[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Proposed Rules]
[Pages 69393-69399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. FDA-2011-N-0090]
RIN 0910-AG31


Unique Device Identification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its July 
10, 2012, proposed rule (77 FR 40736) to establish a unique device 
identification system as required by recent amendments to the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food 
and Drug Administration Safety and Innovation Act (FDASIA) was signed 
into law; section 614 of FDASIA amends the FD&C Act in ways that 
require modification of the timeframe for implementation of the 
proposed rule's requirements as they apply to devices that are 
implantable, life-saving (life-supporting), or life-sustaining.

DATES: Submit either electronic or written comments on the amendment to 
the Proposed Rule by December 19, 2012. See section VII for the 
proposed effective dates of a final rule based on the amended proposed 
rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0090 and/or RIN Number 0910-AG31, by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (For paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket Number, and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jay Crowley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-5995, email: 
cdrhudi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, FDASIA was signed into law (Pub. L. 112-144). On 
July 10, 2012, FDA published a proposed rule to establish a unique 
device identification system, as required by section 519(f) of the FD&C 
Act (21 U.S.C. 360i(f)). Section 614 of FDASIA amends section 519(f) of 
the FD&C Act in ways that require modification of the timeframe for 
implementation of the proposed rule's requirements as they apply to 
devices that are implantable, life-saving (life-supporting), or life-
sustaining. This document explains how FDA is amending the July 10, 
2012, proposed rule to meet the requirements of amended section 519(f) 
of the FD&C Act.

II. Description of the Proposed Rule

A. FDA's July 10, 2012, Proposed Rule

    Our July 10, 2012, document provides a detailed description of the 
proposed rule. The proposed rule includes unique device identifier 
(UDI) labeling requirements (proposed for inclusion in 21 CFR part 
801), requirements relating to issuing Agencies and submission of data 
to the Global Unique Device Identification Database (GUDID) (proposed 
new part 830), and conforming amendments to several existing FDA 
regulations. FDA proposed a phased implementation of the rule's 
requirements, with some requirements going into effect immediately 
after publication of a final rule, and other requirements going into 
effect 1 year, 3 years, 5 years, and 7 years after publication of a 
final rule. This phased implementation is summarized in the July 10, 
2012, proposed rule by Table 7--Effective Dates of UDI Regulatory 
Requirements (77 FR 40736 at 40764).

B. Changes Required by the Enactment of FDASIA

    Section 614 of FDASIA amends section 519(f) of the FD&C Act, the 
provision that requires FDA to establish a unique device identification 
system. Prior to the enactment of FDASIA, section 519(f) of the FD&C 
Act did not specify the date by which a proposed rule is required, did 
not identify any particular devices as requiring expedited 
implementation of UDI requirements, and did not specify timeframes for 
publication of a final rule. The FDASIA amendments to section 519(f) 
address each of those points. As amended by FDASIA, section

[[Page 69394]]

519(f) of the FD&C Act now requires that not later than December 31, 
2012, the Secretary shall issue proposed regulations establishing a 
unique device identification system for medical devices requiring the 
label of devices to bear a unique identifier, unless the Secretary 
requires an alternative placement or provides an exception for a 
particular device or type of device. The unique identifier shall 
adequately identify the device through distribution and use, and may 
include information on the lot or serial number. Section 519(f) of the 
FD&C Act also requires that the Secretary shall finalize the proposed 
regulations not later than 6 months after the close of the comment 
period and shall implement the final regulations with respect to 
devices that are implantable, life-saving, and life sustaining not 
later than 2 years after the regulations are finalized, taking into 
account patient access to medical devices and therapies.
    The change that has prompted amendment of FDA's proposed rule is 
the provision in the final sentence that requires ``final regulations 
with respect to devices that are implantable, life-saving, and life 
sustaining'' to be implemented within 2 years of finalization of the 
rule. (We refer to ``life-saving'' devices as ``life-supporting,'' as 
explained later in this document.). Thus we are amending our July 10, 
2012, proposed rule by changing some of the proposed effective dates 
for requirements applicable to implantable, life-supporting, and life-
sustaining devices, so that the requirements applicable to these 
devices will be effective no later than 2 years from finalization of 
the rule.
    Under our July 10, 2012, proposed rule, all class III devices and 
all devices licensed under the Public Health Service Act (PHS Act) (42 
U.S.C. 262) would be required to bear a UDI within 1 year of the date 
we publish a final rule; thus, this effective date does not need to be 
changed. Pursuant to amended section 519(f) of the FD&C Act, we are now 
proposing to require all other implantable, life-supporting, and life-
sustaining devices (i.e., those that are not already subject to the 1-
year effective date) to bear a UDI within 2 years following the 
publication of a final rule. (See proposed Sec.  801.20(b)(2) as 
amended by this document.) Under our July 10, 2012, proposed rule, when 
a device is required to be labeled with a UDI, proposed Sec.  830.300 
would require the labeler of that device to submit information 
concerning the device to the GUDID. Consequently, the labelers of all 
implantable, life-supporting, and life-sustaining devices will be 
required to submit data to the GUDID within 2 years of the date we 
publish a final rule; see proposed Sec.  801.20(b)(1) and (b)(2) as 
amended by this document.
    Proposed Sec.  801.50 would require direct marking of the UDI on 
the device itself for implantable devices, devices intended to be used 
more than once and that are intended to be sterilized before each use, 
and stand-alone software. We are now amending the proposed rule so that 
any such devices that fall into the categories specified by revised 
section 519(f) of the FD&C Act--devices that are implantable, life 
supporting, or life sustaining--would have to comply with Sec.  801.50, 
establishing a system of unique device identification 2 years after 
publication of a final rule. FDA believes that the only devices subject 
to direct marking that fit within the device categories expressly 
referred to in revised section 519(f) of the FD&C Act are implantable 
devices and is assuming only implantable devices will be affected by 
the revised implementation date for the direct marking requirement. We 
welcome comments on whether any devices subject to the direct marking 
requirement under proposed Sec.  801.50 other than implantable devices 
fit within the device categories in amended section 519(f) of the FD&C 
Act.
    FDA interprets ``life-saving'' in section 519(f) of the FD&C Act, 
as amended by section 614 of FDASIA, to have the same meaning as 
``life-supporting'' in other device provisions of the FD&C Act. Section 
614 of FDASIA refers to devices that are ``implantable, life-saving, 
and life-sustaining.'' The device provisions of the FD&C Act do not use 
the term ``life-saving'' in any other instance, but in several 
instances refer to devices that are ``implantable, life sustaining, or 
life supporting.'' (See section 513(a) of the FD&C Act (21 U.S.C. 
360c(a)) (definitions of class II and class III devices); section 519 
(records and reports on devices, including adverse event reporting and 
device tracking); section 522 of the FD&C Act (21 U.S.C. 360l) 
(postmarket surveillance); and section 523 of the FD&C Act (21 U.S.C. 
360m) (accredited persons).) In order for the language of our proposed 
UDI rule to be consistent with existing FDA regulations and the other 
provisions of the FD&C Act, in the amendments to the proposed 
regulations we use the term ``life-supporting'' instead of ``life-
saving.'' FDA, the medical device industry, and the health care 
community are already familiar with the term ``life-supporting'' as 
applied to medical devices, which will facilitate FDA's implementation 
of the amended proposed rule.
    A list of product codes for devices that FDA considers to be 
implantable, life-saving, and life-sustaining for purposes of section 
614 of FDASIA, amending section 519(f) of the FD&C Act, is available in 
docket FDA-2011-N-0090 (Ref. 12).
    FDA is not extending the comment period of the proposed rule, which 
closed on November 7, 2012. We do not believe that amending some of the 
proposed effective dates for certain categories of devices necessitates 
additional time to review the amended proposed rule and to submit 
comments to FDA.

C. How the Amendments Made by This Proposed Rule Will Affect the July 
10, 2012, Proposed Rule

    These amendments affect only implantable, life-supporting, or life-
sustaining devices. With the exception of the change to the proposed 
effective date for the direct marking requirement, these amendments do 
not affect class III devices or devices licensed under the PHS Act 
because such devices would have to bear a UDI within 1 year of 
finalization under the July 10, 2012, proposed rule.
    We are updating Table 7--Effective Dates of UDI Regulatory 
Requirements, of the July 10, 2012, proposed rule to reflect the 
revisions provided by this document; we have also corrected two 
citations within the table (citations to Sec.  830.320 should have 
cited Sec.  830.300). Updated table 7 appears in this document in 
section VI. Updated Proposed Effective Dates.
    New table 8 of this document summarizes the effects of the 
amendments we are making to the July 10, 2012, proposed rule.

 Table 8--Effects of the Amendments to the July 10, 2012, Proposed Rule
------------------------------------------------------------------------
                                             Effect of amendments to
           Category of device                     proposed rule
------------------------------------------------------------------------
Class III implantable, life-supporting,  No effect with respect to
 and life-sustaining devices, and         proposed requirement for
 implantable, life-supporting, and life-  device to bear UDI on the
 sustaining devices licensed under the    label and device package or
 PHS Act.                                 proposed requirements for
                                          submission of data to the
                                          GUDID.

[[Page 69395]]

 
                                         Implantable devices would have
                                          to bear a UDI as a permanent
                                          marking on the device itself 1
                                          year earlier than first
                                          proposed.
Class II implantable, life-supporting,   Would have to bear a UDI on the
 and life-sustaining devices.             label and device package and
                                          submit data to the GUDID 1
                                          year earlier than first
                                          proposed.
                                         Implantable devices would have
                                          to bear a UDI as a permanent
                                          marking on the device itself 3
                                          years earlier than first
                                          proposed.
Class I implantable, life-supporting,    Would have to bear a UDI on the
 and life-sustaining devices, and         label and device package and
 implantable, life-supporting, and life-  submit data to the GUDID 3
 sustaining devices that have not been    years earlier than first
 classified into class I, II, or III.     proposed.
                                         Implantable devices would have
                                          to bear a UDI as a permanent
                                          marking on the device itself 5
                                          years earlier than first
                                          proposed.
------------------------------------------------------------------------

D. Request for Comments

    This amendment announces changes to the proposed rule required by 
FDASIA. The comment period on the proposed rule closed on November 7, 
2012. We request comments only on the changes discussed in this 
amendment to the proposed rule and may decline to consider other 
comments submitted to this docket.

III. Legal Authority for the Proposed Rule

    Section 226 of the Food and Drug Administration Amendments Act 
(Pub. L. 110-85) (2007), amended the FD&C Act by adding a new section 
519(f). This section provides for FDA to issue regulations establishing 
a unique device identification system for medical devices. In addition, 
section 510(e) of the FD&C Act (21 U.S.C. 360(e)) authorizes FDA to 
issue regulations to ``prescribe a uniform system for identification of 
devices'' and to require persons to ``list such devices in accordance 
with such system.'' Therefore, FDA is issuing the provisions of this 
proposed rule that would establish a unique device identification 
system under sections 510(e), 519(f), and 701(a) (21 U.S.C. 371(a)) of 
the FD&C Act (which provides FDA the authority to issue regulations for 
the efficient enforcement of the FD&C Act).
    Devices for which there has been a failure or refusal to furnish 
any material or information required by or under section 519 of the 
FD&C Act respecting the device are misbranded under section 502(t)(2) 
of the FD&C Act (21 U.S.C. 352(t)(2)). The failure or refusal to 
furnish any material or information required by or under section 519 of 
the FD&C Act is a prohibited act under section 301(q)(1)(B) of the FD&C 
Act (21 U.S.C. 331(q)(1)(B)).
    Section 701(a) of the FD&C Act gives FDA the authority to issue 
regulations for the efficient enforcement of the FD&C Act. By requiring 
a UDI to appear on the label of devices, and by establishing the GUDID, 
the proposed rule is designed to improve the accuracy and precision of 
adverse event reporting, as required by section 519(a) and (b) of the 
FD&C Act, which will enable FDA to more quickly and precisely identify 
device problems, such as safety and/or effectiveness concerns. Once a 
problem is identified, whether through improved reporting or otherwise, 
the presence of the UDI on the device label, packaging, in certain 
cases directly marked on the device itself, and in the GUDID will 
enable FDA to more efficiently and effectively respond, and protect the 
public health by addressing the problem using one or more of the 
regulatory tools that Congress has provided for this purpose, such as 
notification or mandatory recall under section 518 of the FD&C Act (21 
U.S.C. 360h), tracking under section 519(e) of the FD&C Act, ensuring 
the adequacy of a voluntary recall with the assistance of reports of 
corrections and removals as required by section 519(g) of the FD&C Act, 
or seizing a device that is adulterated under section 501 of the FD&C 
Act (21 U.S.C. 351) and/or misbranded under section 502 of the FD&C 
Act. Thus, these provisions of the proposed rule are issued under the 
authority of these sections in addition to the broad authority of 
section 519(f) of the FD&C Act.
    Section 510(j) of the FD&C Act requires listing information to be 
accompanied by, at minimum, the label, package insert, and a 
representative sampling of any other labeling for the device (see 
section 510(j)(1)(B)(ii)). For certain categories of devices, all 
labeling must be submitted (see section 510(j)(1)(A) and (j)(1)(B)(i) 
of the FD&C Act). We expect most of the information that would be 
required to be submitted to the GUDID (see proposed Sec.  830.310), is 
information that appears on the device label or in the package insert, 
and is included in the information that is required to be submitted to 
FDA by section 510(j) of the FD&C Act.
    The provisions of the proposed rule that would require UDIs to be 
included in various records and reports, allow the use of UDIs to 
identify devices subject to reports of corrections and removals and 
records of corrections of removals that are not required to be reported 
to FDA, and require reporting of UDIs in periodic reports for class III 
devices, are issued under the authority of sections 519 and 701(a) of 
the FD&C Act.
    The provisions of the proposed rule that would amend the Quality 
System Regulation by requiring examination of the accuracy of the UDI 
as part of the scope of the labeling inspection, that the device 
history record include any UDI or universal product code (UPC), that 
complaint records include any UDI or UPC, and that the service report 
include an UDI or UPC, are issued under sections 520(f) (21 U.S.C. 
360j(f)) and 701(a) of the FD&C Act.
    The provisions of the proposed rule that would require the 
inclusion of UDIs on reports regarding tracked devices is authorized by 
sections 519(e) and 701(a) of the FD&C Act.
    The provision of the proposed rule that would require that 
postmarket surveillance plans submitted to FDA include the device 
identifier of the devices involved is issued under sections 522 (21 
U.S.C. 360l), and 701(a) of the FD&C Act.
    Finally, the changes in proposed effective dates for devices that 
are implantable, life-saving, and life sustaining, are pursuant to the 
changes to section 519(f) of the FD&C Act made by section 614 of 
FDASIA.

IV. Analysis of Impacts

    Our July 10, 2012, document summarizes the analysis of impacts of 
the proposed rule. The full analysis of impacts and findings that are 
presented in Preliminary Regulatory Impact Analysis (RIA) of the 
proposed rule remain unchanged (Ref. 10 of the July 10, 2012, proposed 
rule). However, we are amending our summary of costs to include the 
FDASIA requirement to

[[Page 69396]]

incorporate the revised implementation date of 2 years for devices that 
are implantable, life-supporting, and life-sustaining. The July 10, 
2012, RIA and the Addendum to the RIA (new Ref. 13) are available at 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htm.
    We lack sufficient information to estimate the number of 
establishments that label life-supporting and life-sustaining devices 
and would be affected by the FDASIA requirement. Therefore, for this 
amended cost summary, we make a simplifying assumption that labelers of 
all class II devices would comply with the UDI requirements in year 2 
instead of year 3 as initially specified under the proposed rule. 
Because the modified timeframe would advance the implementation date to 
directly mark implantable, life-supporting, and life-sustaining 
devices, we assume that labelers of class III devices that are implants 
would comply with the direct marking requirements in year 2 instead of 
year 3 as initially specified under the proposed rule. The effect of 
these simplifying assumptions might be to overstate the annualized 
costs for some labelers of class II devices that are not considered 
life-supporting or life-sustaining devices, and to underestimate the 
annualized costs for some labelers of class I devices that are 
considered life-supporting or life-sustaining devices.
    The amended summary of the total costs of the proposed rule for all 
sectors is presented in the updated table 3 of this document. The total 
present value of domestic costs for all affected sectors would be about 
$554.8 million over 10 years with a 7 percent discount rate and $625.4 
million at 3 percent. The total annualized costs over 10 years would be 
$73.8 million at 7 percent and $71.1 million at 3 percent. The total 
increase in annualized costs to domestic labelers compared to the 
proposed rule is about $5.4 million at 7 percent over 10 years.

                 Updated Table 3--Summary of the Estimated Regulatory Costs of the Proposed Rule
                                               [2010 dollars] 1 2
----------------------------------------------------------------------------------------------------------------
                                     Total present value of cost over 10    Total annualized costs over 10 years
                                             years  ($ million)                         ($ million)
         Affected sectors         ------------------------------------------------------------------------------
                                        3 Percent           7 Percent           3 Percent          7 Percent
----------------------------------------------------------------------------------------------------------------
Domestic Labelers................  $608.3............  $540.2............  $69.2.............  $71.9.
Issuing Agencies.................  $1.0..............  $0.9..............  $0.1..............  $0.1.
FDA..............................  $16.1.............  $13.7.............  $1.8..............  $1.8.
Imports..........................  Not quantified....  Not quantified....  Not quantified....  Not quantified.
                                  ------------------------------------------------------------------------------
    Total Domestic Cost of the     $625.4............  $554.8............  $71.1.............  $73.8.
     Proposed Rule.
----------------------------------------------------------------------------------------------------------------
\1\ Present value and annualized costs calculated at the beginning of the period.
\2\ Domestic costs for labelers are revised to reflect FDASIA requirement that labelers of affected devices
  comply in year 2. However, FDA's revised estimate assumes that all class II devices would comply in year 2.

    Updated table 1 (and identical updated table 4 of the proposed 
rule) presents the Regulatory Information Service Center (RISC) and 
Office of Information and Regulatory Affairs (OIRA) Combined 
Information System (ROCIS) accounting information under the assumption 
that labelers of all class II devices would comply with the UDI 
requirements in year 2 and that all labelers of class II implantable 
devices would comply with the direct marking requirements in year 2.

[[Page 69397]]

[GRAPHIC] [TIFF OMITTED] TP19NO12.001

V. Information Collection Requirements

    The updates made by this proposed rule do not affect the estimate 
we previously provided regarding our July 10, 2012, proposed rule.
    In accordance with section 3507(d) of the PRA (44 U.S.C. 3501 et 
seq.), the information collection or recordkeeping requirements 
included in this proposed rule have been submitted for approval to OMB. 
A copy of the supporting statement for this information collection is 
available on the Internet at http://www.reginfo.gov/public/do/PRAMain 
(OMB Number 0910-0720) and is posted to the docket at http://www.regulations.gov, in docket FDA-2011-N-0090 (Ref. 11 of the proposed 
rule).

VI. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action 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.

VII. Updated Proposed Effective Dates

    FDA updates Table 7--Effective Dates of UDI Regulatory 
Requirements, in our July 10, 2012, proposed rule as follows.

[[Page 69398]]



                         Updated Table 7--Effective Dates of UDI Regulatory Requirements
----------------------------------------------------------------------------------------------------------------
                 Effective date                                            Requirement
----------------------------------------------------------------------------------------------------------------
Immediately upon publication of a final rule...  Requests for an exception or alternative to UDI labeling
                                                  requirements may be submitted pursuant to Sec.   801.35.
                                                 Sec.  Sec.   830.100-830.130 (subpart C of part 830, concerning
                                                  accreditation of issuing Agencies) and Sec.   830.10
                                                  (incorporation by reference of certain standards) go into
                                                  effect. This will allow applications for accreditation as an
                                                  issuing Agency to be submitted to FDA immediately.
One year after publication of a final rule.....  Dates on medical device labels must be formatted as required by
                                                  Sec.   801.18.
                                                 The label and package of class III medical devices and devices
                                                  licensed under the PHS Act must bear a UDI. Sec.
                                                  801.20(b)(1).
                                                 Data for class III devices and devices licensed under the PHS
                                                  Act that are required to be labeled with a UDI must be
                                                  submitted to the GUDID data base. Sec.   830.300.
Two years after publication of a final rule....  The label and package of implantable, life-supporting, and life-
                                                  sustaining devices that are not class III devices or licensed
                                                  under the PHS Act must bear a UDI. Sec.   801.20(b)(2).
                                                 Data for implantable, life-supporting, and life-sustaining
                                                  devices that are not class III devices or licensed under the
                                                  PHS Act and that are required to be labeled with a UDI, must
                                                  be submitted to the GUDID data base. Sec.   830.300.
                                                 All implantable devices required to be labeled with a UDI must
                                                  bear a UDI as a permanent marking on the device itself. Sec.
                                                  801.50.
Three years after publication of a final rule..  Class III devices required to be labeled with a UDI must bear a
                                                  UDI as a permanent marking on the device itself if the device
                                                  is (1) a device intended to be used more than once and
                                                  intended to be sterilized before each use, or (2) stand-alone
                                                  software regulated as a medical device. Sec.   801.50.
                                                 The label and package of class II medical devices must bear a
                                                  UDI. Sec.   801.20(b)(3).
                                                 Data for class II devices that are required to be labeled with
                                                  a UDI, must be submitted to the GUDID data base. Sec.
                                                  830.300.
Five years after publication of a final rule...  Class II devices required to be labeled with a UDI must bear a
                                                  UDI as a permanent marking on the device itself if the device
                                                  is (1) a device intended to be used more than once and
                                                  intended to be sterilized before each use, or (2) stand-alone
                                                  software regulated as a medical device. Sec.   801.50.
                                                 The label and package of class I medical devices and devices
                                                  that have not been classified into class I, class II, or class
                                                  III must bear a UDI. Sec.   801.20(b)(4), (5).
                                                 Data for class I devices and devices that have not been
                                                  classified into class I, class II, or class III that are
                                                  required to be labeled with a UDI must be submitted to the
                                                  GUDID data base. Sec.   830.300.
Seven years after publication of a final rule..  Class I devices and devices that have not been classified into
                                                  class I, class II, or class III required to be labeled with a
                                                  UDI must a bear UDI as a permanent marking on the device
                                                  itself if the device is (1) a device intended to be used more
                                                  than once and intended to be sterilized before each use, or
                                                  (2) stand-alone software regulated as a medical device. Sec.
                                                  801.50.
90 days after publication of a final rule......  All other provisions go into effect, although some will have no
                                                  practical effect until other provisions listed in this table
                                                  go into effect.
----------------------------------------------------------------------------------------------------------------

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

IX. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

X. References

    We have not removed any references listed in the July 10, 2012, 
proposed rule. We are adding new references 12 and 13 to account for 
the additional costs attributable to the FDASIA amendment of section 
519(f) of the FD&C Act, specifically the requirement that FDA must 
implement the regulation with respect to devices that are implantable, 
life-supporting, and life-sustaining not later than 2 years after we 
publish a final rule.
    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.
    12. List of medical devices, by product code, that FDA considers to 
be implantable, life-saving, and life-sustaining for purposes of 
section 614 of FDASIA, amending section 519(f) of the FD&C Act, 
November 2012.
    13. Addendum to the Preliminary Regulatory Impact Analysis of the 
Proposed Rule to Require a Unique Device Identification System, Docket 
No. FDA-2011-N-0090.

List of Subjects in 21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq., as amended) and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR part 801, as 
proposed to be amended in the Federal Register of July 10, 2012 (77 FR 
40736), be further amended as follows:

PART 801--LABELING

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


[[Page 69399]]


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

Subpart B--[Amended]

    2. Revise Sec.  801.20(b) to read as follows:


Sec.  801.20  Label to bear a unique device identifier (UDI).

* * * * *
    (b) Effective dates. The requirements of paragraph (a) of this 
section become effective:
    (1) If the device is a class III medical device or is a device 
licensed under section 351 of the Public Health Service Act, as 
amended, 5 U.S.C. 262, [A DATE WILL BE ADDED THAT IS 1 YEAR AFTER DATE 
OF PUBLICATION OF THE FINAL RULE IN THE Federal Register];
    (2) If the device is an implantable, life-supporting, or life-
sustaining device, and is not a class III device or a device licensed 
under section 351 of the Public Health Service Act, as amended, 5 
U.S.C. 262, [A DATE WILL BE ADDED THAT IS 2 YEARS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
    (3) If the device is a class II medical device not covered by 
paragraph (2), [A DATE WILL BE ADDED THAT IS 3 YEARS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
    (4) If the device is a class I medical device not covered by 
paragraph (2), [A DATE WILL BE ADDED THAT IS 5 YEARS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
    (5) If the device is not classified into class I, II, or III, [A 
DATE WILL BE ADDED THAT IS 5 YEARS AFTER DATE OF PUBLICATION OF THE 
FINAL RULE IN THE Federal Register].
* * * * *
    3. Revise Sec.  801.50(d) to read as follows:


Sec.  801.50  Devices that must be directly marked with a unique device 
identifier.

* * * * *
    (d) Effective dates. The requirements of this section apply to a 
device that is an implantable, life-supporting, or life-sustaining 
device [A DATE WILL BE ADDED THAT IS 2 YEARS AFTER DATE OF PUBLICATION 
OF THE FINAL RULE IN THE Federal Register], and to any other device 2 
years after the date that applies to the device under Sec.  801.20(b).
* * * * *

    Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28015 Filed 11-16-12; 8:45 am]
BILLING CODE 4160-01-P