Document ID: FDA-2014-N-0011-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Reports of Corrections and Removals; Technical
Amendment
Posted Date: 2014-02-19T05:00Z

[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Rules and Regulations]
[Page 9413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03581]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 806

[Docket No. FDA-2014-N-0011]

Medical Devices; Reports of Corrections and Removals; 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 its 
regulation regarding reports of corrections to and removals of medical 
devices to address a minor change as a result of the enactment of the 
Food and Drug Administration Amendments Act of 2007 (FDAAA). This 
action is technical in nature and is intended to provide accuracy to 
the Agency's regulation.

DATES: This rule is effective February 19, 2014.

FOR FURTHER INFORMATION CONTACT: Deborah Yoder, Office of Compliance, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2676, Silver 
Spring, MD 20993-0002, 301-796-6109, Deborah.Yoder@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 806.1(a) (21 CFR 806.1(a)) refers to 
a subsection of the Federal Food, Drug, and Cosmetic Act that was 
redesignated as a result of FDAAA (Pub. L. 110-85). FDA is amending 
Sec.  806.1(a) to update the obsolete reference.
    FDA is publishing the document as a final rule under the 
Administrative Procedures Act (5 U.S.C. 551, et seq.). FDA has 
determined that good cause exists to dispense with prior notice and 
public comment under 5 U.S.C. 553(b)(3)(B) and 21 CFR 10.40(e)(1) since 
such notice and comment are unnecessary because this amendment to the 
regulation provides only a technical change to update an obsolete 
citation. In addition, FDA finds good cause to provide for this 
regulation to be effective immediately upon publication under 5 U.S.C. 
553(d)(3).
    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.
    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 806 have been approved under 
OMB control number 0910-0359, which expires May 31, 2014.

List of Subjects in 21 CFR Part 806

    Imports, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
806 is amended as follows:

PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

0
1. The authority citation for 21 CFR part 806 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

Sec.  806.1  [Amended]

0
2. Amend Sec.  806.1(a) by removing ``section 519(f)'' and adding in 
its place ``section 519(g)''.

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03581 Filed 2-18-14; 8:45 am]
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