Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 2547 

Official Methods of Analysis, 21st 

edition, 2019. 

(ii) Determination of Sulfite in Food 

by Liquid Chromatography Tandem 

Mass Spectrometry: Collaborative 

Study, Katherine S. Carlos and Lowri S. 

De Jager; Journal of AOAC International, 

Vol. 100, No. 6, 2017, pp. 1785–1794. 

(2) [Reserved] 

Appendix A to Part 101 [Removed and 

Reserved] 

■ 3. Remove and reserve appendix A to 

part 101. 

PART 130—FOOD STANDARDS: 

GENERAL 

■ 4. The authority citation for part 130 

continues to read as follows: 

Authority: 21 U.S.C. 321, 336, 341, 343, 

371. 

■ 5. Amend § 130.9 by revising 

paragraph (a) and adding paragraph (c) 

to read as follows: 

§ 130.9 Sulfites in standardized food. 

(a) Any standardized food that 

contains a sulfiting agent or 

combination of sulfiting agents that is 

functional and provided for in the 

applicable standard or that is present in 

the finished food at a detectable 

concentration is misbranded unless the 

presence of the sulfiting agent or agents 

is declared on the label of the food. A 

detectable amount of sulfiting agent is 

10 parts per million (ppm or mg/kg) or 

more of the sulfite in the finished food. 

The concentration of sulfite in the 

finished food will be determined using 

either: 

(1) Determination of Sulfite in Food 

by Liquid Chromatography Tandem 

Mass Spectrometry; or 

(2) AOAC Official Method 990.28. 

* * * * * 

(c) The standards required in this 

section are incorporated by reference 

into this section with the approval of 

the Director of the Federal Register 

under 5 U.S.C. 552(a) and 1 CFR part 51. 

All approved material is available for 

inspection at the Food and Drug 

Administration, Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500, 

and available from AOAC International, 

2275 Research Blvd., Ste. 300, 

Rockville, MD 20850–3250. It is also 

available for inspection at the National 

Archives and Records Administration 

(NARA). For information on the 

availability of this material at NARA, 

email fedreg.legal@nara.gov or go to 

www.archives.gov/federal-register/cfr/ 

ibr-locations.html. 

(1) AOAC Official Method 990.28, 

Sulfites in Foods, Optimized MonierWilliams Method, Section 47.3.43, 

Official Methods of Analysis, 21st 

edition, 2019. 

(2) Determination of Sulfite in Food 

by Liquid Chromatography Tandem 

Mass Spectrometry: Collaborative 

Study, Katherine S. Carlos and Lowri S. 

De Jager; Journal of AOAC International, 

Vol. 100, No. 6, 2017, pp. 1785–1794. 

Dated: January 11, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–00816 Filed 1–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2021–N–0914] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Electrocardiograph Software for Overthe-Counter Use 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the electrocardiograph 

software for over-the-counter use into 

class II (special controls). The special 

controls that apply to the device type 

are identified in this order and will be 

part of the codified language for the 

electrocardiograph software for overthe-counter use’s classification. We are 

taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices. 

DATES: This order is effective January 

18, 2022. The classification was 

applicable on September 11, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Luke Ralston, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2311, Silver Spring, 

MD 20993–0002, 301–796–6362, 

Luke.Ralston@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

electrocardiograph software for overthe-counter use as class II (special 

controls), which we have determined 

will provide a reasonable assurance of 

safety and effectiveness. In addition, we 

believe this action will enhance 

patients’ access to beneficial innovation, 

by placing the device into a lower 

device class than the automatic class III 

assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (see 21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). A device sponsor 

may utilize either procedure for De 

Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 


khammond on DSKJM1Z7X2PROD with RULES
2548 Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. The change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

placed within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation. When FDA 

classifies a device into class I or II via 

the De Novo process, the device can 

serve as a predicate for future devices of 

that type, including for 510(k)s (see 

section 513(f)(2)(B)(i) of the FD&C Act). 

As a result, other device sponsors do not 

have to submit a De Novo request or 

premarket approval application to 

market a substantially equivalent device 

(see section 513(i) of the FD&C Act, 

defining ‘‘substantial equivalence’’). 

Instead, sponsors can use the lessburdensome 510(k) process, when 

necessary, to market their device. 

II. De Novo Classification 

On August 14, 2018, FDA received 

Apple Inc.’s request for De Novo 

classification of the ECG App. FDA 

reviewed the request in order to classify 

the device under the criteria for 

classification set forth in section 

513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on September 11, 2018, 

FDA issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 870.2345.1 We have named the 

generic type of device 

electrocardiograph software for overthe-counter use, and it is identified as 

a device that creates, analyzes, and 

displays electrocardiograph data and 

can provide information for identifying 

cardiac arrhythmias. This device is not 

intended to provide a diagnosis. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the measures 

required to mitigate these risks in table 

1. 

TABLE 1—ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Poor quality electrocardiograph (ECG) signal resulting in failure to detect arrhythmia.Clinical performance testing, Human factors testing, and Labeling. 

Misinterpretation and/or over-reliance on device output, leading to: 

• Failure to seek treatment despite acute symptoms 

• Discontinuing or modifying treatment for chronic heart condition 

Human factors testing, and Labeling. 

False negative resulting in failure to identify arrhythmia and delay of 

further evaluation or treatment.

Clinical performance testing, Software verification, validation, and hazard analysis; Non-clinical performance testing; and Labeling. 

False positive resulting in additional unnecessary medical procedures .. Clinical performance testing; Software verification, validation, and hazard analysis; Non-clinical performance testing; and Labeling. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. For a device 

to fall within this classification, and 

thus avoid automatic classification in 

class III, it would have to comply with 

the special controls named in this final 

order. The necessary special controls 

appear in the regulation codified by this 

order. This device is subject to 

premarket notification requirements 

under section 510(k) of the FD&C Act. 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) 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. 

IV. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. 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. 3501–3521). The 

collections of information in the 

guidance document ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ have 

been approved under OMB control 

number 0910–0844; the collections of 

information in 21 CFR part 814, 

subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 870 

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 870 is 

amended as follows: 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 2549 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for part 870 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 870.2345 to subpart C to read 

as follows: 

§ 870.2345 Electrocardiograph software 

for over-the-counter use. 

(a) Identification. An 

electrocardiograph software device for 

over-the-counter use creates, analyzes, 

and displays electrocardiograph data 

and can provide information for 

identifying cardiac arrhythmias. This 

device is not intended to provide a 

diagnosis. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing under 

anticipated conditions of use must 

demonstrate the following: 

(i) The ability to obtain an 

electrocardiograph of sufficient quality 

for display and analysis; and 

(ii) The performance characteristics of 

the detection algorithm as reported by 

sensitivity and either specificity or 

positive predictive value. 

(2) Software verification, validation, 

and hazard analysis must be performed. 

Documentation must include a 

characterization of the technical 

specifications of the software, including 

the detection algorithm and its inputs 

and outputs. 

(3) Non-clinical performance testing 

must validate detection algorithm 

performance using a previously 

adjudicated data set. 

(4) Human factors and usability 

testing must demonstrate the following: 

(i) The user can correctly use the 

device based solely on reading the 

device labeling; and 

(ii) The user can correctly interpret 

the device output and understand when 

to seek medical care. 

(5) Labeling must include: 

(i) Hardware platform and operating 

system requirements; 

(ii) Situations in which the device 

may not operate at an expected 

performance level; 

(iii) A summary of the clinical 

performance testing conducted with the 

device; 

(iv) A description of what the device 

measures and outputs to the user; and 

(v) Guidance on interpretation of any 

results. 

Dated: January 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00827 Filed 1–14–22; 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 rule is effective January 18, 

2022. This final rule is applicable 

beginning on January 15, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Armando J. Acosta, Senior Attorney, 

Office of General Counsel, National 

Indian Gaming Commission, at (202) 

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

In December of every year, OMB 

issues guidance to agencies to calculate 

the annual adjustment. According to 

OMB, the cost-of-living adjustment 

multiplier for fiscal year 2022 is 

1.06222, based on the Consumer Price 

Index for the month of October 2021, 

not seasonally adjusted. 

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 $54,157 per violation, 

against a tribe, management contractor, 

or individual operating Indian gaming 

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

2022 adjusted level of the civil 

monetary penalty is $57,527 ($54,157 × 

1.06222). 

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 


khammond on DSKJM1Z7X2PROD with RULES