Federal Register, Volume 63 Issue 218 (Thursday, November 12, 1998)

[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 system^{2
864.9195 Blood mixing devices and blood weighing devices^{2
866.2390 Transport culture medium
866.2560 Microbial growth monitor^{3
866.2850 Automated zone reader
866.2900 Microbiological specimen collection and transport device
866.3110 Campylobacter fetus serological reagents
866.3120 Chlamydia serological reagents
866.3235 Epstein-Barr virus serological reagents
866.3370 Mycobacterium tuberculosis immunofluorescent reagents
866.3870 Trypanosoma spp. serological reagents
870.4200 Cardiopulmonary bypass accessory equipment
872.3700 Dental mercury
872.4200 Dental handpiece and accessories
872.6250 Dental chair and accessories^{4
872.6640 Dental operative unit and accessories^{5
872.6710 Boiling water sterilizer
876.5160 Urological clamps for males^{6
878.4460 Surgeon's glove
880.5090 Liquid bandage^{7
880.5680 Pediatric position holder
880.6250 Patient examination glove
880.6375 Patient lubricant
880.6760 Protective restraint
882.1030 Ataxiagraph
882.1420 Electroencephalogram (EEG) signal spectrum analyzer
882.4060 Ventricular cannula^{8
882.4545 Shunt system implantation instrument^{9
884.2980(a) Telethermographic system^{10
884.2982(a) Liquid crystal thermographic system^{11
884.5435 Unscented menstrual pads (intralabial pads and reusable
menstrual pads)
886.4070 Powered corneal burr^{12
886.4300 Intraocular lens guide^{13
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 pack^{14
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 system^{2
864.9185 Blood grouping view box
864.9195 Blood mixing devices and blood weighing devices^{2
864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic
use
864.9275 Blood bank centrifuge for in vitro diagnostic use
864.9320 Copper sulphate solution for specific gravity 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 system^{3
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 system^{4
866.5765 Retinol-binding protein immunological test system
866.5890 Inter-alpha trypsin inhibitor immunological test system
868.1910 Esophageal stethoscope
868.5620 Breathing mouthpiece
868.5640 Medicinal nonventilatory nebulizer (atomizer)
868.5675 Rebreathing device
868.5700 Nonpowered oxygen tent
868.6810 Tracheobronchial suction catheter
872.3275(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 pad^{5
872.6300 Rubber dam^{6
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 aid^{6
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 males^{7
876.5210 Enema kit
876.5250(b)(2) Urine collector and accessories^{8
876.5980(b)(2) Gastrointestinal tube and accessories^{9
878.3250 External facial fracture fixation appliance
878.3910 Noninflatable extremity splint
878.3925 Plastic surgery kit and accessories
878.4040 Surgical apparel^{10
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 bandage^{11
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 cannula^{12
882.4545 Shunt system implantation instrument^{13
882.4650 Neurosurgical suture needle
882.4750 Skull punch^{14
884.1040 Viscometer for cervical mucus
886.1780 Retinoscope^{15
886.1940 Tonometer sterilizer
886.4070 Powered corneal burr^{16
886.4300 Intraocular lens guide^{17
886.5850 Sunglasses (nonprescription
890.5180 Manual patient rotation bed
890.5710 Hot or cold disposable pack^{18
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.

Sec. 862.1040 Aldolase test system.

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.

Sec. 862.1080 Androsterone test system.

Sec. 862.1095 Ascorbic acid test system.

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

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.

Sec. 862.1165 Catecholamines (total) test system.

Sec. 862.1175 Cholesterol (total) test system.

Sec. 862.1180 Chymotrypsin test system.

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

Sec. 862.1195 Corticoids test system.

Sec. 862.1200 Corticosterone test system.

Sec. 862.1240 Cystine test system.

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

Sec. 862.1250 Desoxycorticosterone test system.

Sec. 862.1260 Estradiol test system.

Sec. 862.1265 Estriol test system.

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

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

Sec. 862.1280 Estrone test system.

Sec. 862.1285 Etiocholanolone test system.

Sec. 862.1300 Follicle-stimulating hormone test system.

Sec. 862.1325 Gastrin test system.

Sec. 862.1330 Globulin test system.

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.

Sec. 862.1370 Human growth hormone test system.

Sec. 862.1375 Histidine test system.

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

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

Sec. 862.1395 17-Hydroxyprogesterone test system.

Sec. 862.1400 Hydroxyproline test system.

Sec. 862.1405 Immunoreactive insulin test system.

Sec. 862.1430 17-Ketosteroids test system.

Sec. 862.1435 Ketones (nonquantitative) test system.

Sec. 862.1450 Lactic acid test system.

Sec. 862.1460 Leucine aminopeptidase test system.

Sec. 862.1465 Lipase test system.

Sec. 862.1475 Lipoprotein test system.

Sec. 862.1485 Luteinizing hormone test system.

Sec. 862.1500 Malic dehydrogenase test system.

Sec. 862.1505 Mucopolysaccharides (nonquantitative) test system.

Sec. 862.1510 Nitrite (nonquantitative) test system.

Sec. 862.1520 5'-Nucleotidase test system.

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.

Sec. 862.1540 Osmolality test system.

Sec. 862.1542 Oxalate test system.

Sec. 862.1550 Urinary pH (nonquantitative) test system.

Sec. 862.1560 Urinary phenylketones (nonquantitative) test system.

Sec. 862.1570 Phosphohexose isomerase test system.

Sec. 862.1590 Porphobilinogen test system.

Sec. 862.1595 Porphyrins test system.

Sec. 862.1605 Pregnanediol test system.

Sec. 862.1610 Pregnanetriol test system.

Sec. 862.1615 Pregnenolone test system.

Sec. 862.1620 Progesterone test system.

Sec. 862.1625 Prolactin (lactogen) test system.

Sec. 862.1630 Protein (fractionation) test system.

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

Sec. 862.1650 Pyruvate kinase test system.

Sec. 862.1655 Pyruvic acid test system.

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.

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.

Sec. 862.1785 Urinary urobilinogen (nonquantitative) test system.

Sec. 862.1790 Uroporphyrin test system.

Sec. 862.1795 Vanilmandelic acid test system.

Sec. 862.1805 Vitamin A test system.

Sec. 862.1820 Xylose test system.

Sec. 862.2140 Centrifugal chemistry analyzer for clinical use.

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

Sec. 862.2160 Discrete photometric chemistry analyzer for clinical
use.

Sec. 862.2170 Micro chemistry analyzer for clinical use.

Sec. 862.2250 Gas liquid chromatography system for clinical use.

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

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.

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

Sec. 862.2500 Enzyme analyzer for clinical use.

Sec. 862.2540 Flame emission photometer for clinical use.

Sec. 862.2560 Fluorometer for clinical use.

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.

Sec. 862.2730 Osmometer for clinical use.

Sec. 862.2750 Pipetting and diluting system for clinical use.

Sec. 862.2850 Atomic absorption spectrophotometer for clinical use.

Sec. 862.2860 Mass spectrometer for clinical use.

Sec. 862.2900 Automated urinalysis system.

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.

Sec. 866.3140 Corynebacterium spp. serological reagents.

Sec. 866.3145 Coxsackievirus serological reagents.

Sec. 866.3200 Echinococcus spp. serological reagents.

Sec. 866.3240 Equine encephalomyelitis virus serological reagents.

Sec. 866.3355 Listeria spp. serological reagents.

Sec. 866.3360 Lymphocytic choriomeningitis virus serological
reagents.

Sec. 866.3375 Mycoplasma spp. serological reagents.

Sec. 866.3380 Mumps virus serological reagents.

Sec. 866.3405 Poliovirus serological reagents.

Sec. 866.3480 Respiratory syncytial virus serological reagents.

Sec. 866.3500 Rickettsia serological reagents.

Sec. 866.3600 Schistosoma spp. serological reagents.

Sec. 866.3680 Sporothrix schenckii serological reagents.

Sec. 866.3740 Streptococcus spp. serological reagents.

Sec. 866.3850 Trichinella spiralis serological reagents.

Sec. 866.5060 Prealbumin immunological test system.

Sec. 866.5065 Human allotypic marker immunological test system.

Sec. 866.5160 Beta-globulin immunological test system.

[[Page 63242]]

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

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.

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

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

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

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

Sec. 866.5560 Lactic dehydrogenase immunological test system.

Sec. 866.5570 Lactoferrin immunological test system.

Sec. 866.5590 Lipoprotein X immunological test system.

Sec. 866.5715 Plasminogen immunological test system.

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.

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).

[[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.

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).

[[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.

Sec. 874.1100 Earphone cushion for audiometric testing.

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.

Sec. 874.1925 Toynbee diagnostic tube.

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.

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

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

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).

[[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.

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.

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.

Sec. 878.4200 Introduction/drainage catheter and accessories.

Sec. 878.4320 Removable skin clip.

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

Sec. 878.4760 Removable skin staple.

Sec. 878.4820 Surgical instrument motors and accessories/attachments.

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).

[[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.

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.

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).

[[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}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}