
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Rules and Regulations]
[Pages 11428-11429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04707]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 801 and 830

[Docket No. FDA-2011-N-0090]


Unique Device Identification System; Editorial Provisions; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
the Unique Device Identification (UDI) System regulation to make 
editorial changes. This technical amendment updates the email address 
associated with FDA's UDI system, which allows FDA to obtain 
information and offer support and assistance on medical devices through 
their distribution and use, ensuring consistency with the requirements 
in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This change 
is necessary to ensure that the UDI team continues to maintain regular 
email communications with device labelers.

DATES: This rule is effective March 4, 2016.

FOR FURTHER INFORMATION CONTACT: Adaeze Teme, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5574, Silver Spring, MD 20993-0002, 240-402-0768.

SUPPLEMENTARY INFORMATION: FDA is updating the UDI email address in the 
following regulations that set forth the procedures for notifying the 
Agency when: (1) Requesting an exception from or alternative to a 
unique device identifier requirement (Sec.  801.55 (21 CFR 801.55)); 
(2) requesting continued use of legacy FDA identification numbers 
assigned to devices (Sec.  801.57 (21 CFR 801.57)); and (3) applying 
for accreditation as an issuing Agency (Sec.  830.110 (21 CFR 
830.110)).
    Specifically, the Agency is removing an old email address and 
replacing it with a new one, thereby maintaining consistency with the 
requirements of the FD&C Act (21 U.S.C. 321 et seq.).
    In the Federal Register of September 24, 2013 (78 FR 58786), FDA 
issued a final rule to establish a system to adequately identify 
devices through distribution and use. The rule required the label of 
medical devices to include a UDI, except where an exception or 
alternative applies. The labeler must submit product information 
concerning devices to FDA's Global Unique Device Identification 
Database (GUDID). The final rule incorporated a direct avenue for the 
labeler to communicate with FDA's GUDID via a UDI email address. This 
rule updates Sec. Sec.  801.55(b)(2), 801.57(c)(2), and 830.110(a) by 
replacing the old email address with a new one.

List of Subjects

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 830

    Administrative practice and procedure, Incorporation by reference, 
Labeling, 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 parts 
801and 830 are amended as follows:

PART 801--LABELING

0
1. The authority citation for 21 CFR part 801 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.


0
2. In Sec.  801.55, revise paragraph (b)(2) to read as follows:


Sec.  801.55  Request for an exception from or alternative to a unique 
device identifier requirement.

* * * * *
    (b) * * *
    (2) In all other cases, by email to: GUDIDSupport@fda.hhs.gov, or 
by correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
* * * * *

0
3. In Sec.  801.57, revise the second sentence of paragraph (c)(2) to 
read as follows:


Sec.  801.57  Discontinuation of legacy FDA identification numbers 
assigned to devices.

* * * * *
    (c) * * *
    (2) * * * * A request for continued use of an assigned labeler code 
must be submitted by email to: GUDIDSupport@fda.hhs.gov, or by 
correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
* * * * *

[[Page 11429]]

PART 830--UNIQUE DEVICE IDENTIFICATION

0
4. The authority citation for 21 CFR part 830 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 
371.

0
5. In Sec.  830.110, revise paragraph (a)(1) to read as follows:


Sec.  830.110  Application for accreditation as an issuing agency.

    (a) * * * (1) An applicant seeking initial FDA accreditation as an 
issuing agency shall notify FDA of its desire to be accredited by 
sending a notification by email to: GUDIDSupport@fda.hhs.gov, or by 
correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
* * * * *

    Dated: February 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04707 Filed 3-3-16; 8:45 am]
 BILLING CODE 4164-01-P


