Document ID: FDA-2013-N-1529-0019
Agency: fda
Document Type: Rule
Title: Medical Device Classification Procedures; Change of Address; Technical Amendment
Posted Date: 2017-08-21T04:00Z

[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Rules and Regulations]
[Pages 39534-39535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17564]

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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; Change of Address; 
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 Classification Procedures regulation to reflect a 
change in address for the Center for Devices and Radiological Health 
(CDRH). This action is editorial in nature and is intended to improve 
the accuracy of the Agency's regulations.

DATES: This rule is effective August 21, 2017.

FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993-0002, 301-796-9603.

[[Page 39535]]

SUPPLEMENTARY INFORMATION: FDA is amending our regulations in 21 CFR 
part 860 that set forth procedures for mailing reclassification 
petitions (Sec.  860.123 (21 CFR 860.123)) to revise the mailing 
address for CDRH. The current mailing address in the regulation for 
CDRH is as follows: Center for Devices and Radiological Health, 
Regulations Staff, 10903 New Hampshire Ave., Bldg. 66, Rm. 4438, Silver 
Spring, MD 20993-0002. The room number, 4438, has been changed; the new 
room number is G609. The mailing address is revised as follows: Center 
for Devices and Radiological Health, Regulations Staff, Document Mail 
Center-WO66-G609, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002.
    Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(e) and (f); 
360d(b); 360e(b), and 360j(l)), provide for the reclassification of a 
device and prescribe procedures to petition for reclassification. FDA 
provides procedures for the content and form of reclassification 
petitions submitted pursuant to Sec.  860.123(b)(1) for devices 
regulated by CDRH. The address for submitting a reclassification 
petition for devices regulated by CDRH in Sec.  860.123(b)(1) is 
amended to reflect the new room number. The addresses remain the same 
for the Center for Biologics Evaluation and Research and the Center for 
Drug Evaluation and Research.

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 
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 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, Document 
Mail Center-WO66-G609, 10903 New Hampshire Ave., 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: August 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17564 Filed 8-18-17; 8:45 am]
 BILLING CODE 4164-01-P