* * * * *
    (b) Classification. Class I (general controls). Except when 
intended for internal use or use on females, the device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 876.9.
    184. Section 876.5210 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5210   Enema kit.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9. The device is exempt from 
the current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.
    185. Section 876.5250 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.5250   Urine collector and accessories.

* * * * *
    (b) * * *
    (2) Class I (general controls) for a urine collector and 
accessories not intended to be connected to an indwelling catheter. The 
class I device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to Sec. 876.9. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations in part 820 of 
this chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to the general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.
    186. Section 876.5980 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.5980   Gastrointestinal tube and accessories.

* * * * *
    (b) * * *
    (2) Class I (general controls) for the dissolvable nasogastric feed 
tube guide for the nasogastric tube. The class I device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 876.9.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    188. Section 878.9 is revised to read as follows:


Sec. 878.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or

[[Page 63247]]

effectiveness, manufacturers of any commercially distributed class I or 
II device for which FDA has granted an exemption from the requirement 
of premarket notification must still submit a premarket notification to 
FDA before introducing or delivering for introduction into interstate 
commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
     (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
     (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
     (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
     (9) For near patient testing (point of care).
    189. Section 878.3250 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3250   External facial fracture fixation appliance.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.
    190. Section 878.3910 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3910   Noninflatable extremity splint.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9. If the device is not labeled 
or otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.
    191. Section 878.3925 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3925   Plastic surgery kit and accessories.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.
    192. Section 878.4040 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4040   Surgical apparel.

* * * * *
    (b)  Classification. (1) Class II (special controls) for surgical 
gowns and surgical masks.
    (2) Class I (general controls) for surgical apparel other than 
surgical gowns and surgical masks. The class I device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 878.9.
    193. Section 878.4100 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4100   Organ bag.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.
    194. Section 878.4200 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4200   Introduction/drainage catheter and accessories.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.
    195. Section 878.4320 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4320   Removable skin clip.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.
    196. Section 878.4680 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4680   Nonpowered, single patient, portable suction apparatus.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.
    197. Section 878.4760 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4760   Removable skin staple.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.
    198. Section 878.4820 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4820   Surgical instrument motors and accessories/attachments.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.
    199. Section 878.4960 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4960   Operating tables and accessories and operating chairs 
and accessories.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 878.9.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    200. The authority citation for 21 CFR part 880 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    201. Section 880.9 is revised to read as follows:

[[Page 63248]]

Sec. 880.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
    (4) For assessing the risk of cardiovascular diseases;
     (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
     (9) For near patient testing (point of care).
    202. Section 880.5090 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5090   Liquid bandage.

* * * * *
    (b) Classification. Class I (general controls). When used only as a 
skin protectant, the device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to 
Sec. 880.9.
    203. Section 880.5270 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5270   Neonatal eye 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 subject to Sec. 880.9. If the device is not labeled 
or otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.
    204. Section 880.5420 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5420   Pressure infusor for an I.V. bag.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

PART 882--NEUROLOGICAL DEVICES

    205. The authority citation for 21 CFR part 882 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    206. Section 882.9 is revised to read as follows:


Sec. 882.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;

[[Page 63249]]

     (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    207. Section 882.1200 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1200   Two-point discriminator.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 882.9. The device is also exempt 
from the current good manufacturing practice regulations in part 820 of 
this chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.
    208. Section 882.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1500   Esthesiometer.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 882.9. The device is also exempt 
from the current good manufacturing practice regulations in part 820 of 
this chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.
    209. Section 882.1750 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1750   Pinwheel.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 882.9.
    210. Section 882.4060 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4060   Ventricular cannula.

* * * * *
    (b) Classification. Class I (general controls). When made only of 
surgical grade stainless steel, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 882.9.
    211. Section 882.4545 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4545   Shunt system implantation instrument.

* * * * *
    (b) Classification. Class I (general controls). When made only of 
surgical grade stainless steel, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 882.9.
    212. Section 882.4650 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4650   Neurosurgical suture needle.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 882.9.
    213. Section 882.4750 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4750   Skull punch.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 882.9. This exemption does not 
apply to powered compound cranial drills, burrs, trephines, and their 
accessories classified under Sec. 882.4305.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    214. The authority citation for 21 CFR part 884 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    215. Section 884.9 is revised to read as follows:


Sec. 884.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
     (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
     (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    216. Section 884.1040 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.1040   Viscometer for cervical mucus.

* * * * *

[[Page 63250]]

    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 884.9.

PART 886--OPHTHALMIC DEVICES

    217. The authority citation for 21 CFR part 886 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    218. Section 886.9 is revised to read as follows:


Sec. 886.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    219. Section 886.1780 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1780   Retinoscope.

* * * * *
    (b) Classification. (1) Class II (special controls) for the AC-
powered device.
    (2) Class I (general controls) for the battery-powered device. The 
class I battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 886.9. The battery-powered device is exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.
    220. Section 886.1940 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1940   Tonometer sterilizer.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 886.9.
    221. Section 886.4070 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4070   Powered corneal burr.

* * * * *
    (b) Classification. Class I (general controls). When intended only 
for rust ring removal, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 886.9.
    222. Section 886.4300 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4300   Intraocular lens guide.

* * * * *
    (b) Classification. Class I (general controls). Except when used as 
folders or injectors for soft or foldable intraocular lenses, the 
device is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to Sec. 886.9.
    223. Section 886.4750 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4750   Ophthalmic eye shield.

* * * * *
    (b) Classification. Class I (general controls). When made only of 
plastic or aluminum, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 886.9. When made only of plastic or aluminum, the 
devices are exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180 of this chapter, with respect to general requirements 
concerning records, and Sec. 820.198 of this chapter, with respect to 
complaint files.
    224. Section 886.5850 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5850   Sunglasses (nonprescription).

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 886.9.

PART 888--ORTHOPEDIC DEVICES

    225. The authority citation for 21 CFR part 888 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    226. Section 888.9 is revised to read as follows:


Sec. 888.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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

[[Page 63251]]

device would not be associated with high morbidity or mortality. 
Because FDA cannot anticipate every change in intended use or 
characteristic that could significantly affect a device's safety or 
effectiveness, manufacturers of any commercially distributed class I or 
II device for which FDA has granted an exemption from the requirement 
of premarket notification must still submit a premarket notification to 
FDA before introducing or delivering for introduction into interstate 
commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
     (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
     (3) 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;
     (4) For assessing the risk of cardiovascular diseases;
     (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
     (7) 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;
     (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
     (9) For near patient testing (point of care).

PART 890--PHYSICAL MEDICINE DEVICES

    227. The authority citation for 21 CFR part 890 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    228. Section 890.9 is revised to read as follows:


Sec. 890.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
    (4) For assessing the risk of cardiovascular diseases;
     (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    229. Section 890.1175 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1175   Electrode cable.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 890.9. The devices are exempt from the current 
good manufacturing practice regulations in part 820 of this chapter, 
with the exception of Sec. 820.180 of this chapter, with respect to 
general requirements concerning records, and Sec. 820.198 of this 
chapter, with respect to complaint files.
    230. Section 890.5180 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5180   Manual patient rotation bed.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    231. Section 890.5710 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5710   Hot or cold disposable pack.

* * * * *
    (b) Classification. Class I (general controls). Except when 
intended for use on infants, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 890.9.

[[Page 63252]]

PART 892--RADIOLOGY DEVICES

    232. The authority citation for 21 CFR part 892 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    233. Section 892.9 is revised to read as follows:


Sec. 892.9   Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 
510(k) of the act) for a generic type of class I or II device is based 
upon the existing and 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. Because FDA cannot anticipate every change in intended 
use or characteristic that could significantly affect a device's safety 
or effectiveness, manufacturers of any commercially distributed class I 
or II device for which FDA has granted an exemption from the 
requirement of premarket notification must still submit a premarket 
notification to FDA before introducing or delivering for introduction 
into interstate commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; 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 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
     (2) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (3) 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;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
     (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) 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;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).
    234. Section 892.1300 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1300   Nuclear rectilinear scanner.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    235. Section 892.1320 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1320   Nuclear uptake probe.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    236. Section 892.1330 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1330   Nuclear whole body scanner.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    237. Section 892.1350 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1350   Nuclear scanning bed.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    238. Section 892.1410 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1410   Nuclear electrocardiograph synchronizer.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    239. Section 892.1890 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1890   Radiographic film illuminator.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    240. Section 892.1910 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1910   Radiographic grid.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    241. Section 892.1960 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1960   Radiographic intensifying screen.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    242. Section 892.1970 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1970   Radiographic ECG/respirator synchronizer.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    243. Section 892.2010 is amended by revising paragraph (b) to read 
as follows:


Sec.  892.2010   Medical image storage device.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    244. Section 892.2020 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.2020   Medical image communications device.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    245. Section 892.5650 is amended by revising paragraph (b) to read 
as follows:

[[Page 63253]]

Sec. 892.5650   Manual radionuclide applicator system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.
    246. Section 892.6500 is amended by revising paragraph (b) to read 
as follows:


Sec.  892.6500   Personnel protective shield.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.

    Dated: October 14, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-29855 Filed 11-10-98; 8:45 am]
BILLING CODE 4160-01-F