Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Rules and Regulations 2057 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 16, 801, 803, 806, 810, 

814, 820, 821, 822, and 830 

[Docket No. FDA–2017–D–6841] 

Unique Device Identification: Policy 

Regarding Compliance Dates for Class 

I and Unclassified Devices; 

Immediately in Effect Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the 

guidance for industry and FDA Staff 

entitled ‘‘Unique Device Identification: 

Policy Regarding Compliance Dates for 

Class I and Unclassified Devices; 

Immediately in Effect Guidance for 

Industry and Food and Drug 

Administration Staff.’’ This guidance 

describes FDA’s intention with respect 

to the enforcement of unique device 

identification requirements for certain 

class I and unclassified devices. FDA 

does not intend to enforce standard date 

formatting, labeling, and Global Unique 

Device Identification Database (GUDID) 

data submission requirements under 

Agency regulations for these devices 

before September 24, 2020. In addition, 

FDA does not intend to enforce direct 

mark requirements under an Agency 

regulation for these devices before 

September 24, 2022. The policy 

described in this guidance does not 

apply to implantable, life-supporting, or 

life-sustaining devices. The guidance 

document is immediately in effect, but 

it remains subject to comment in 

accordance with the Agency’s good 

guidance practices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 16, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–6841 for ‘‘Unique Device 

Identification: Policy Regarding 

Compliance Dates for Class I and 

Unclassified Devices; Immediately in 

Effect Guidance for Industry and Food 

and Drug Administration Staff.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Unique Device 

Identification: Policy Regarding 

Compliance Dates for Class I and 

Unclassified Devices; Immediately in 

Effect Guidance for Industry and Food 

and Drug Administration Staff’’ to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: For 

Center for Devices and Radiological 

Health-regulated devices: Loretta Chi, 

Unique Device Identifier Regulatory 

Policy Support, 301–796–5995, email: 

GUDIDSupport@fda.hhs.gov. For Center 


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2058 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Rules and Regulations 

for Biologics Evaluation and Researchregulated devices: Stephen Ripley, 

Office of Communication, Outreach, and 

Development, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911, or call 

1–800–835–4709 or 240–402–8010. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Unique Device 

Identification: Policy Regarding 

Compliance Dates for Class I and 

Unclassified Devices; Immediately in 

Effect Guidance for Industry and Food 

and Drug Administration Staff.’’ In the 

September 24, 2013, Federal Register 

(78 FR 58786), FDA published a final 

rule establishing a unique device 

identification system designed to 

adequately identify medical devices 

during their distribution and use (the 

UDI Rule). Under § 801.20 (21 CFR 

801.20) a device is required to bear a 

unique device identifier (UDI) on its 

label and packages unless an exception 

or alternative applies. Special labeling 

requirements apply to stand-alone 

software regulated as a device (§ 801.50 

(21 CFR 801.50)). Under § 830.300 (21 

CFR 830.300) data pertaining to the key 

characteristics of each device required 

to bear a UDI must be submitted to the 

GUDID. Devices that must bear UDIs on 

their labels and that are intended to be 

used more than once and reprocessed 

between uses must be directly marked 

with a UDI (§ 801.45 (21 CFR 801.45)). 

In addition, § 801.18 (21 CFR 801.18) 

requires certain dates on device labels to 

be in a standard format. 

UDI requirements are being phased in 

over 7 years according to a schedule of 

compliance dates established in the UDI 

Rule ranging from September 24, 2014, 

to September 24, 2020. The compliance 

dates established for class I and 

unclassified devices—other than 

implantable, life-supporting, or lifesustaining (I/LS/LS) devices—are 

September 24, 2018, for labeling, GUDID 

submission, and standard date format 

requirements, and September 24, 2020, 

for direct mark requirements. 

FDA does not intend to enforce 

standard date formatting, UDI labeling, 

and GUDID data submission 

requirements under §§ 801.18, 801.20, 

801.50, and 830.300 for class I and 

unclassified devices, other than I/LS/LS 

devices, before September 24, 2020. 

FDA also does not intend to enforce 

direct mark requirements under § 801.45 

for these devices before September 24, 

2022. This policy does not apply to 

class I devices that FDA has by 

regulation exempted from the good 

manufacturing practice requirements 

because such devices are excepted from 

UDI requirements (see § 801.30(a)(2) (21 

CFR 801.30(a)(2))). 

In addition, finished class I and 

unclassified devices, other than I/LS/LS 

devices, manufactured and labeled prior 

to September 24, 2018, are excepted 

from UDI labeling requirements under 

§§ 801.20 and 801.50, as well as from 

GUDID data submission requirements 

for a period of 3 years after the 

established compliance date or until 

September 24, 2021. (See §§ 801.30(a)(1) 

and 830.300(a).) We also do not intend 

to enforce standard date format 

requirements under § 801.18 during that 

same 3-year period for finished class I 

and unclassified devices, other than I/ 

LS/LS devices, manufactured and 

labeled before September 24, 2018. 

Pursuant to § 801.30(a)(1), finished 

class I and unclassified devices, other 

than I/LS/LS devices, manufactured and 

labeled prior to September 24, 2018, 

would also be excepted from direct 

marking requirements until September 

24, 2021. However, with the exception 

of I/LS/LS devices, we do not intend to 

enforce direct mark requirements before 

September 24, 2022, for class I and 

unclassified devices (including those 

manufactured and labeled prior to 

September 24, 2018). We believe this 

policy regarding direct mark compliance 

dates is appropriate because it is not in 

the best interest of the public health for 

labelers of class I and unclassified 

devices to prioritize remediating devices 

in inventory to meet direct mark 

requirements prior to addressing direct 

marking, and its impact on the safety 

and effectiveness, for devices 

manufactured following labelers’ full 

implementation of UDI. 

Fully realizing the benefits of the 

unique device identification system 

depends on UDI being integrated into 

data sources throughout our health care 

system, including in the supply chain, 

electronic health records, and registries. 

This requires UDI data to be of a high 

quality such that all stakeholders in the 

health care community have sufficient 

confidence in the accuracy and 

completeness of that data. 

To fully reap the public health 

benefits and a return on investment of 

the unique device identification system, 

the Agency intends to focus its 

resources on addressing existing 

implementation challenges and 

optimizing the quality and utility of UDI 

data for higher-risk devices before 

focusing on UDI implementation issues 

for lower-risk devices. Undertaking this 

endeavor now will help ensure the 

transition from development of the 

unique device identification system to 

widespread use and sustainability. 

This guidance is being implemented 

without prior public comment because 

the Agency has determined that prior 

public participation is not feasible or 

appropriate (§ 10.115(g)(2) (21 CFR 

10.115(g)(2))). FDA has determined that 

this guidance document presents a less 

burdensome policy that is consistent 

with public health. Although this 

guidance is immediately in effect, FDA 

will consider all comments received and 

revise the guidance document as 

appropriate. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the current thinking 

of FDA on ‘‘Unique Device 

Identification: Policy Regarding 

Compliance Dates for Class I and 

Unclassified Devices; Immediately in 

Effect Guidance for Industry and Food 

and Drug Administration Staff.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. A 

search capability for all Center for 

Biologics Evaluation and Research 

guidance documents is available at 

https://www.fda.gov/BiologicsBlood

Vaccines/Guidance

ComplianceRegulatoryInformation/ 

default.htm. This guidance document is 

also available at https://

www.regulations.gov. Persons unable to 

download an electronic copy of 

‘‘Unique Device Identification: Policy 

Regarding Compliance Dates for Class I 

and Unclassified Devices; Immediately 

in Effect Guidance for Industry and 

Food and Drug Administration Staff’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 17029 to 

identify the guidance you are 

requesting. 


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Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Rules and Regulations 2059 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 801 have been approved 

under OMB control number 0910–0485 

and the collections of information in 21 

CFR part 830 have been approved under 

OMB control number 0910–0720. 

Dated: January 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00550 Filed 1–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

National Indian Gaming Commission 

25 CFR Part 575 

Annual Adjustment of Civil Monetary 

Penalty To Reflect Inflation 

AGENCY: National Indian Gaming 

Commission. 

ACTION: Final rule. 

SUMMARY: In compliance with the 

Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015 (the Act) and Office of 

Management and Budget (OMB) 

guidance, the National Indian Gaming 

Commission (NIGC or Commission) is 

amending its civil monetary penalty 

rule to reflect an annual adjustment for 

inflation in order to improve the 

penalty’s effectiveness and maintain its 

deterrent effect. The Act provides that 

the new penalty level must apply to 

penalties assessed after the effective 

date of the increase, including when the 

penalties whose associated violation 

predate the increase. 

DATES: This final rule will have an 

effective date of January 15, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Contact Armando J. Acosta, Senior 

Attorney, Office of General Counsel, 

National Indian Gaming Commission, at 

(202) 632–7003; fax (202) 632–7066 (not 

toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

I. Background 

On November 2, 2015, the President 

signed into law the Federal Civil 

Penalties Inflation Adjustment Act 

Improvements Act of 2015 (Sec. 701 of 

Pub. L. 114–74). Beginning in 2017, the 

Act requires agencies to make annual 

inflationary adjustments to their civil 

monetary penalties by January 15th of 

each year, in accordance with annual 

OMB guidance. 

II. Calculation of Annual Adjustment 

On December 15, 2017, OMB issued 

guidance to agencies to calculate the 

annual adjustment. See M–18–03 

Memorandum for the Heads of 

Executive Departments and Agencies, 

from Mick Mulvaney, Director, Subject: 

Implementation of Penalty Inflation 

Adjustments for 2018, Pursuant to the 

Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015 (December 15, 2017). According to 

OMB, the cost-of-living adjustment 

multiplier for 2018, based on the 

Consumer Price Index (CPI–U) for the 

month of October 2017, not seasonally 

adjusted, is 1.02041. 

Pursuant to this guidance, the 

Commission has calculated the annual 

adjustment level of the civil monetary 

penalty contained in 25 CFR 575.4 

(‘‘The Chairman may assess a civil fine, 

not to exceed $50,276 per violation, 

against a tribe, management contractor, 

or individual operating Indian gaming 

for each notice of violation . . .’’). The 

2018 adjusted level of the civil 

monetary penalty is $51,302 ($50,276 × 

1.02041). 

III. Regulatory Matters 

Regulatory Planning and Review 

This final rule is not a significant rule 

under Executive Order 12866. 

(1) This rule will not have an effect of 

$100 million or more on the economy or 

will not adversely affect, in a material 

way, the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or state, local, or 

tribal governments or communities. 

(2) This rule will not create a serious 

inconsistency or otherwise interfere 

with an action taken or planned by 

another agency. 

(3) This rule does not involve 

entitlements, grants, user fees, or loan 

programs or the rights or obligations of 

recipients. 

(4) This regulatory change does not 

raise novel legal or policy issues. 

Regulatory Flexibility Act 

The Commission certifies that this 

rule will not have a significant 

economic effect on a substantial number 

of small entities under the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) 

because the rule makes annual 

adjustments for inflation. 

Small Business Regulatory Enforcement 

Fairness Act 

This final rule is not a major rule 

under 5 U.S.C. 804(2), the Small 

Business Regulatory Enforcement 

Fairness Act. It will not result in the 

expenditure by state, local, or tribal 

governments, in the aggregate, or by the 

private sector of $100 million or more 

in any one year. The rule will not result 

in a major increase in costs or prices for 

consumers, individual industries, 

federal, state, or local government 

agencies, or geographic regions. Nor will 

this rule have significant adverse effects 

on competition, employment, 

investment, productivity, innovation, or 

the ability of the U.S.-based enterprises 

to compete with foreign-based 

enterprises. 

Unfunded Mandates Reform Act 

This final rule does not impose an 

unfunded mandate of more than $100 

million per year on state, local, or tribal 

governments or the private sector. The 

rule also does not have a significant or 

unique effect on state, local, or tribal 

governments or the private sector. 

Therefore, a statement containing the 

information required by the Unfunded 

Mandates Reform Act (2 U.S.C. 1531 et 

seq.) is not required. 

Takings 

Under the criteria in Executive Order 

12630, this final rule does not affect 

individual property rights protected by 

the Fifth Amendment nor does it 

involve a compensable ‘‘taking.’’ Thus, 

a takings implication assessment is not 

required. 

Federalism 

Under the criteria in Executive Order 

13132, this final rule has no substantial 

direct effect 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. 

Civil Justice Reform 

This final rule complies with the 

requirements of Executive Order 12988. 

Specifically, this rule has been reviewed 

to eliminate errors and ambiguity and 

written to minimize litigation. It is 

written in clear language and contains 

clear legal standards. 

Consultation With Indian Tribes 

In accordance with the President’s 

memorandum of April 29, 1994, 

Government-to-Government Relations 

with Native American Tribal 

Governments, Executive Order 13175 

(59 FR 22951, November 6, 2000), the 


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