[Federal Register Volume 66, Number 175 (Monday, September 10, 2001)]
[Rules and Regulations]
[Pages 46951-46953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 872, 878, 880, 882, 884, and 892

[Docket No. 01N-0073]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: In the Federal Register of July 25, 2001 (66 FR 38786), the 
Food and Drug Administration (FDA) amended its medical device 
classification regulations for class I devices to specifically add a 
reference to the general limitations on exemptions from premarket 
notification requirements from each generic device classified as exempt 
in each section. As published, an exemption from the premarket 
notification requirements and a reference to the general limitations 
language was inadvertently added to 12 device classifications that 
should not include the reference. These devices are not exempt from the 
requirements of premarket notification. This document corrects those 
errors.

DATES: This rule is effective September 10, 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.

[[Page 46952]]


SUPPLEMENTARY INFORMATION:

I. Background

    Provisions under section 206 of the Food and Drug Administration 
Modernization Act (FDAMA) exempt certain class I devices from the 
premarket notification requirements of the Federal Food, Drug, and 
Cosmetic Act (the act). To implement the new law, FDA evaluated all 
class I devices to determine which device types should become exempt 
under the new provisions and which device types should remain subject 
to the requirements of 510(k) of the act (21 U.S.C. 360(k)). FDA then 
amended its classification regulations through a series of publications 
in the Federal Register (63 FR 63222, November 12, 1998; 65 FR 2296, 
January 14, 2000; 63 FR 5387, February 2, 1998; and 66 FR 38786). The 
most recent amendment (66 FR 38786) revised statutory citations for 
over 500 devices in order to reference the limitation provisions found 
in each device classification regulation for devices that were exempt 
from the premarket notification requirements for clarity and 
convenience. During preparation of the final rule, however, certain 
devices were inadvertently included in a list of devices to be amended, 
and were erroneously changed by adding the limitations language and an 
exemption from premarket notification. This document corrects those 
errors.

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 this 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 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 negative economic impact on a substantial number of small 
entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4) 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 872, 878, 880, 882, and 884

    Medical devices.

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 
872, 878, 880, 882, 884, and 892 are amended as follows:

PART 872--DENTAL DEVICES

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

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

    2. 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).

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

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

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

    4. 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).

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

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

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

    6. 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 good manufacturing practice regulation 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.

    7. 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).

    8. Section 880.6375 is amended by revising paragraph (b) to read as 
follows:


Sec. 880.6375  Patient lubricant.

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

    9. Section 880.6760 is amended by revising paragraph (b) to read as 
follows:


Sec. 880.6760  Protective restraint.

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

PART 882--NEUROLOGICAL DEVICES

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

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

    11. Section 882.1030 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.1030  Ataxiagraph.

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

[[Page 46953]]


    12. 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).

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

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

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

    14. 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).
* * * * *

    15. 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).
* * * * *

PART 892--RADIOLOGY DEVICES

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

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

    17. 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).

    18. Section 892.1110 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1110  Positron camera.

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

    Dated: August 23, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-22577 Filed 9-7-01; 8:45 am]
BILLING CODE 4160-01-S