Document ID: FDA-2013-N-0011-0002
Agency: fda
Document Type: Rule
Title: Medical Devices; Technical Amendments
Posted Date: 2013-03-26T04:00Z

[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Rules and Regulations]
[Pages 18233-18234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06826]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 
880, 882, 884, 886, 888, 890, and 892

[Docket No. FDA-2013-N-0011]

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 minor errors in the Code of 
Federal Regulations (CFR). This action is editorial in nature and is 
intended to provide accuracy and clarity to the Agency's regulations.

DATES: This rule is effective March 26, 2013.

FOR FURTHER INFORMATION CONTACT: Abigail Corbin, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave. Bldg. 66, rm. 4430, Silver Spring, MD 20993-0002, 301-796-9142.

SUPPLEMENTARY INFORMATION: FDA is amending certain regulations in 21 
CFR parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 
882, 884, 886, 888, 890, and 892. This action corrects minor spelling 
errors and outdated Web site addresses affecting certain regulations 
regarding medical devices.
    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). These 
amendments are merely correcting nonsubstantive errors. 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.
    FDA 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. In 
addition, FDA has determined that this final rule contains no 
collection 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 Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 862

    Medical devices.

21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 868, 870, 872, 874, 876, 878, and 880

    Medical devices.

21 CFR Part 882

    Medical devices, Neurological devices.

21 CFR Part 884

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 888

    Medical devices.

21 CFR Part 890

    Medical devices, Physical medicine 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 
Chapter I is amended as follows:

Sec. Sec.  814.20, 822.7, 822.15, 862.1, 864.1, 866.1, 868.1, 870.1, 
872.1, 874.1, 876.1, 878.1, 880.1, 882.1, 884.1, 886.1, 888.1, 890.1, 
and 892.1  [Amended]

    1. In the table below, for each section indicated in the left 
column, remove the Web address indicated in the middle column from 
wherever it appears in the section, and add the Web address indicated 
in the right column:

------------------------------------------------------------------------
             Section                    Remove                Add
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814.20..........................  http://www.fda.gov/ http://www.fda.gov/
                                   cdrh/devadvice/     MedicalDevices/
                                   pma/.               DeviceRegulationa
                                                       ndGuidance/
                                                       HowtoMarketYourDe
                                                       vice/
                                                       PremarketSubmissi
                                                       ons/
                                                       PremarketApproval
                                                       PMA/default.htm.
822.7...........................  http://www.fda.gov/ http://www.fda.gov/
                                   cdrh/ombudsman/     AboutFDA/
                                   dispute.html.       CentersOffices/
                                                       OfficeofMedicalPr
                                                       oductsandTobacco/
                                                       CDRH/
                                                       CDRHOmbudsman/
                                                       default.htm.
822.15..........................  www.fda.gov/cdrh/   http://www.fda.gov/
                                   ombudsman/.         AboutFDA/
                                                       CentersOffices/
                                                       OfficeofMedicalPr
                                                       oductsandTobacco/
                                                       CDRH/
                                                       CDRHOmbudsman/
                                                       default.htm.
862.1, 864.1, 866.1, 868.1,       http://www.fda.gov/ http://www.fda.gov/
 870.1, 872.1, 874.1, 876.1,       cdrh/               MedicalDevices/
 878.1, 880.1, 882.1, 884.1,       guidance.html.      DeviceRegulationa
 886.1, 888.1, 890.1, and 892.1.                       ndGuidance/
                                                       GuidanceDocuments/
                                                       default.htm.
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[[Page 18234]]

PART 870--CARDIOVASCULAR DEVICES

0
2. The authority citation for 21 CFR part 870 continues to read as 
follows:

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

0
3. Amend Sec.  870.3600 by revising the second sentence in paragraph 
(a) to read as follows:

Sec.  870.3600  External pacemaker pulse generator.

    (a) Identification. * * * This device, which is used outside the 
body, is used as a temporary substitute for the heart's intrinsic 
pacing system until a permanent pacemaker can be implanted, or to 
control irregular heartbeats in patients following cardiac surgery or a 
myocardial infarction. * * *
* * * * *
0
4. Amend Sec.  870.5300 by revising the section heading to read as 
follows:

Sec.  870.5300  DC-defibrillator (including paddles).

* * * * *

PART 882--NEUROLOGICAL DEVICES

0
5. 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
6. Amend Sec.  882.5870 by revising the second sentence in paragraph 
(a) to read as follows:

Sec.  882.5870  Implanted peripheral nerve stimulator for pain relief.

    (a) Identification. * * * The stimulator consists of an implanted 
receiver with electrodes that are placed around a peripheral nerve and 
an external transmitter for transmitting the stimulating pulses across 
the patient's skin to the implanted receiver.
* * * * *

PART 886--OPHTHALMIC DEVICES

0
7. 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
8. Amend Sec.  886.1120 by revising the section heading to read as 
follows:

Sec.  886.1120  Ophthalmic camera.

* * * * *

    Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06826 Filed 3-25-13; 8:45 am]
BILLING CODE 4160-01-P