2014-20107. Medical Devices; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

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 This action is editorial in nature and is intended to correct outdated Web site addresses.

DATES:

This rule is effective August 25, 2014.

FOR FURTHER INFORMATION CONTACT:

Aaron Josephson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993-0002, 301-796-5178.

SUPPLEMENTARY INFORMATION:

FDA is amending certain regulations in parts 862, 864, 866, and 872 (21 CFR parts 862, 864, 866, and 872). This action updates certain Web site addresses that have been changed due to recent FDA Web site changes.

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 862

• Medical devices

21 CFR Part 864

• Blood
• Medical devices
• Packaging and containers

21 CFR Part 866

• Biologics
• Laboratories
• Medical devices

21 CFR Part 872

• Medical devices

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:

PARTS 862, 864, 866, AND 872 [AMENDED]

1. The authority citation for parts 862, 864, 866, and 872 continues to read as follows:

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

§§ 862.1, 864.1, 866.1, and 872.1

[Amended]

2. In the following table, for each section indicated in the left column, remove the Web site address indicated in the middle column from wherever the Web site address appears in the section, and add the Web site address indicated in the right column:

Section	Remove	Add
862.1	http://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofMedicalProductsandTobacco/​CDRH/​CDRHOmbudsman/​default.htm	http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm.
864.1	http://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofMedicalProductsandTobacco/​CDRH/​CDRHOmbudsman/​default.htm	http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm.
866.1	http://www.fda.gov/​cdrh.guidance.html	http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm.
872.1	http://www.fda.gov/​cdrh.guidance.html	http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm.

Dated: August 19, 2014.

Peter Lurie,

Associate Commissioner for Policy and Planning.