[Federal Register Volume 66, Number 143 (Wednesday, July 25, 2001)]
[Rules and Regulations]
[Pages 38786-38819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17867]



[[Page 38785]]

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Part II





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Parts 862 et al.



Medical Devices; Exemption From Premarket Notification Requirements; 
Class I Devices; Technical Amendment; Final Rule

  Federal Register / Vol. 66, No. 143 / Wednesday, July 25, 2001 / 
Rules and Regulations  

[[Page 38786]]


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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. 01N-0073]


Medical Devices; Exemption From Premarket Notification 
Requirements; Class I Devices; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
language in its medical device classification regulations for class I 
devices for consistency, to include in sections where it was not 
present, a specific reference to the limitations on exemptions from 
premarket notification requirements for each generic device classified. 
The specific reference language was included when some class I generic 
devices were first exempted under provisions of the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). These amendments will 
provide the same reference for devices that were exempted before that 
time. The language is intended to conveniently provide the reference, 
and make the sections clear and easy to read. The status of the devices 
is not being changed.

DATES: This rule is effective July 25, 2001.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 513 of the act (21 U.S.C. 360c), FDA must classify 
devices into one of three regulatory classes: Class I, class II, or 
class III. FDA classification of a device is determined by the amount 
of regulation necessary to provide a reasonable assurance of safety and 
effectiveness. Under the 1976 amendments (Public Law 94-295), as 
amended by the SMDA (Public Law 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 in 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 (Public 
Law 105-115). Section 206 of FDAMA, in part, added a new section 510(l) 
to the act. New section 510(l) of the act became effective February 19, 
1998. It 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 that is of substantial importance in 
preventing impairment of human health or it presents a potential 
unreasonable risk of illness or injury.
    To implement this provision, FDA evaluated all class I devices to 
determine which device types should become exempt under new provision 
510(l) of the act and which device types should remain subject to the 
requirements of 510(k) of the act. FDA then amended its classification 
regulations, in part, by publishing in the Federal Register of February 
2, 1998 (63 FR 5387), a list of certain class I devices that would 
become exempt from 510(k) requirements on February 19, 1998, subject, 
however to the limitations found in each classification regulation 
section (e.g., 21 CFR 862.9, 864.9, etc.), 63 FR 5387, February 2, 
1998. The limitations language of each classification states that if a 
class I or II devices is intended for a use different from that of a 
legally marketed device in that generic type, or if the modified device 
operates using a different fundamental scientific technology than that 
of a legally marketed device in that generic type, a new 510(k) 
submission and clearance is required. The limitations language also 
lists specific intended uses for in vitro diagnostics devices that 
would preclude an exemption from the requirements of 510(k). FDA issued 
a proposed rule in the Federal Register of November 12, 1998 (63 FR 
63222), to designate class I devices that are exempt from the premarket 
notification requirements, subject to certain limitations, and to 
designate class I devices that remain subject to premarket notification 
requirements under the new statutory criteria. The designations of 
these devices were codified by a final rule in the Federal Register of 
January 14, 2000 (65 FR 2296).
    As published in the January 14, 2000, Federal Register, the 
amendments state, in part, that the limitations in each classification 
regulation apply to the premarket notification exemptions for each 
generic device classified in each section. In addition to mentioning 
the limitations generally in each classification regulation, FDA noted 
in the Federal Register of January 14, 2000, publication that, for 
clarity and convenience, the classification section for each generic 
device newly exempted under section 510(l) of the act specifically 
states that the exemptions are subject to limitations. The agency 
further noted that for individual device classification sections that 
had been codified previously as exempt from premarket notification 
requirements, it would add the same subject-to-limitations language in 
the future. These amendments now add that language. For example, with 
this regulation, 21 CFR 862.1190 states that the copper test system 
``is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to the limitations in Sec. 862.9.'' 
(Emphasis added.) FDA is adding this specific reference to the 
limitations for

[[Page 38787]]

consistency, clarity, and convenience. The status of the devices is not 
changing.
    This document is published as a final rule with the effective date 
shown under the DATES section above. FDA has already established by 
regulation that exemptions from premarket notification are subject to 
certain limitations (e.g., 21 CFR 862.9). This rule merely cross-
references, for clarity and convenience, in individual classification 
regulations the sections that establish these limitations. FDA, 
therefore, has determined that this final rule has no substantive 
impact on the public. FDA, therefore, for good cause, finds under 5 
U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are 
unnecessary and that this rule may take effect upon publication.

II. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

    FDA has examined the impact of the rule under Executive Order 12866 
and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by 
subtitle D of the Small Business Regulatory Fairness Act of 1996 
(Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 
(Public Law 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 final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
order. In addition, this rule is not a significant regulatory action as 
defined by the Executive order and so is not subject to review under 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule does not change the status quo for 
these devices, the agency certifies that this final rule will not have 
a significant economic impact on a substantial number of small 
entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 
requires that agencies prepare a written statement of anticipated costs 
and benefits before proposing any rule that may result in an 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100 million in any one year (adjusted 
annually for inflation). The Unfunded Mandates Reform Act does not 
require FDA to prepare a statement of costs and benefits for the final 
rule, because the final rule is not expected to result in any 1-year 
expenditure that would exceed $100 million.

IV. Paperwork Reduction Act of 1995

    This final 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.

List of Subjects

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

    Medical devices.

21 CFR Part 864

    Biologics, Blood, Laboratories, Medical devices, Packaging and 
containers.

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, 21 CFR parts 
862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 
890, and 892 are amended 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 862.1190 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1190  Copper 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 the limitations in Sec. 862.9.
    3. Section 862.1210 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1210  Creatine 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 the limitations in Sec. 862.9.
    4. Section 862.1255 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1255  2,3-Diphosphoglyceric acid test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.
    5. Section 862.1290 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1290  Fatty acids 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 the limitations in Sec. 862.9.
    6. Section 862.1305 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1305  Formiminoglutamic acid (FIGLU) 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 the limitations in Sec. 862.9.
    7. Section 862.1320 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1320  Gastric acidity 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 the limitations in Sec. 862.9.
    8. Section 862.1365 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1365  Glutathione 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 the limitations in Sec. 862.9
    9. Section 862.1380 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1380  Hydroxybutyric dehydrogenase test system.

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

[[Page 38788]]

    10. Section 862.1420 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1420  Isocitric dehydrogenase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.
    11. Section 862.1470 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1470  Lipid (total) test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.
    12. Section 862.1490 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1490  Lysozyme (muramidase) 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 the limitations in Sec. 862.9.
    13. Section 862.1515 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1515  Nitrogen (amino-nitrogen) 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 the limitations in Sec. 862.9.
    14. Section 862.1565 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1565  6-Phosphogluconate dehydrogenase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.
    15. Section 862.1575 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1575  Phospholipid 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 the limitations in Sec. 862.9.
    16. Section 862.1640 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1640  Protein-bound iodine 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 the limitations in Sec. 862.9.
    17. Section 862.1670 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1670  Sorbitol dehydrogenase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.
    18. Section 862.1720 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1720  Triose phosphate isomerase test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 subject to the limitations in Sec. 862.9.
    19. Section 862.1815 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.1815  Vitamin E test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 subject to the limitations in Sec. 862.9.
    20. Section 862.2050 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2050  General purpose laboratory equipment labeled or promoted 
for a specific medical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
identified in paragraph (a) of this section and is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 862.9. 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, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    21. Section 862.2100 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2100  Calculator/data processing module 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 the limitations in Sec. 862.9.
    22. Section 862.2230 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2230  Chromatographic separation material for clinical use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.
    23. Section 862.2310 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2310  Clinical sample concentrator.

* * * * *
    (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 the limitations in Sec. 862.9.
    24. Section 862.2320 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2320  Beta or gamma counter 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 the limitations in Sec. 862.9.
    25. Section 862.2485 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2485  Electrophoresis apparatus 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 the limitations in Sec. 862.9.
    26. Section 862.2720 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2720  Plasma oncometer 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 the limitations in Sec. 862.9.
    27. Section 862.2800 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2800  Refractometer 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 the limitations in Sec. 862.9.
    28. Section 862.2920 is amended by revising paragraph (b) to read 
as follows:


Sec. 862.2920  Plasma viscometer for clinical use.

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

[[Page 38789]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    30. Section 864.1850 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.1850  Dye and chemical solution stains.

* * * * *
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. These 
devices are also exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    31. Section 864.2220 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2220  Synthetic cell and tissue culture media and components.

* * * * *
    (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 the limitations in Sec. 864.9.
    32. Section 864.2240 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2240  Cell and tissue culture supplies and equipment.

* * * * *
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. If the 
devices are not labeled or otherwise represented as sterile, they are 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    33. Section 864.2260 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2260  Chromosome culture 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 the limitations in Sec. 864.9.
    34. Section 864.2360 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2360  Mycoplasma detection media and components.

* * * * *
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    35. Section 864.2800 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2800  Animal and human sera.

* * * * *
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    36. Section 864.2875 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.2875  Balanced salt solutions or formulations.

* * * * *
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    37. Section 864.3010 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.3010  Tissue processing equipment.

* * * * *
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. The 
devices are also exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    38. Section 864.3300 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.3300  Cytocentrifuge.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    39. Section 864.3400 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.3400  Device for sealing microsections.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    40. Section 864.3600 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.3600  Microscopes and accessories.

* * * * *
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    41. Section 864.3800 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.3800  Automated slide stainer.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    42. Section 864.3875 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.3875  Automated tissue processor.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    43. Section 864.4010 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.4010  General purpose reagent.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    44. Section 864.4400 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.4400  Enzyme preparations.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    45. Section 864.5350 is amended by revising paragraph (b) to read 
as follows:

[[Page 38790]]

Sec. 864.5350  Microsedimentation centrifuge.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    46. Section 864.5800 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.5800  Automated sedimentation rate device.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    47. Section 864.5850 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.5850  Automated slide spinner.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    48. Section 864.6160 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.6160  Manual blood cell counting device.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    49. Section 864.6600 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.6600  Osmotic fragility test.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    50. Section 864.6700 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.6700  Erythrocyte sedimentation rate test.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    51. Section 864.7660 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.7660  Leukocyte alkaline phosphatase test.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    52. Section 864.7675 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.7675  Leukocyte peroxidase test.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    53. Section 864.7900 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.7900  Thromboplastin generation test.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    54. Section 864.8200 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.8200  Blood cell diluent.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    55. Section 864.8500 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.8500  Lymphocyte separation medium.

* * * * *
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.
    56. Section 864.8540 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.8540  Red cell lysing reagent.

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

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    58. Section 866.2050 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2050  Staphylococcal typing bacteriophage.

* * * * *
    (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 the limitations in Sec. 866.9.
    59. Section 866.2120 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2120  Anaerobic chamber.

* * * * *
    (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 the limitations in Sec. 866.9. The 
device is also exempt from the good manufacturing practice regulations 
in part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    60. Section 866.2160 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2160  Coagulase plasma.

* * * * *
    (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 the limitations in Sec. 866.9.
    61. Section 866.2170 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2170  Automated colony counter.

* * * * *
    (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 the limitations in Sec. 866.9.
    62. Section 866.2180 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2180  Manual colony counter.

* * * * *
    (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 the limitations in Sec. 866.9. The 
device is also exempt from the good manufacturing practice regulations 
in part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    63. Section 866.2300 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2300  Multipurpose culture medium.

* * * * *
    (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 the limitations in Sec. 866.9.
    64. Section 866.2320 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2320  Differential culture medium.

* * * * *

[[Page 38791]]

    (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 the limitations in Sec. 866.9.
    65. Section 866.2330 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2330  Enriched culture medium.

* * * * *
    (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 the limitations in Sec. 866.9.
    66. Section 866.2350 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2350  Microbiological assay culture medium.

* * * * *
    (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 the limitations in Sec. 866.9.
    67. Section 866.2360 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2360  Selective culture medium.

* * * * *
    (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 the limitations in Sec. 866.9.
    68. Section 866.2440 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2440  Automated medium dispensing and stacking 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 the limitations in Sec. 866.9. The 
device is also exempt from the good manufacturing practice regulations 
in part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    69. Section 866.2450 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2450  Supplement for culture media.

* * * * *
    (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 the limitations in Sec. 866.9.
    70. Section 866.2480 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2480  Quality control kit for culture media.

* * * * *
    (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 the limitations in Sec. 866.9.
    71. Section 866.2500 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2500  Microtiter diluting and dispensing 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 the limitations in Sec. 866.9.
    72. Section 866.2540 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2540  Microbiological incubator.

* * * * *
    (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 the limitations in Sec. 866.9. The 
device is also exempt from the good manufacturing practice regulations 
in part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    73. Section 866.2580 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2580  Gas-generating 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 the limitations in Sec. 866.9.
    74. Section 866.2600 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.2600  Wood's fluorescent lamp.

* * * * *
    (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 the limitations in Sec. 866.9. The 
device is also exempt from the good manufacturing practice regulations 
in part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    75. Section 866.3010 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3010  Acinetobacter calcoaceticus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    76. Section 866.3020 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3020  Adenovirus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    77. Section 866.3035 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3035  Arizona spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    78. Section 866.3065 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3065  Bordetella spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    79. Section 866.3125 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3125  Citrobacter spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    80. Section 866.3205 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3205  Echovirus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    81. Section 866.3250 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3250  Erysipelothrix rhusiopathiae serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    82. Section 866.3255 is amended by revising paragraph (b) to read 
as follows:

[[Page 38792]]

Sec. 866.3255  Escherichia coli serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    83. Section 866.3270 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3270  Flavobacterium spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    84. Section 866.3330 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3330  Influenza virus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    85. Section 866.3340 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3340  Klebsiella spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    86. Section 866.3400 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3400  Parainfluenza virus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    87. Section 866.3410 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3410  Proteus spp. (Weil-Felix) serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    88. Section 866.3470 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3470  Reovirus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    89. Section 866.3490 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3490  Rhinovirus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    90. Section 866.3520 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3520  Rubeola (measles) virus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    91. Section 866.3630 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3630  Serratia spp. serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    92. Section 866.3700 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3700  Staphylococcus aureus serological reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    93. Section 866.3720 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3720  Streptococcus spp. exoenzyme reagents.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    94. Section 866.4100 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.4100  Complement reagent.

* * * * *
    (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 the limitations in Sec. 866.9.
    95. Section 866.4500 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.4500  Immunoelectrophoresis equipment.

* * * * *
    (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 the limitations in Sec. 866.9.
    96. Section 866.4520 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.4520  Immunofluorometer equipment.

* * * * *
    (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 the limitations in Sec. 866.9.
    97. Section 866.4540 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.4540  Immunonephelometer equipment.

* * * * *
    (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 the limitations in Sec. 866.9.
    98. Section 866.4600 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.4600  Ouchterlony agar plate.

* * * * *
    (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 the limitations in Sec. 866.9.
    99. Section 866.4800 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.4800  Radial immunodiffusion plate.

* * * * *
    (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 the limitations in Sec. 866.9.
    100. Section 866.4830 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.4830  Rocket immunoelectrophoresis equipment.

* * * * *
    (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 the limitations in Sec. 866.9.
    101. Section 866.4900 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.4900  Support gel.

* * * * *
    (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 the limitations in Sec. 866.9.

[[Page 38793]]

    102. Section 866.5170 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5170  Breast milk 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 the limitations in Sec. 866.9.
    103. Section 866.5220 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5220  Cohn fraction II 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 the limitations in Sec. 866.9.
    104. Section 866.5230 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5230  Colostrum 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 the limitations in Sec. 866.9.
    105. Section 866.5360 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5360  Cohn fraction IV 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 the limitations in Sec. 866.9.
    106. Section 866.5370 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5370  Cohn fraction V 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 the limitations in Sec. 866.9.
    107. Section 866.5520 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5520  Immunoglobulin G (Fab fragment specific) 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 the limitations in Sec. 866.9.
    108. Section 866.5530 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5530  Immunoglobulin G (Fc fragment specific) immunological 
test system.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.
    109. Section 866.5540 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5540  Immunoglobulin G (Fd fragment specific) 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 the limitations in Sec. 866.9.
    110. Section 866.5700 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5700  Whole human plasma or serum 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 the limitations in Sec. 866.9.
    111. Section 866.5800 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5800  Seminal fluid (sperm) 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 the limitations in Sec. 866.9.
    112. Section 866.5860 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5860  Total spinal fluid immunological test system.

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

PART 868--ANESTHESIOLOGY DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    114. Section 868.1030 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1030  Manual algesimeter.

* * * * *
    (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 the limitations in Sec. 868.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    115. Section 868.1100 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1100  Arterial blood sampling 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 the limitations in Sec. 868.9.
    116. Section 868.1575 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1575  Gas collection vessel.

* * * * *
    (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 the limitations in Sec. 868.9.
    117. Section 868.1870 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1870  Gas volume calibrator.

* * * * *
    (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 the limitations in Sec. 868.9.
    118. Section 868.1930 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1930  Stethoscope head.

* * * * *
    (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 the limitations in Sec. 868.9.
    119. Section 868.1965 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1965  Switching valve (ploss).

* * * * *
    (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 the limitations in Sec. 868.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    120. Section 868.1975 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.1975  Water vapor analyzer.

* * * * *

[[Page 38794]]

    (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 the limitations in Sec. 868.9.
    121. Section 868.2300 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2300  Bourdon gauge flowmeter.

* * * * *
    (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 the limitations in Sec. 868.9.
    122. Section 868.2320 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2320  Uncompensated thorpe tube flowmeter.

* * * * *
    (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 the limitations in Sec. 868.9.
    123. Section 868.2340 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2340  Compensated thorpe tube flowmeter.

* * * * *
    (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 the limitations in Sec. 868.9.
    124. Section 868.2350 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2350  Gas calibration flowmeter.

* * * * *
    (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 the limitations in Sec. 868.9.
    125. Section 868.2610 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2610  Gas pressure gauge.

* * * * *
    (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 the limitations in Sec. 868.9.
    126. Section 868.2620 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2620  Gas pressure calibrator.

* * * * *
    (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 the limitations in Sec. 868.9.
    127. Section 868.2700 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2700  Pressure regulator.

* * * * *
    (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 the limitations in Sec. 868.9.
    128. Section 868.2875 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2875  Differential pressure transducer.

* * * * *
    (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 the limitations in Sec. 868.9.
    129. Section 868.2885 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.2885  Gas flow transducer.

* * * * *
    (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 the limitations in Sec. 868.9.
    130. Section 868. 5100 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5100  Nasopharyngeal airway.

* * * * *
    (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 the limitations in Sec. 868.9.
    131. Section 868.5110 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5110  Oropharyngeal airway.

* * * * *
    (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 the limitations in Sec. 868.9.
    132. Section 868.5220 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5220  Blow bottle.

* * * * *
    (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 the limitations in Sec. 868.9. 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    133. Section 868.5240 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5240  Anesthesia breathing circuit.

* * * * *
    (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 the limitations in Sec. 868.9.
    134. Section 868.5280 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5280  Breathing tube support.

* * * * *
    (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 the limitations in Sec. 868.9.
    135. Section 868.5300 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5300  Carbon dioxide absorbent.

* * * * *
    (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 the limitations in Sec. 868.9.
    136. Section 868.5310 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5310  Carbon dioxide absorber.

* * * * *
    (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 the limitations in Sec. 868.9.
    137. Section 868.5320 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5320  Reservoir 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 the limitations in Sec. 868.9.
    138. Section 868.5340 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5340  Nasal oxygen cannula.

* * * * *
    (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 the limitations in Sec. 868.9.
    139. Section 868.5350 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5350  Nasal oxygen 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 the limitations in Sec. 868.9.
    140. Section 868.5365 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5365  Posture chair for cardiac or pulmonary treatment.

* * * * *

[[Page 38795]]

    (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 the limitations in Sec. 868.9.
    141. Section 868.5375 is amended by revising paragraph (b) to read 
as follows:


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

* * * * *
    (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 the limitations in Sec. 868.9.
    142. Section 868.5420 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5420  Ether hook.

* * * * *
    (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 the limitations in Sec. 868.9. 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    143. Section 868.5460 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5460  Therapeutic humidifier for home use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 868.9.
    144. Section 868.5530 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5530  Flexible laryngoscope.

* * * * *
    (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 the limitations in Sec. 868.9.
    145. Section 868.5540 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5540  Rigid laryngoscope.

* * * * *
    (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 the limitations in Sec. 868.9
    146. Section 868.5550 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5550  Anesthetic gas mask.

* * * * *
    (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 the limitations in Sec. 868.9.
    147. Section 868.5560 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5560  Gas mask head strap.

* * * * *
    (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 the limitations in Sec. 868.9.
    148. Section 868.5570 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5570  Nonrebreathing mask.

* * * * *
    (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 the limitations in Sec. 868.9.
    149. Section 868.5580 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5580  Oxygen mask.

* * * * *
    (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 the limitations in Sec. 868.9.
    150. Section 868.5590 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5590  Scavenging mask.

* * * * *
    (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 the limitations in Sec. 868.9.
    151. Section 868.5600 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5600  Venturi mask.

* * * * *
    (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 the limitations in Sec. 868.9.
    152. Section 868.5760 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5760  Cuff spreader.

* * * * *
    (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 the limitations in Sec. 868.9. 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    153. Section 868.5770 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5770  Tracheal tube fixation 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 the limitations in Sec. 868.9.
    154. Section 868.5780 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5780  Tube introduction forceps.

* * * * *
    (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 the limitations in Sec. 868.9.
    155. Section 868.5790 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5790  Tracheal tube stylet.

* * * * *
    (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 the limitations in Sec. 868.9.
    156. Section 868.5795 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5795  Tracheal tube cleaning brush.

* * * * *
    (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 the limitations in Sec. 868.9. 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    157. Section 868.5810 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5810  Airway connector.

* * * * *
    (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 the limitations in Sec. 868.9.
    158. Section 868.5820 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5820  Dental protector.

* * * * *
    (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 the limitations in Sec. 868.9.

[[Page 38796]]

    159. Section 868.5860 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5860  Pressure tubing 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 the limitations in Sec. 868.9.
    160. Section 868.5975 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5975  Ventilator tubing.

* * * * *
    (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 the limitations in Sec. 868.9.
    161. Section 868.5995 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.5995  Tee drain (water trap).

* * * * *
    (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 the limitations in Sec. 868.9.
    162. Section 868.6100 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6100  Anesthetic cabinet, table, or tray.

* * * * *
    (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 the limitations in Sec. 868.9.
    163. Section 868.6175 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6175  Cardiopulmonary emergency cart.

* * * * *
    (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 the limitations in Sec. 868.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    164. Section 868.6225 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6225  Nose clip.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 868.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    165. Section 868.6400 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6400  Calibration gas.

* * * * *
    (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 the limitations in Sec. 868.9.
    166. Section 868.6700 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6700  Anesthesia stool.

* * * * *
    (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 the limitations in Sec. 868.9.
    167. Section 868.6820 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6820  Patient position support.

* * * * *
    (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 the limitations in Sec. 868.9.
    168. Section 868.6885 is amended by revising paragraph (b) to read 
as follows:


Sec. 868.6885  Medical gas yoke assembly.

* * * * *
    (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 the limitations in Sec. 868.9.

PART 870--CARDIOVASCULAR DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    170. Section 870.1875 is amended by revising paragraph (a)(2) to 
read as follows:


Sec. 870.1875  Stethoscope.

    (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 the limitations in Sec. 870.9.
* * * * *
    171. Section 870.2390 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.2390  Phonocardiograph.

* * * * *
    (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 the limitations in Sec. 870.9.
    172. Section 870.2600 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.2600  Signal isolation 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 the limitations in Sec. 870.9.
    173. Section 870.2620 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.2620  Line isolation monitor.

* * * * *
    (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 the limitations in Sec. 870.9.
    174. Section 870.2640 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.2640  Portable leakage current alarm.

* * * * *
    (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 the limitations in Sec. 870.9.
    175. Section 870.2810 is amended by revising paragraph (b) to read 
as follows.


Sec. 870.2810  Paper chart recorder.

* * * * *
    (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 the limitations in Sec. 870.9.
    176. Section 870.3650 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3650  Pacemaker polymeric mesh 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 the limitations in Sec. 870.9.
    177. Section 870.3670 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3670  Pacemaker charger.

* * * * *
    (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 the limitations in Sec. 870.9.
    178. Section 870.3690 is amended by revising paragraph (b) to read 
as follows:

[[Page 38797]]

Sec. 870.3690  Pacemaker test magnet.

* * * * *
    (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 the limitations in Sec. 870.9.
    179. Section 870.3730 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3730  Pacemaker service tools.

* * * * *
    (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 the limitations in Sec. 870.9.
    180. Section 870.3945 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.3945  Prosthetic heart valve sizer.

* * * * *
    (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 the limitations in Sec. 870.9.
    181. Section 870.4500 is amended by revising paragraph (b) to read 
as follows:


Sec. 870.4500  Cardiovascular surgical instruments.

* * * * *
    (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 the limitations in Sec. 870.9.

PART 872--DENTAL DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    183. Section 872.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1500  Gingival fluid measurer.

* * * * *
    (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 the limitations in Sec. 872.9.
    184. Section 872.1730 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1730  Electrode gel for pulp testers.

* * * * *
    (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 the limitations in Sec. 872.9.
    185. Section 872.1820 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1820  Dental x-ray exposure alignment 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 the limitations in Sec. 872.9.
    186. Section 872.1840 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1840  Dental x-ray position indicating device.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9.
    187. Section 872.1850 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1850  Lead-lined position indicator.

* * * * *
    (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 the limitations in Sec. 872.9.
    188. Section 872.1905 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.1905  Dental x-ray film holder.

* * * * *
    (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 the limitations in Sec. 872.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exceptions of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    189. Section 872.3080 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3080  Mercury and alloy dispenser.

* * * * *
    (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 the limitations in Sec. 872.9.
    190. Section 872.3100 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3100  Dental amalgamator.

* * * * *
    (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 the limitations in Sec. 872.9.
    191. Section 872. 3110 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3110  Dental amalgam capsule.

* * * * *
    (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 the limitations in Sec. 872.9.
    192. Section 872.3130 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3130  Preformed anchor.

* * * * *
    (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 the limitations in Sec. 872.9.
    193. Section 872.3140 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3140  Resin applicator.

* * * * *
    (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 the limitations in Sec. 872.9. If the 
device is not labeled or otherwise represented as sterile, the device 
is exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exceptions of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    194. Section 872.3150 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3150  Articulator.

* * * * *
    (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 the limitations in Sec. 872.9. If the 
device is not labeled or otherwise represented as sterile, the device 
is exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exceptions of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    195. Section 872.3165 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3165  Precision attachment.

* * * * *
    (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 the limitations in Sec. 872.9.
    196. Section 872.3220 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3220  Facebow.

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

[[Page 38798]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 872.9. If the device is not 
labeled or otherwise represented as sterile, the device is exempt from 
the current good manufacturing practice regulations in part 820 of this 
chapter, with the exceptions of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
    197. Section 872.3240 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3240  Dental bur.

* * * * *
    (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 the limitations in Sec. 872.9.
    198. Section 872.3285 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3285  Preformed clasp.

* * * * *
    (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 the limitations in Sec. 872.9.
    199. Section 872.3330 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3330  Preformed crown.

* * * * *
    (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 the limitations in Sec. 872.9.
    200. Section 872.3350 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3350  Gold or stainless steel cusp.

* * * * *
    (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 the limitations in Sec. 872.9.
    201. Section 872.3360 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3360  Preformed cusp.

* * * * *
    (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 the limitations in Sec. 872.9.
    202. Section 872.3410 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3410  Ethylene oxide homopolymer and/or carboxymethylcellulose 
sodium denture adhesive.

* * * * *
    (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 the limitations in Sec. 872.9.
    203. Section 872.3490 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3490  Carboxymethylcellulose sodium and/or 
polyvinylmethylether maleic acid calcium-sodium double salt denture 
adhesive.

* * * * *
    (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 the limitations in Sec. 872.9.
    204. Section 872.3520 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3520  OTC denture cleanser.

* * * * *
    (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 the limitations in Sec. 872.9.
    205. Section 872.3530 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3530  Mechanical denture cleaner.

* * * * *
    (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 the limitations in Sec. 872.9.
    206. Section 872.3580 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3580  Preformed gold denture tooth.

* * * * *
    (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 the limitations in Sec. 872.9.
    207. Section 872.3670 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3670  Resin impression tray material.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    208. Section 872.3730 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3730  Pantograph.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    209. Section 872.3740 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3740  Retentive and splinting pin.

* * * * *
    (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 the limitations in Sec. 872.9
    210. Section 872.3810 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3810  Root canal post.

* * * * *
    (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 the limitations in Sec. 872.9.
    211. Section 872.3830 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3830  Endodontic paper point.

* * * * *
    (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 the limitations in Sec. 872.9.
    212. Section 872.3840 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3840  Endodontic silver point.

* * * * *
    (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 the limitations in Sec. 872.9.
    213. Section 872.3850 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3850  Gutta percha.

* * * * *
    (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 the limitations in Sec. 872.9.
    214. Section 872.3900 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3900  Posterior artificial tooth with a metal insert.

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

[[Page 38799]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 872.9.
    215. Section 872.3910 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.3910  Backing and facing for an artificial tooth.

* * * * *
    (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 the limitations in Sec. 872.9.
    216. Section 872.4130 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4130  Intraoral dental drill.

* * * * *
    (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 the limitations in Sec. 872.9.
    217. Section 872.4565 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4565  Dental hand instrument.

* * * * *
    (b) Classification. Class I (general controls). If the device is 
made of the same materials that were used in the device before May 28, 
1976, it is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 872.9.
    218. Section 872.4620 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4620  Fiber optic dental light.

* * * * *
    (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 the limitations in Sec. 872.9.
    219. Section 872.4630 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4630  Dental operating light.

* * * * *
    (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 the limitations in Sec. 872.9.
    220. Section 872.4730 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.4730  Dental injecting needle.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9.
    221. Section 872.5410 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.5410  Orthodontic appliance 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 the limitations in Sec. 872.9.
    222. Section 872.5525 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.5525  Preformed tooth positioner.

* * * * *
    (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 the limitations in Sec. 872.9.
    223. Section 872.6010 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6010  Abrasive device 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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    224. Section 872.6030 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6030  Oral cavity abrasive polishing agent.

* * * * *
    (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 the limitations in Sec. 872.9.
    225. Section 872.6050 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6050  Saliva absorber.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    226. Section 872.6100 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6100  Anesthetic warmer.

* * * * *
    (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 the limitations in Sec. 872.9.
    227. Section 872.6140 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6140  Articulation paper.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    228. Section 872.6200 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6200  Base plate shellac.

    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    229. Section 872.6290 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6290  Prophylaxis cup.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    230. Section 872.6475 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6475  Heat source for bleaching teeth.

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

[[Page 38800]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 872.9.
    231. Section 872.6510 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6510  Oral irrigation unit.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9.
    232. Section 872.6570 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6570  Impression 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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    233. Section 872.6650 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6650  Massaging pick or tip for oral hygiene.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    234. Section 872.6670 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6670  Silicate protector.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    235. Section 872.6710 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6710  Boiling water 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 the limitations in Sec. 872.9.
    236. Section 872.6855 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6855  Manual toothbrush.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    237. Section 872.6865 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6865  Powered toothbrush.

* * * * *
    (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 the limitations in Sec. 872.9.
    238. Section 872.6870 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6870  Disposable flouride tray.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    239. Section 872.6880 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6880  Preformed impression tray.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    240. Section 872.6890 is amended by revising paragraph (b) to read 
as follows:


Sec. 872.6890  Intraoral dental wax.

* * * * *
    (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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.

PART 874--EAR, NOSE, AND THROAT DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    242. Section 874.1060 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1060  Acoustic chamber for audiometric testing.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 874.9.
    243. Section 874.1080 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.1080  Audiometer calibration set.

* * * * *
    (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 the limitations in Sec. 874.9.
    244. Section 874.3375 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.3375  Battery-powered artificial larynx.

* * * * *
    (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 the limitations in Sec. 874.9.
    245. Section 874.4140 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4140  Ear, nose, and throat bur.

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

[[Page 38801]]

    246. Section 874.4175 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4175  Nasopharyngeal 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 the limitations in Sec. 874.9.
    247. Section 874.4350 is amended by revising paragraph (b) to read 
as follows:


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

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 874.9.
    248. Section 874.4750 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4750  Laryngostroboscope.

* * * * *
    (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 the limitations in Sec. 874.9.
    249. Section 874.4770 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.4770  Otoscope.

* * * * *
    (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 the limitations in Sec. 874.9 only when 
used in the external ear canal.
    250. Section 874.5220 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5220  Ear, nose, and throat drug administration 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 the limitations in 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, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.
    251. Section 874.5800 is amended by revising paragraph (b) to read 
as follows:


Sec. 874.5800  External nasal 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 the limitations in Sec. 874.9.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    252. 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.
    253. Section 876.1075 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.1075  Gastroenterology-urology biopsy instrument.

* * * * *
    (b)  *  *  *
    (2) Class I for the biopsy forceps cover and the non-electric 
biopsy forceps. The devices subject to this paragraph (b)(2) are exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.
    254. Section 876.1500 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.1500  Endoscope and accessories.

* * * * *
    (b)  *  *  *
    (2) Class I for the photographic accessories for endoscope, 
miscellaneous bulb adapter for endoscope, binocular attachment for 
endoscope, eyepiece attachment for prescription lens, teaching 
attachment, inflation bulb, measuring device for panendoscope, 
photographic equipment for physiologic function monitor, special lens 
instrument for endoscope, smoke removal tube, rechargeable battery box, 
pocket battery box, bite block for endoscope, and cleaning brush for 
endoscope. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807of this 
chapter, subject to the limitations in Sec. 876.9.
    255. Section 876.4530 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.4530  Gastroenterology-urology fiberoptic retractor.

* * * * *
    (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 the limitations in Sec. 876.9.
    256. Section 876.4560 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.4560  Ribdam.

* * * * *
    (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 the limitations in Sec. 876.9.
    257. Section 876.4590 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.4590  Interlocking urethral sound.

* * * * *
    (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 the limitations in Sec. 876.9.
    258. Section 876.4730 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.4730  Manual gastroenterology-urology surgical instrument 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 the limitations in Sec. 876.9.
    259. Section 876.4890 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.4890  Urological table and accessories.

* * * * *
    (b)  *  *  *
    (2) Class I for the manually powered table and accessories, and for 
stirrups for electrically powered table. The device subject to this 
paragraph (b)(2) is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 876.9.
    260. Section 876.5030 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5030  Continent ileostomy 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 the limitations in Sec. 876.9.
    261. Section 876.5090 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.5090  Supra` urological catheter and accessories.

* * * * *
    (b)  *  *  *
    (2) Class I for the catheter punch instrument, nondisposable 
cannula and trocar, and gastro-urological trocar. The devices subject 
to this paragraph (b)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 876.9.
    262. Section 876.5130 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.5130  Urological catheter and accessories.

* * * * *
    (b)  *  *  *
    (2) Class I for the ureteral stylet (guidewire), stylet for 
gastrourological

[[Page 38802]]

catheter, ureteral catheter adapter, ureteral catheter connector, and 
ureteral catheter holder. The devices subject to this paragraph (b)(2) 
are exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to the limitations in Sec. 876.9.
    263. 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, 
subject to the limitations in 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, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.
    264. Section 876.5450 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5450  Rectal dilator.

* * * * *
    (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 the limitations in Sec. 876.9.
    265. Section 876.5520 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.5520  Urethral dilator.

* * * * *
    (b)  *  *  *
    (2) Class I for the urethrometer, urological bougie, filiform and 
filiform follower, and metal or plastic urethral sound. The devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to the limitations in Sec. 876.9.
    266. Section 876.5540 is amended by revising paragraph (b)(4) to 
read as follows:


Sec. 876.5540  Blood access device and accessories.

* * * * *
    (b)  *  *  *
    (4) Class I for the cannula clamp, disconnect forceps, crimp plier, 
tube plier, crimp ring, and joint ring, accessories for both the 
implanted and nonimplanted blood access device. The devices subject to 
this paragraph (b)(4) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 876.9.
* * * * *
    267. Section 876.5820 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 876.5820  Hemodialysis system and accessories.

* * * * *
    (b)  *  *  *
    (2) Class I for other accessories of the hemodialysis system remote 
from the extracorporeal blood system and the dialysate delivery system, 
such as the unpowered dialysis chair, hemodialysis start/stop tray, 
dialyzer holder set, and dialysis tie gun and ties. The devices subject 
to this paragraph (b)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 876.9.
    268. Section 876.5900 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5900  Ostomy pouch 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 the limitations in Sec. 876.9.
    269. Section 876.5920 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5920  Protective garment for incontinence.

* * * * *
    (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 the limitations in Sec. 876.9. 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, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.
    270. Section 876.5970 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.5970  Hernia support.

* * * * *
    (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 the limitations in Sec. 876.9. 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, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    271. The authority citation for 21 CFR continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
    272. Section 878.1800 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.1800  Speculum 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 the limitations in Sec. 878.9.
    273. Section 878.3750 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3750  External prosthesis adhesive.

* * * * *
    (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 the limitations in Sec. 878.9.
    274. Section 878.3800 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3800  External aesthetic restoration prosthesis.

* * * * *
    (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 the limitations in Sec. 878.9. If the 
device is intended for use without an external prosthesis adhesive to 
fasten it to the body, the device is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.
    275. Section 878.3900 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.3900  Inflatable 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 the limitations in Sec. 878.9.
    276. Section 878.4160 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4160  Surgical camera 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 the limitations in Sec. 878.9.
    277. Section 878.4380 is amended by revising paragraph (b) to read 
as follows:

[[Page 38803]]

Sec. 878.4380  Drape adhesive.

* * * * *
    (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 the limitations in Sec. 878.9.
    278. Section 878.4440 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4440  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 the limitations in Sec. 878.9.
    279. Section 878.4450 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4450  Nonabsorbable gauze for internal use.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 878.9.
    280. Section 878.4460 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4460  Surgeon's glove.

* * * * *
    (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 the limitations in Sec. 878.9.
    281. Section 878.4470 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4470  Surgeon's gloving cream.

* * * * *
    (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 the limitations in Sec. 878.9.
    282. Section 878.4635 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4635  Ultraviolet lamp for tanning.

* * * * *
    (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 the limitations in Sec. 878.9.
    283. Section 878.4660 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4660  Skin marker.

* * * * *
    (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 the limitations in Sec. 878.9.
    284. Section 878.4700 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4700  Surgical microscope 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 the limitations in Sec. 878.9.
    285. Section 878.4730 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4730  Surgical skin degreaser or adhesive tape solvent.

* * * * *
    (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 the limitations in Sec. 878.9.
    286. Section 878.4800 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4800  Manual surgical instrument for general 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 the limitations in Sec. 878.9.
    287. Section 878.4810 is amended by revising paragraph (b)(2) to 
read as follows:


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

* * * * *
    (b)  *  *  *
    (2) Class I for special laser gas mixtures used as a lasing medium 
for this class of lasers. The devices subject to this paragraph (b)(2) 
are exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter, subject to the limitations in Sec. 878.9.
    288. Section 878.4930 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4930  Suture retention 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 the limitations in Sec. 878.9.
    289. Section 878.4950 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.4950  Manual operating table and accessories and manual 
operating chair 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 the limitations in Sec. 878.9.
    290. Section 878.5350 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.5350  Needle-type epilator.

* * * * *
    (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 the limitations in Sec. 878.9.
    291. Section 878.5900 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.5900  Nonpneumatic tourniquet.

* * * * *
    (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 the limitations in Sec. 878.9.
    292. Section 878.5910 is amended by revising paragraph (b) to read 
as follows:


Sec. 878.5910  Pneumatic tourniquet.

* * * * *
    (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 the limitations in Sec. 878.9.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    294. Section 880.2400 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.2400  Bed-patient monitor.

* * * * *
    (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 the limitations in Sec. 880.9.
    295. Section 880.2700 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.2700  Stand-on patient scale.

* * * * *
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    296. Section 880.2720 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.2720  Patient scale.

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

[[Page 38804]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 880.9.
    297. Section 880.2740 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.2740  Surgical sponge scale.

* * * * *
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    298. Section 880.2900 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.2900  Clinical color change thermometer.

* * * * *
    (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 the limitations in Sec. 880.9.
    299. Section 880.5075 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5075  Elastic bandage.

* * * * *
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    300. Section 880.5110 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5110  Hydraulic adjustable hospital 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 the limitations in Sec. 880.9.
    301. Section 880.5120 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5120  Manual adjustable hospital 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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    302. Section 880.5150 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5150  Nonpowered flotation therapy mattress.

* * * * *
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    303. Section 880.5160 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5160  Therapeutic medical binder.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    304. Section 880.5180 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5180  Burn sheet.

* * * * *
    (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 the limitations in Sec. 880.9.
    305. Section 880.5210 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5210  Intravascular catheter securement 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 the limitations in Sec. 880.9.
    306. Section 880.5240 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5240  Medical adhesive tape and adhesive bandage.

* * * * *
    (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 the limitations in Sec. 880.9.
    307. Section 880.5300 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5300  Medical absorbent fiber.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    308. Section 880.5510 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5510  Non-AC-powered patient lift.

* * * * *
    (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 the limitations in Sec. 880.9.
    309. Section 880.5560 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5560  Temperature regulated water mattress.

* * * * *
    (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 the limitations in Sec. 880.9.
    310. Section 880.5630 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5630  Nipple 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 the limitations in Sec. 880.9.
    311. Section 880.5640 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5640  Lamb feeding nipple.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.

[[Page 38805]]

    312. Section 880.5680 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5680  Pediatric position holder.

* * * * *
    (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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    313. Section 880.5740 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5740  Suction snakebite 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 the limitations in Sec. 880.9.
    314. Section 880.5780 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 880.5780  Medical support stocking.

* * * * *
    (b)  *  *  *
    (2) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 880.9. 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, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    315. Section 880.5820 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5820  Therapeutic scrotal support.

* * * * *
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    316. Section 880.5950 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5950  Umbilical occlusion 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 the limitations in Sec. 880.9.
    317. Section 880.6025 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6025  Absorbent tipped applicator.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    318. Section 880.6050 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6050  Ice 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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    319. Section 880.6060 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6060  Medical disposable bedding.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    320. Section 880.6070 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6070  Bed board.

* * * * *
    (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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    321. Section 880.6080 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6080  Cardiopulmonary resuscitation board.

* * * * *
    (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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    322. Section 880.6085 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6085  Hot/cold water bottle.

* * * * *
    (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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    323. Section 880.6140 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6140  Medical chair and table.

* * * * *
    (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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    324. Section 880.6150 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6150  Ultrasonic cleaner for medical instruments.

* * * * *
    (b) Classification. Class I. The device, including any solutions 
intended for use with the device for cleaning and sanitizing the 
instruments, is exempt from the premarket notification procedures in 
subpart E of part 807 of

[[Page 38806]]

this chapter, subject to the limitations in Sec. 880.9.
    325. Section 880.6185 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6185  Cast cover.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    326. Section 880.6190 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6190  Mattress cover for medical purposes.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    327. Section 880.6200 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6200  Ring cutter.

* * * * *
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    328. Section 880.6230 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6230  Tongue depressor.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    329. Section 880.6250 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6250  Patient examination glove.

* * * * *
    (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 the limitations in Sec. 880.9.
    330. Section 880.6265 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6265  Examination gown.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    331. Section 880.6280 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6280  Medical insole.

* * * * *
    (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 the limitations in Sec. 880.9.
    332. Section 880.6320 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6320  AC-powered medical examination light.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 880.9.
    333. Section 880.6350 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6350  Battery-powered medical examination light.

* * * * *
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    334. Section 880.6375 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6375  Patient lubricant.

* * * * *
    (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 the limitations in Sec. 880.9.
    335. Section 880.6430 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6430  Liquid medication dispenser.

* * * * *
    (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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    336. Section 880.6450 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6450  Skin pressure protectors.

* * * * *
    (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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    337. Section 880.6730 is revised to read as follows:


Sec. 880.6730  Body waste receptacle.

    (a) Identification. A body waste receptacle is a device intended 
for medical purposes that is not attached to the body and that is used 
to collect the body wastes of a bed patient.
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    338. Section 880.6760 is amended by revising paragraph (b) to read 
as follows:

[[Page 38807]]

Sec. 880.6760  Protective restraint.

* * * * *
    (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 the limitations in Sec. 880.9.
    339. Section 880.6785 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6785  Manual patient transfer 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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    340. Section 880.6800 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6800  Washers for body waste receptacles.

* * * * *
    (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 the limitations in Sec. 880.9. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    341. Section 880.6820 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6820  Medical disposable scissors.

* * * * *
    (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 the limitations in Sec. 880.9.
    342. Section 880.6900 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6900  Hand-carried stretcher.

* * * * *
    (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 the limitations in Sec. 880.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    343. Section 880.6960 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6960  Irrigating syringe.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.
    344. Section 880.6970 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6970  Liquid crystal vein locator.

* * * * *
    (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 the limitations in Sec. 880.9.
    345. Section 880.6980 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6980  Vein stabilizer.

* * * * *
    (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 the limitations in Sec. 880.9. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.

PART 882--NEUROLOGICAL DIAGNOSTIC DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    347. Section 882.1030 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1030  Ataxiagraph.

* * * * *
    (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 the limitations in Sec. 882.9.
    348. Section 882.1410 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1410  Electroencephalograph electrode/lead tester.

* * * * *
    (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 the limitations in Sec. 882.9.
    349. Section 882.1420 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1420  Electroencephalogram (EEG) signal spectrum analyzer.

* * * * *
    (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 the limitations in Sec. 882.9.
    350. Section 882.1430 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1430  Electroencephalograph test signal generator.

* * * * *
    (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 the limitations in Sec. 882.9.
    351. Section 882.1525 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1525  Tuning fork.

* * * * *
    (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 the limitations in Sec. 882.9. The 
device is also exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.
    352. Section 882.1700 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1700  Percussor.

* * * * *
    (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 the limitations in 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    353. Section 882.1925 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1925  Ultrasonic scanner calibration test block.

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

[[Page 38808]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 882.9.
    354. Section 882.4030 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4030  Skull plate anvil.

* * * * *
    (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 the limitations in Sec. 882.9.
    355. Section 882.4125 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4125  Neurosurgical chair.

* * * * *
    (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 the limitations in Sec. 882.9.
    356. Section 882.4200 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4200  Clip removal instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9.
    357. Section 882.4215 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4215  Clip rack.

* * * * *
    (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 the limitations in Sec. 882.9.
    358. Section 882.4325 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4325  Cranial drill handpiece (brace).

* * * * *
    (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 the limitations in Sec. 882.9.
    359. Section 882.4440 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4440  Neurosurgical headrests.

* * * * *
    (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 the limitations in Sec. 882.9.
    360. Section 882.4500 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4500  Cranioplasty material forming instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9.
    361. Section 882.4525 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4525  Microsurgical instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9.
    362. Section 882.4535 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4535  Nonpowered neurosurgical instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9.
    363. Section 882.4600 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4600  Leukotome.

* * * * *
    (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 the limitations in Sec. 882.9.
    364. Section 882.4900 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.4900  Skullplate screwdriver.

* * * * *
    (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 the limitations in Sec. 882.9.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    366. Section 884.1550 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.1550  Amniotic fluid sampler (amniocentesis tray).

* * * * *
    (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 the limitations in Sec. 884.9.
    367. Section 884.1640 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 884.1640  Culdoscope and accessories.

* * * * *
    (b)  *  *  *
    (2) Class I for culdoscope accessories that are not part of a 
specialized instrument or device delivery system; do not have adapters, 
connectors, channels, or do not have portals for electrosurgical, 
laser, or other power sources. Such culdoscope accessory instruments 
include: lens cleaning brush, biopsy brush, clip applier (without 
clips), applicator, cannula (without trocar or valves), ligature 
carrier/needle holder, clamp/hemostat/grasper, curette, instrument 
guide, ligature passing and knotting instrument, suture needle (without 
suture), retractor, mechanical (noninflatable), snare, stylet, forceps, 
dissector, mechanical (noninflatable) scissors, and suction/irrigation 
probe. The devices subject to this paragraph (b)(2) are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 884.9.
    368. Section 884.1690 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 884.1690  Hysteroscope and accessories.

* * * * *
    (b)  *  *  *
    (2) Class I for hysteroscope accessories that are not part of a 
specialized instrument or device delivery system; do not have adapters, 
connectors, channels, or do not have portals for electrosurgical, 
laser, or other power sources. Such hysteroscope accessory instruments 
include: lens cleaning brush, cannula (without trocar or valves), 
clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, 
mechanical (noninflatable), and scissors. The devices subject to this 
paragraph (b)(2) are exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 884.9.
    369. Section 884.1700 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 884.1700  Hysteroscopic insufflator.

* * * * *
    (b)  *  *  *
    (2) Class I for tubing and tubing/filter fits which only include 
accessory instruments that are not used to effect intrauterine access, 
e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing 
kits used for only intrauterine insufflation. The devices subject to 
this paragraph (b)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 884.9.
    370. Section 884.1720 is amended by revising paragraph (b)(2) to 
read as follows:

[[Page 38809]]

Sec. 884.1720  Gynecologic laparoscope and accessories.

* * * * *
    (b)  *  *  *
    (2) Class I for gynecologic laparoscope accessories that are not 
part of a specialized instrument or device delivery system, do not have 
adapters, connector channels, or do not have portals for 
electrosurgical, lasers, or other power sources. Such gynecologic 
laparosope accessory instruments include: the lens cleaning brush, 
biopsy brush, clip applier (without clips), applicator, cannula 
(without trocar or valves), ligature carrier/needle holder, clamp/
hemostat/grasper, curette, instrument guide, ligature passing and 
knotting instrument, suture needle (without suture), retractor, 
mechanical (noninflatable), snare, stylet, forceps, dissector, 
mechanical (noninflatable), scissors, and suction/irrigation probe. The 
devices subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 884.9.
    371. Section 884.1730 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 884.1730  Laparoscopic insufflator.

* * * * *
    (b)  *  *  *
    (2) Class I for tubing and tubing/filter kits which include 
accessory instruments that are not used to effect intra-abdominal 
insufflation (pneumoperitoneum). The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in 
Sec. 884.9.
    372. Section 884.2900 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.2900  Fetal 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 the limitations in Sec. 884.9.
    373. Section 884.2980 is amended by revising paragraph (a)(2) to 
read as follows:


Sec. 884.2980  Telethermographic system.

    (a)  *  *  *
    (2) Classification. Class I (general controls). The devices subject 
to this paragraph (a)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 884.9.
* * * * *
    374. Section 884.2982 is amended by revising paragraph (a)(2) to 
read as follows:


Sec. 884.2982  Liquid crystal thermographic system.

    (a)  *  *  *
    (2) Classification. Class I (general controls). The devices subject 
to this paragraph (a)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 884.9.
* * * * *
    375. Section 884.4520 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.4520  Obstetric-gynecologic general manual instrument.

* * * * *
    (b) Classification. Class I (general controls). The devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 884.9.
    376. Section 884.4530 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 884.4530  Obstetric-gynecologic specialized manual instrument.

* * * * *
    (b)  *  *  *
    (2) Class I for the amniotome, uterine curette, cervical dilator 
(fixed-size bougies), cerclage needle, IUD remover, uterine sound, and 
gynecological biopsy forceps. The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in 
Sec. 884.9.
    377. Section 884.5150 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.5150  Nonpowered breast pump.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 884.9, if the device is 
using either a bulb or telescoping mechanism which does not develop 
more than 250 mm Hg suction, and the device materials that contact 
breast or breast milk do not produce cytotoxicity, irritation, or 
sensitization effects.
    378. Section 884.5425 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 884.5425  Scented or scented deodorized menstrual pad.

* * * * *
    (b) Classification. (1) Class I (general controls) for menstrual 
pads made of common cellulosic and synthetic material with an 
established safety profile. The devices subject to this paragraph 
(b)(1) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in 
Sec. 884.9. This exemption does not include the [intralabial] pads and 
reusable menstrual pads.
* * * * *
    379. Section 884.5900 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 884.5900  Therapeutic vaginal douche apparatus.

* * * * *
    (b)  *  *  *
    (2) Class I if the device is operated by gravity feed. Devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 884.9.
    380. Section 884.5920 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.5920  Vaginal insufflator.

* * * * *
    (b) Classification. Class I. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 884.9.
    381. Section 884.6190 is amended by revising paragraph (b) to read 
as follows:


Sec. 884.6190  Assisted reproductive microscopes and microscope 
accessories.

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

PART 886--OPHTHALMIC DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    383. Section 886.1040 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1040  Ocular 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 the limitations in Sec. 886.9.
    384. Section 886.1050 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1050  Adaptometer (biophotometer).

* * * * *
    (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 the limitations in Sec. 886.9.

[[Page 38810]]

    385. Section 886.1070 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1070  Anomaloscope.

* * * * *
    (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 the limitations in Sec. 886.9.
    386. Section 886.1090 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1090  Haidlinger brush.

* * * * *
    (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 the limitations in Sec. 886.9.
    387. Section 886.1140 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1140  Ophthalmic chair.

* * * * *
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in 
Sec. 886.9. The manual device is also exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.
    388. Section 886.1150 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1150  Visual acuity chart.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    389. Section 886.1160 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1160  Color vision plate 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 the limitations in Sec. 886.9.
    390. Section 886.1170 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1170  Color vision tester.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    391. Section 886.1190 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1190  Distometer.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    392. Section 886.1200 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1200  Optokinetic drum.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    393. Section 886.1250 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1250  Euthyscope.

* * * * *
    (b) Classification. Class I for the battery powered device. The 
battery powered device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 886.9. Class II for the AC-powered device.
    394. Section 886.1270 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1270  Exophthalmometer.

* * * * *
    (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 the limitations in Sec. 886.9.
    395. Section 886.1290 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1290  Fixation 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 the limitations in Sec. 886.9.
    396. Section 886.1320 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1320  Fornixscope.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    397. Section 886.1330 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1330  Amsler 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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    398. Section 886.1340 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1340  Haploscope.

* * * * *
    (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 the limitations in Sec. 886.9.
    399. Section 886.1375 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1375  Bagolini lens.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    400. Section 886.1380 is amended by revising paragraph (b) to read 
as follows:

[[Page 38811]]

Sec. 886.1380  Diagnostic condensing lens.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    401. Section 886.1390 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1390  Flexible diagnostic Fresnel lens.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    402. Section 886.1395 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1395  Diagnostic Hruby fundus lens.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    403. Section 886.1400 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1400  Maddox lens.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    404. Section 886.1405 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1405  Ophthalmic trial lens set.

* * * * *
    (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 the limitations in Sec. 886.9.
    405. Section 886.1410 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1410  Ophthalmic trial lens clip.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 886.9.
    406. Section 886.1415 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1415  Ophthalmic trial lens frame.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    407. Section 886.1420 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1420  Ophthalmic lens gauge.

* * * * *
    (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 the limitations in Sec. 886.9.
    408. Section 886.1425 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1425  Lens measuring instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 886.9.
    409. Section 886.1430 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1430  Ophthalmic contact lens radius measuring 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 the limitations in Sec. 886.9.
    410. Section 886.1435 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1435  Maxwell spot.

* * * * *
    (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 the limitations in Sec. 886.9.
    411. Section 886.1450 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1450  Corneal radius measuring 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 the limitations in Sec. 886.9, only 
when the device does not include computer software in the unit or 
topographers.
    412. Section 886.1460 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1460  Stereopsis measuring instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    413. Section 886.1500 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1500  Headband mirror.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    414. Section 886.1605 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1605  Perimeter.

* * * * *
    (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 the limitations in Sec. 886.9 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, with respect to general requirements

[[Page 38812]]

concerning records, and Sec. 820.198, with respect to complaint files.
    415. Section 886.1650 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1650  Ophthalmic bar prism.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    416. Section 886.1655 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1655  Ophthalmic Fresnel prism.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    417. Section 886.1660 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1660  Gonioscopic prism.

* * * * *
    (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 the limitations in Sec. 886.9.
    418. Section 886.1665 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1665  Ophthalmic rotary prism.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    419. Section 886.1680 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1680  Ophthalmic projector.

* * * * *
    (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 the limitations in Sec. 886.9.
    420. Section 886.1690 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1690  Pupillograph.

* * * * *
    (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 the limitations in Sec. 886.9.
    421. Section 886.1700 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1700  Pupillometer.

* * * * *
    (b) Classification. Class I (general controls). The AC-powered 
device and the manual device are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 886.9. The manual device is also exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
    422. Section 886.1750 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1750  Skiascopic rack.

* * * * *
    (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 the limitations in Sec. 886.9.
    423. Section 886.1760 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1760  Ophthalmic refractometer.

* * * * *
    (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 the limitations in Sec. 886.9.
    424. Section 886.1770 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1770  Manual refractor.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    425. Section 886.1790 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1790  Nearpoint ruler.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    426. Section 886.1800 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1800  Schirmer strip.

* * * * *
    (b) Classification. Class I (general controls). If the device is 
made of the same materials that were used in the device before May 28, 
1976, the device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 886.9.
    427. Section 886.1810 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1810  Tangent screen (campimeter).

* * * * *
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    428. Section 886.1840 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1840  Simulatan (including crossed cylinder).

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    429. Section 886.1860 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1860  Ophthalmic instrument stand.

* * * * *

[[Page 38813]]

    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    430. Section 886.1870 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1870  Stereoscope.

* * * * *
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    431. Section 886.1880 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1880  Fusion and stereoscopic target.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    432. Section 886.1905 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1905  Nystagmus tape.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    433. Section 886.1910 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1910  Spectacle dissociation test system.

* * * * *
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
    434. Section 886.1945 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.1945  Transilluminator.

* * * * *
    (b) Classification. Class I for the battery-powered device. The 
battery-powered device is also exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 886.9. Class II for the AC-powered device.
    435. Section 886.3200 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.3200  Artificial eye.

* * * * *
    (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 the limitations in Sec. 886.9, if the 
device is made from the same materials, has the same chemical 
composition, and uses the same manufacturing processes as currently 
legally marketed devices.
    436. Section 886.4230 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4230  Ophthalmic knife test drum.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    437. Section 886.4250 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4250  Ophthalmic electrolysis unit.

* * * * *
    (b) Classification. Class I for the battery-powered device. Class 
II for the AC-powered device. The battery-powered device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 886.9.
    438. Section 886.4335 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4335  Operating headlamp.

* * * * *
    (b) Classification. Class I for the battery-powered device. Class 
II for the AC-powered device. The battery-powered device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 886.9.
    439. Section 886.4350 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4350  Manual ophthalmic surgical instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 886.9.
    440. Section 886.4360 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4360  Ocular surgery irrigation 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 the limitations in Sec. 886.9.
    441. Section 886.4445 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4445  Permanent magnet.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    442. Section 886.4570 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4570  Ophthalmic surgical marker.

* * * * *
    (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 the limitations in Sec. 886.9.
    443. Section 886.4770 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4770  Ophthalmic operating spectacles (loupes).

* * * * *

[[Page 38814]]

    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    444. Section 886.4855 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.4855  Ophthalmic instrument table.

* * * * *
    (b) Classification. Class I (general controls). The AC-powered 
device and the manual device are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 886.9. The manual device is also exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
    445. Section 886.5120 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5120  Low-power binocular loupe.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    446. Section 886.5420 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5420  Contact lens inserter/remover.

* * * * *
    (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 the limitations in Sec. 886.9.
    447. Section 886.5540 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5540  Low-vision magnifier.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    448. Section 886.5600 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5600  Ptosis crutch.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    449. Section 886.5800 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5800  Ophthalmic bar reader.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    450. Section 886.5810 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5810  Ophthalmic prism reader.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    451. Section 886.5820 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5820  Closed-circuit television reading 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 the limitations in Sec. 886.9.
    452. Section 886.5840 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5840  Magnifying spectacles.

* * * * *
    (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 the limitations in Sec. 886.9.
    453. Section 886.5842 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5842  Spectacle frame.

* * * * *
    (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 the limitations in Sec. 886.9.
    454. Section 886.5844 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5844  Prescription spectacle lens.

* * * * *
    (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 the limitations in Sec. 886.9.
    455. Section 886.5870 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5870  Low-vision telescope.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    456. Section 886.5900 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5900  Electronic vision aid.

* * * * *
    (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 the limitations in Sec. 886.9.
    457. Section 886.5910 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5910  Image intensification vision aid.

* * * * *
    (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 the limitations in Sec. 886.9. 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, with respect to general requirements concerning

[[Page 38815]]

records, and Sec. 820.198, with respect to complaint files.
    458. Section 886.5915 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.5915  Optical vision aid.

* * * * *
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

PART 888--ORTHOPEDIC DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    460. Section 888.1100 is amended by revising paragraph (b)(2) to 
read as follows:


Sec. 888.1100  Arthroscope.

* * * * *
    (b)  *  *  *
    (2) Class I for the following manual arthroscopic instruments: 
cannulas, currettes, drill guides, forceps, gouges, graspers, knives, 
obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, 
suture passers, suture knotpushers, suture punches, switching rods, and 
trocars. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 888.9.
    461. Section 888.1520 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.1520  Nonpowered goniometer.

* * * * *
    (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 the limitations in Sec. 888.9.
    462. Section 888.3000 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.3000  Bone cap.

* * * * *
    (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 the limitations in Sec. 888.9.
    463. Section 888.4150 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4150  Calipers 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 the limitations in Sec. 888.9.
    464. Section 888.4200 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4200  Cement dispenser.

* * * * *
    (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 the limitations in Sec. 888.9.
    465. Section 888.4210 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4210  Cement mixer 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 the limitations in Sec. 888.9.
    466. Section 888.4220 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4220  Cement monomer vapor evacuator.

* * * * *
    (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 the limitations in Sec. 888.9.
    467. Section 888.4230 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4230  Cement ventilation 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 the limitations in Sec. 888.9.
    468. Section 888.4300 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4300  Depth gauge 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 the limitations in Sec. 888.9.
    469. Section 888.4540 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4540  Orthopedic manual surgical instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 888.9.
    470. Section 888.4600 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4600  Protractor 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 the limitations in Sec. 888.9.
    471. Section 888.4800 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.4800  Template 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 the limitations in Sec. 888.9.
    472. Section 888.5850 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.5850  Nonpowered orthopedic traction apparatus 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 the limitations in Sec. 888.9. 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, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.
    473. Section 888.5890 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.5890  Noninvasive traction component.

* * * * *
    (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 the limitations in Sec. 888.9. 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, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.
    474. Section 888.5940 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.5940  Cast component.

* * * * *
    (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 the limitations in Sec. 888.9. 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, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.

[[Page 38816]]

    475. Section 888.5960 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.5960  Cast removal instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 888.9.
    476. Section 888.5980 is amended by revising paragraph (b) to read 
as follows:


Sec. 888.5980  Manual cast application and removal instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 888.9. 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, regarding general requirements concerning records, and 
Sec. 820.198, regarding complaint files.

PART 890--PHYSICAL MEDICINE DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    478. Section 890.1575 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1575  Force-measuring platform.

* * * * *
    (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 the limitations in Sec. 890.9.
    479. Section 890.1600 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1600  Intermittent pressure measurement 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 the limitations in Sec. 890.9.
    480. Section 890.1615 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1615  Miniature pressure transducer.

* * * * *
    (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 the limitations in Sec. 890.9.
    481. Section 890.3025 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3025  Prosthetic and orthotic accessory.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    482. Section 890.3075 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3075  Cane.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    483. Section 890.3100 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3100  Mechanical chair.

* * * * *
    (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 the limitations in Sec. 890.9.
    484. Section 890.3150 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3150  Crutch.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    485. Section 890.3175 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3175  Flotation cushion.

* * * * *
    (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 the limitations in Sec. 890.9.
    486. Section 890.3410 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3410  External limb orthotic component.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    487. Section 890.3420 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3420  External limb prosthetic component.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    488. Section 890.3475 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3475  Limb orthosis.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    489. Section 890.3490 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3490  Truncal orthosis.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.

[[Page 38817]]

    490. Section 890.3520 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3520  Plinth.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    491. Section 890.3640 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3640  Arm sling.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    492. Section 890.3665 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3665  Congenital hip dislocation abduction 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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    493. Section 890.3675 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3675  Denis Brown 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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    494. Section 890.3700 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3700  Nonpowered communication 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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    495. Section 890.3750 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3750  Mechanical table.

* * * * *
    (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 the limitations in Sec. 890.9.
    496. Section 890.3760 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3760  Powered table.

* * * * *
    (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 the limitations in Sec. 890.9.
    497. Section 890.3790 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3790  Cane, crutch, and walker tips and pads.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    498. Section 890.3825 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3825  Mechanical walker.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    499. Section 890.3910 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3910  Wheelchair accessory.

* * * * *
    (b) Classification. Class I (general controls). If the device is 
not intended for use as a protective restraint as defined in 
Sec. 880.6760 of this chapter, it is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 890.9. 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, regarding general 
requirements concerning records, and Sec. 820.198, regarding complaint 
files.
    500. Section 890.3920 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3920  Wheelchair component.

* * * * *
    (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 the limitations in Sec. 890.9.
    501. Section 890.3940 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3940  Wheelchair platform scale.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    502. Section 890.5050 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5050  Daily activity assist 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 the limitations in Sec. 890.9. If the 
device is not labeled or otherwise represented as sterile, 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, 
regarding general requirements concerning records and Sec. 820.198, 
regarding complaint files.

[[Page 38818]]

    503. Section 890.5125 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5125  Nonpowered sitz bath.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    504. Section 890.5350 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5350  Exercise component.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    505. Section 890.5370 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5370  Nonmeasuring exercising equipment.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    506. Section 890.5380 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5380  Powered exercise equipment.

* * * * *
    (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 the limitations in Sec. 890.9.
    507. Section 890.5410 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5410  Powered finger exerciser.

* * * * *
    (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 the limitations in Sec. 890.9.
    508. Section 890.5660 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5660  Therapeutic massager.

* * * * *
    (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 the limitations in Sec. 890.9.
    509. Section 890.5730 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5730  Moist heat pack.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    510. Section 890.5765 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5765  Pressure-applying 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 the limitations in Sec. 890.9.
    511. Section 890.5925 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5925  Traction accessory.

* * * * *
    (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 the limitations in Sec. 890.9. 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, regarding general requirements concerning records and 
Sec. 820.198, regarding complaint files.
    512. Section 890.5940 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5940  Chilling unit.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 890.9
    513. Section 890.5950 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5950  Powered heating unit.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 890.9.
    514. Section 890.5975 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5975  Therapeutic vibrator.

* * * * *
    (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 the limitations in Sec. 890.9.

PART 892--RADIOLOGY DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    516. Section 892.1100 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1100  Scintillation (gamma) camera.

* * * * *
    (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 the limitations in Sec. 892.9.
    517. Section 892.1110 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1110  Positron camera.

* * * * *
    (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 the limitations in Sec. 892.9.
    518. Section 892.1130 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1130  Nuclear whole body counter.

* * * * *
    (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 the limitations in Sec. 892.9.
    519. 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 the limitations in Sec. 892.9.
    520. Section 892.1370 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1370  Nuclear anthropomorphic phantom.

* * * * *

[[Page 38819]]

    (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 the limitations in Sec. 892.9.
    521. Section 892.1380 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1380  Nuclear flood source phantom.

* * * * *
    (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 the limitations in Sec. 892.9.
    522. Section 892.1400 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1400  Nuclear sealed calibration source.

* * * * *
    (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 the limitations in Sec. 892.9.
    523. Section 892.1420 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1420  Radionuclide test pattern phantom.

* * * * *
    (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 the limitations in Sec. 892.9.
    524. Section 892.1640 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1640  Radiographic film marking 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 the limitations in Sec. 892.9.
    525. Section 892.1700 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1700  Diagnostic x-ray high voltage generator.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 892.9.
    526. Section 892.1760 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1760  Diagnostic x-ray tube housing assembly.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 892.9.
    527. Section 892.1770 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1770  Diagnostic x-ray tube mount.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 892.9.
    528. Section 892.1830 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1830  Radiologic patient cradle.

* * * * *
    (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 the limitations in Sec. 892.9.
    529. Section 892.1840 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1840  Radiographic film.

* * * * *
    (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 the limitations in Sec. 892.9.
    530. Section 892.1880 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1880  Wall-mounted radiographic cassette holder.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 892.9.
    531. Section 892.1920 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1920  Radiographic head holder.

* * * * *
    (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 the limitations in Sec. 892.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    532. Section 892.1940 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1940  Radiologic quality assurance instrument.

* * * * *
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 892.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    533. Section 892.1950 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1950  Radiographic anthropomorphic phantom.

* * * * *
    (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 the limitations in Sec. 892.9. 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, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
    534. Section 892.5740 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.5740  Radionuclide teletherapy source.

* * * * *
    (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 the limitations in Sec. 892.9.
    535. Section 892.5780 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.5780  Light beam patient position indicator.

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

    Dated: June 21, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-17867 Filed 7-24-01; 8:45 am]
BILLING CODE 4160-01-S