Document ID: FDA-2019-N-1345-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Technical Amendment
Posted Date: 2019-04-01T04:00Z

[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Rules and Regulations]
[Page 12083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06139]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 806

[Docket No. FDA-2019-N-1345]

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 or Agency) is amending 
the medical device reports of corrections and removals regulation to 
correct three inaccurate cross-references. This action is editorial in 
nature and is intended to improve the accuracy of the Agency's 
regulations.

DATES: This rule is effective April 1, 2019.

FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Office of the 
Center Director, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5518, 
Silver Spring, MD 20993-0002, 301-796-5837.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 806.1 to correct 
three inaccurate cross-references to ensure accuracy and clarity in the 
Agency's medical device regulations regarding medical device reports of 
corrections and removals. Publication of this document constitutes 
final action under the Administrative Procedure Act (5 U.S.C. 553). FDA 
has determined that notice and public comment are unnecessary because 
this amendment to the regulation is nonsubstantive and provides only 
technical changes to correct inaccurate cross-references.
    In the Federal Register of September 24, 2013 (78 FR 58821), FDA 
added the definition of ``Human cells, tissues, or cellular or tissue-
based product (HCT/P) regulated as a device'' at Sec.  806.2(f). The 
addition of this definition caused the paragraphs following paragraph 
(f) in Sec.  806.2 to be redesignated alphabetically. Although the 
definitions of the terms were correct in Sec.  806.2, the paragraphs in 
Sec.  806.1(b) cross-referenced three of the definitions (market 
withdrawal, routine servicing, and stock recovery) from Sec.  806.2 
based on the previous designations.

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 part 806 continues to read as follows:

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

0
2. In Sec.  806.1, revise paragraphs (b)(2) through (4) to read as 
follows:

Sec.  806.1   Scope.

* * * * *
    (b) * * *
    (2) Market withdrawal as defined in Sec.  806.2(i)
    (3) Routine servicing as defined in Sec.  806.2(l).
    (4) Stock recovery as defined in Sec.  806.2(m).

    Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06139 Filed 3-29-19; 8:45 am]
 BILLING CODE 4164-01-P