[Federal Register Volume 73, Number 119 (Thursday, June 19, 2008)]
[Rules and Regulations]
[Pages 34857-34861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13915]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 800, 801, 808, 814, 821, 860, 876, 882, 884, 886, 890,
1005, and 1010
[Docket No. FDA-2008-N-0332]
Medical 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 certain
medical device regulations to correct typographical errors and to
ensure accuracy and clarity in the agency's regulations.
DATES: This rule is effective June 19, 2008.
FOR FURTHER INFORMATION CONTACT: Paul S. Gadiock, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-2343.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is amending its regulations in parts 800, 801, 808, 814, 821,
860, 876, 882, 884, 886, 890, 1005, and 1010 (21 CFR parts 800, 801,
808, 814, 821, 860, 876, 882, 884, 886, 890, 1005, and 1010) to correct
typographical errors and to update addresses, telephone numbers, and
wording to ensure accuracy and clarity in the agency's medical device
regulations.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because these
errors are nonsubstantive.
II. Highlights of the Final Rule
FDA is making changes to correct typographical and other minor
errors in certain device regulations in parts 800, 801, 808, 814, 821,
860, 876, 882, 884, 886, 890, 1005, and 1010.
1. FDA is revising Sec. 800.12(d) by removing ``This information
collection requirement has been approved by the Office of Management
and Budget under number 0910-0150.''
2. FDA is revising Sec. 801.420(d) by replacing ``Bureau of
Medical Devices and Diagnostic Products, Division of Compliance, HFK-
116, 8757 Georgia
[[Page 34858]]
Ave., Silver Spring, MD 20910'' with ``Office of Compliance, Division
of Enforcement A, 2094 Gaither Rd., Rockville, MD 20850.''
3. FDA is revising Sec. 808.1(d)(9) by replacing ``the Radiation
Control for Health and Safety Act of 1968 (Pub. L. 90-602 (42 U.S.C.
263b et seq.))'' with ``Subchapter C--Electronic Product Radiation
Control of the Federal Food, Drug, and Cosmetic Act (formerly the
Radiation Control for Health and Safety Act of 1968).'' FDA is also
replacing ``Atomic Energy act'' with ``Atomic Energy Act.''
4. FDA is revising Sec. 814.20(b)(5) by replacing ``the Radiation
Control for Health and Safety Act of 1968 (42 U.S.C. 263b et seq.)''
with ``section 534 of Subchapter C--Electronic Product Radiation
Control of the Federal Food, Drug, and Cosmetic Act (formerly the
Radiation Control for Health and Safety Act of 1968).''
5. FDA is revising Sec. 814.45(b) by replacing ``515(d)(3)'' with
``515(d)(4).''
6. FDA is revising Sec. 821.1(c) by replacing ``501(t)(2)'' with
``502(t)(2).''
7. FDA is revising Sec. 860.134(a) by replacing ``513(f)(2)'' with
``513(f)(3).''
8. FDA is revising Sec. 876.5250(b)(2) by replacing ``subject to
the limitations in Sec. 876.9'' with ``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.'' FDA is also
replacing ``regulations'' with ``requirements of the quality system
regulation.''
9. FDA is revising Subpart E of the Table of Contents of Part 882
by replacing ``882.4700 Neurosurgical paddle'' with ``882.4700
Neurosurgical paddie.''
10. FDA is revising Subpart F of the Table of Contents of Part 882
by replacing ``882.5800 Cranial electrotheraphy stimulator'' with
``882.5800 Cranial electrotherapy stimulator.''
11. FDA is revising the section heading in Sec. 882.5800 by
replacing ``electrotheraphy'' with ``electrotherapy.''
12. FDA is revising Sec. 882.5800(a) by replacing
``electrotheraphy'' with ``electrotherapy.''
13. FDA is revising Sec. 884.5435(b) by replacing ``interlabial''
with ``intralabial.''
14. FDA is revising Sec. 886.1 by adding paragraph (e) reading
``Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.''
15. FDA is revising Sec. 890.1 by adding paragraph (e) reading
``Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.''
16. FDA is revising Sec. 1005.11 by replacing ``the Radiation
Control for Health and Safety Act of 1968'' with ``Subchapter C--
Electronic Product Radiation Control of the Federal Food, Drug, and
Cosmetic Act (formerly the Radiation Control for Health and Safety Act
of 1968).''
17. FDA is revising Sec. 1005.25(a) by replacing ``section 360(d)
of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C.
263h(d))'' with ``section 536(d) of Subchapter C--Electronic Product
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly
the Radiation Control for Health and Safety Act of 1968) (21 U.S.C.
360mm(d)).''
18. FDA is revising Sec. 1005.25(c) by replacing ``section 360(d)
of the Radiation Control for Health and Safety Act of 1968'' with
``section 536(d) of Subchapter C--Electronic Product Radiation Control
of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation
Control for Health and Safety Act of 1968) (21 U.S.C. 360mm(d)).''
19. FDA is revising Sec. 1010.1 by replacing ``section 358 of the
Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f)''
with ``section 534 of Subchapter C--Electronic Product Radiation
Control of the Federal Food, Drug, and Cosmetic Act (formerly the
Radiation Control for Health and Safety Act of 1968) (21 U.S.C.
360kk).''
20. FDA is revising Sec. 1010.4(a)(1) by replacing ``the Radiation
Control for Health and Safety Act of 1968'' with ``Subchapter C--
Electronic Product Radiation Control of the Federal Food, Drug, and
Cosmetic Act (formerly the Radiation Control for Health and Safety Act
of 1968).''
III. Environmental Impact
The agency has determined under 21 CFR 25.30(i) that this final
rule 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.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), 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 not a significant regulatory action 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 corrects only typographical and
nonsubstantive errors in existing regulations and does not change in
any way how devices are regulated, the agency certifies that the 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, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
V. Paperwork Reduction Act of 1995
FDA has determined that 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.
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VII. The Technical Amendments
This rule updates and corrects existing regulations to ensure
accuracy
[[Page 34859]]
and clarity. This administrative action is limited to correcting
typographical errors; updating changes in addresses, web site
locations, and telephone numbers; and clarifying regulation
terminology. It makes no changes in substantive requirements.
For the effective date of this final rule, see the DATES section of
this document. Because this final rule is an administrative action, FDA
has determined that it has no substantive impact on the public. It
imposes no costs, and merely makes technical administrative changes in
the Code of Federal Regulations (CFR) for the convenience of 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.
List of Subjects
21 CFR Part 800
Administrative practice and procedure, Medical devices, Ophthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.
21 CFR Part 801
Labeling, Medical devices, Reporting and recordkeeping
requirements.
21 CFR Part 808
Intergovernmental relations, Medical devices.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 821
Imports, Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 860
Administrative practice and procedure, Medical devices.
21 CFR Part 876
Medical devices.
21 CFR Part 882
Medical devices.
21 CFR Part 884
Medical devices.
21 CFR Part 886
Medical devices, Ophthalmic goods and services.
21 CFR Part 890
Medical devices.
21 CFR Part 1005
Administrative practice and procedure, Electronic products,
Imports, Radiation protection, Surety bonds.
21 CFR Part 1010
Administrative practice and procedure, Electronic products,
Exports, Radiation protection.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
800, 801, 808, 814, 821, 860, 876, 882, 884, 886, 890, 1005, and 1010
are amended as follows:
PART 800--GENERAL
0
1. The authority citation for 21 CFR part 800 continues to read as
follows:
Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k,
361, 362, 371.
Sec. 800.12 [Amended]
0
2. In Sec. 800.12, paragraph (d) is amended by removing the last
sentence.
PART 801--LABELING
0
3. The authority citation for 21 CFR part 801 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
0
4. In Sec. 801.420, paragraph (d) is revised to read as follows:
Sec. 801.420 Hearing aid devices; professional and patient labeling.
* * * * *
(d) Submission of all labeling for each type of hearing aid. Any
manufacturer of a hearing aid described in paragraph (a) of this
section shall submit to the Food and Drug Administration, Office of
Compliance, Division of Enforcement A, 2094 Gaither Rd., Rockville, MD
20850, a copy of the User Instructional Brochure described in paragraph
(c) of this section and all other labeling for each type of hearing aid
on or before August 15, 1977.
PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL
MEDICAL DEVICE REQUIREMENTS
0
5. The authority citation for 21 CFR part 808 continues to read as
follows:
Authority: 21 U.S.C. 360j, 360k, 371.
0
6. In Sec. 808.1, paragraph (d)(9) is revised to read as follows:
Sec. 808.1 Scope.
* * * * *
(d) * * *
(9) Section 521(a) does not preempt State or local requirements of
the types that have been developed under the Atomic Energy Act of 1954
(42 U.S.C. 2011 note), as amended, Subchapter C--Electronic Product
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly
the Radiation Control for Health and Safety Act of 1968), and other
Federal statutes, until such time as the Food and Drug Administration
issues specific requirements under the Federal Food, Drug, and Cosmetic
Act applicable to these types of devices.
* * * * *
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
7. The authority citation for 21 CFR part 814 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
0
8. In Sec. 814.20, paragraph (b)(5) is revised to read as follows:
Sec. 814.20 Application.
* * * * *
(b) * * *
(5) Reference to any performance standard under section 514 of the
act or under section 534 of Subchapter C--Electronic Product Radiation
Control of the Federal Food, Drug, and Cosmetic Act (formerly the
Radiation Control for Health and Safety Act of 1968) in effect or
proposed at the time of the submission and to any voluntary standard
that is relevant to any aspect of the safety or effectiveness of the
device and that is known to or that should reasonably be known to the
applicant. The applicant shall--
(i) Provide adequate information to demonstrate how the device
meets, or justify any deviation from, any performance standard
established under section 514 of the act or under section 534 of
Subchapter C--Electronic Product Radiation Control of the Federal Food,
Drug, and Cosmetic Act (formerly the Radiation Control for Health and
Safety Act of 1968), and
(ii) Explain any deviation from a voluntary standard.
* * * * *
0
9. In Sec. 814.45, paragraph (b) is amended by revising the last
sentence to read as follows:
Sec. 814.45 Denial of approval of a PMA.
* * * * *
(b) * * * The order will include a notice of an opportunity to
request review under section 515(d)(4) of the act.
* * * * *
[[Page 34860]]
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS
0
10. The authority citation for 21 CFR part 821 continues to read as
follows:
Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371,
374.
0
11. In Sec. 821.1, paragraph (c) is revised to read as follows:
Sec. 821.1 Scope.
* * * * *
(c) The primary burden for ensuring that the tracking system works
rests upon the manufacturer. A manufacturer or any other person,
including a distributor, final distributor, or multiple distributor,
who distributes a device subject to tracking, who fails to comply with
any applicable requirement of section 519(e) of the act or of this
part, or any person who causes such failure, misbrands the device
within the meaning of section 502(t)(2) of the act and commits a
prohibited act within the meaning of sections 301(e) and 301(q)(1)(B)
of the act.
* * * * *
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES
0
12. The authority citation for 21 CFR part 860 continues to read as
follows:
Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
0
13. In Sec. 860.134, paragraph (a) is amended by revising the first
sentence of the introductory text to read as follows:
Sec. 860.134 Procedures for ``new devices'' under section 513(f) of
the act and reclassification of certain devices.
(a) Section 513(f)(3) of the act applies to proceedings for
reclassification of a device currently in class III by operation of
section 513(f)(1) of the act. * * *
* * * * *
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
14. 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.
0
15. In Sec. 876.5250, paragraph (b)(2) is revised to read as follows:
Sec. 876.5250 Urine collector and accessories.
* * * * *
(b) * * *
(2) Class I (general controls). For a urine collector and
accessories not intended to be connected to an indwelling catheter, the
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. If the device is not labeled or otherwise represented as
sterile, it is exempt from the current good manufacturing practice
requirements of the quality system 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.
PART 882--NEUROLOGICAL DEVICES
0
16. The authority citation for 21 CFR part 882 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
17. In the Table of Contents of Part 882, in Subpart E, Sec. 882.4700
is amended by removing the word ``paddle'' and adding in its place the
word ``paddie''.
0
18. In the Table of Contents of Part 882, in Subpart F, Sec. 882.5800
is amended by removing the word ``electrotheraphy'' and by adding in
its place the word ``electrotherapy''.
0
19. In Sec. 882.5800, the section heading and paragraph (a) are
revised to read as follows:
Sec. 882.5800 Cranial electrotherapy stimulator.
(a) Identification. A cranial electrotherapy stimulator is a device
that applies electrical current to a patient's head to treat insomnia,
depression, or anxiety.
* * * * *
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
0
20. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
21. In Sec. 884.5435, paragraph (b) is amended by revising the last
sentence to read as follows:
Sec. 884.5435 Unscented menstrual pad.
* * * * *
(b) * * * This exemption does not include the intralabial pads and
reusable menstrual pads.
PART 886--OPHTHALMIC DEVICES
0
22. The authority citation for 21 CFR part 886 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
23. Section 886.1 is amended by adding paragraph (e) to read as
follows:
Sec. 886.1 Scope.
* * * * *
(e) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.
PART 890--PHYSICAL MEDICINE DEVICES
0
24. The authority citation for 21 CFR part 890 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
25. Section 890.1 is amended by adding paragraph (e) to read as
follows:
Sec. 890.1 Scope.
* * * * *
(e) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.
PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS
0
26. The authority citation for 21 CFR part 1005 continues to read as
follows:
Authority: 42 U.S.C. 263d, 263h.
0
27. Section 1005.11 is revised to read as follows:
Sec. 1005.11 Payment for samples.
The Department of Health and Human Services will pay for all import
samples of electronic products rendered unsalable as a result of
testing, or will pay the reasonable costs of repackaging such samples
for sale, if the samples are found to be in compliance with the
requirements of Subchapter C--Electronic Product Radiation Control of
the Federal Food, Drug, and Cosmetic Act (formerly the Radiation
Control for Health and Safety Act of 1968). Billing for reimbursement
shall be made by the owner or consignee to the Center for Devices and
Radiological Health, 5600 Fishers Lane, Rockville, MD 20857. Payment
for samples will not be made if the sample is found to be in violation
of the Act, even though subsequently brought into compliance pursuant
to terms specified in a notice of permission issued under Sec.
1005.22.
0
28. Section 1005.25 is amended by revising paragraph (a) and the first
sentence of paragraph (c) to read as follows:
Sec. 1005.25 Service of process on manufacturers.
(a) Every manufacturer of electronic products, prior to offering
such product for importation into the United States, shall designate a
permanent resident of the United States as the manufacturer's agent
upon whom service of all processes, notices, orders, decisions, and
requirements may be made for and
[[Page 34861]]
on behalf of the manufacturer as provided in section 536(d) of
Subchapter C--Electronic Product Radiation Control of the Federal Food,
Drug, and Cosmetic Act (formerly the Radiation Control for Health and
Safety Act of 1968) (21 U.S.C. 360mm(d)) and this section. The agent
may be an individual, a firm, or a domestic corporation. For purposes
of this section, any number of manufacturers may designate the same
agent.
* * * * *
(c) Service of any process, notice, order, requirement, or decision
specified in section 536(d) of Subchapter C--Electronic Product
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly
the Radiation Control for Health and Safety Act of 1968) (21 U.S.C.
360mm(d)) may be made by registered or certified mail addressed to the
agent with return receipt requested, or in any other manner authorized
by law. * * *
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
0
29. The authority citation for 21 CFR part 1010 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42
U.S.C. 263b-263n.
0
30. Section 1010.1 is revised to read as follows:
Sec. 1010.1 Scope.
The standards listed in this subchapter are prescribed pursuant to
section 534 of Subchapter C--Electronic Product Radiation Control of
the Federal Food, Drug, and Cosmetic Act (formerly the Radiation
Control for Health and Safety Act of 1968) (21 U.S.C. 360kk) and are
applicable to electronic products as specified herein, to control
electronic product radiation from such products. Standards so
prescribed are subject to amendment or revocation and additional
standards may be prescribed as are determined necessary for the
protection of the public health and safety.
0
31. In Sec. 1010.4, paragraph (a)(1) is revised to read as follows:
Sec. 1010.4 Variances.
(a) Criteria for variances. (1) Upon application by a manufacturer
(including an assembler), the Director, Center for Devices and
Radiological Health, Food and Drug Administration, may grant a variance
from one or more provisions of any performance standard under
subchapter J of this chapter for an electronic product subject to such
standard when the Director determines that granting such a variance is
in keeping with the purposes of Subchapter C--Electronic Product
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly
the Radiation Control for Health and Safety Act of 1968), and:
(i) The scope of the requested variance is so limited in its
applicability as not to justify an amendment to the standard, or
(ii) There is not sufficient time for the promulgation of an
amendment to the standard.
* * * * *
Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13915 Filed 6-18-08; 8:45 am]
BILLING CODE 4160-01-S