Document ID: FDA-2013-N-1529-0018
Agency: fda
Document Type: Rule
Title: Medical Device Classification Procedures: Reclassification Petition: Content and Form; Technical Amendment
Posted Date: 2014-12-24T05:00Z

[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Rules and Regulations]
[Pages 77387-77388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30141]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 860

[Docket No. FDA-2013-N-1529]

Medical Device Classification Procedures; Reclassification 
Petition: Content and Form; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations for petitioning for device reclassification to update 
mailing addresses for the petitions. This action is being taken to 
improve the accuracy of the regulations.

DATES: This rule is effective December 24, 2014.

FOR FURTHER INFORMATION CONTACT: Nancy Pirt, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4438, Silver Spring, MD 20993-0002, 301-796-6254.

SUPPLEMENTARY INFORMATION: FDA is updating mailing addresses for device 
reclassification petitions (21 CFR 860.123). For devices regulated by 
the Center for Devices and Radiological Health, the room number is now 
4438. In addition, the Center for Biologics Evaluation and Research has 
moved to a new location at FDA's White Oak Campus. The address remains 
the same for the Center for Drug Evaluation and Research. The 
regulations are being amended to ensure clarity and to improve the 
accuracy and readability of the regulations.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment and a delayed effective date 
are unnecessary because these corrections are nonsubstantive.

List of Subjects in 21 CFR Part 860

    Administrative practice and procedure, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

[[Page 77388]]

authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
860 is amended as follows:

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
1. The authority citation for 21 CFR part 860 continues to read as 
follows:

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

0
2. Revise Sec.  860.123(b)(1) to read as follows:

Sec.  860.123  Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (1) For devices regulated by the Center for Devices and 
Radiological Health, addressed to the Food and Drug Administration, 
Center for Devices and Radiological Health, Regulations Staff, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4438, Silver Spring, MD 20993-0002; 
for devices regulated by the Center for Biologics Evaluation and 
Research, addressed to the Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Center, 10903 New 
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for 
devices regulated by the Center for Drug Evaluation and Research, 
addressed to the Food and Drug Administration, Center for Drug 
Evaluation and Research, Central Document Control Room, 5901-B 
Ammendale Rd., Beltsville, MD 20705-1266, as applicable.
* * * * *

    Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30141 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P