[Federal Register: September 10, 2001 (Volume 66, Number 175)]
[Rules and Regulations]
[Page 46951-46953]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se01-5]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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