Medical Devices; Technical Amendment
Federal Register, Volume 78 Issue 58 (Tuesday, March 26, 2013)
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 This action corrects minor spelling errors and outdated Web site addresses affecting certain regulations regarding medical devices.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
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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:
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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
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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
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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
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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
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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
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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
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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
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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
