Medical Devices; Technical Amendment, 34857-34861 [E8-13915]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 119 (Thursday, June 19, 2008)]
[Rules and Regulations]
[Pages 34857-34861]
From the Federal Register Online via the Government Printing 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 https://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 https://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 https://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 https://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