8190 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Rules and Regulations 

(e) An ability to move participants 

with multiple barriers to employment, 

including individuals described in 

§ 641.570(b) or § 641.520(a)(2) through 

(9), into unsubsidized employment; 

* * * * * 

Subpart E—Services to Participants 

■ 5. Amend § 641.520 by revising the 

section heading and paragraphs (a)(7) 

and (8) and adding paragraph (a)(9) to 

read as follows: 

§ 641.520 Are there any priorities that 

grantees and sub-recipients must use in 

selecting eligible individuals for 

participation in the Senior Community 

Service Employment Program? 

(a) * * * 

(7) Have failed to find employment 

after using services provided through 

the one-stop delivery system; 

(8) Are homeless or are at risk for 

homelessness; or 

(9) Are formerly incarcerated 

individuals as defined in § 641.140. 

(OAA sec. 518(b).) 

* * * * * 

■ 6. Amend § 641.570 by revising 

paragraphs (b)(4) and (5) and adding 

paragraph (b)(6) to read as follows: 

§ 641.570 Is there a time limit for 

participation in the program? 

* * * * * 

(b) * * * 

(4) Live in an area with persistent 

unemployment and are individuals with 

severely limited employment prospects; 

(5) Have limited English proficiency 

or low literacy skills; or 

(6) Are formerly incarcerated 

individuals as defined in § 641.140. 

* * * * * 

Subpart G—Performance 

Accountability 

■ 7. Amend § 641.710 by revising 

paragraphs (g)(12) and (13) and adding 

paragraph (g)(14) to read as follows: 

§ 641.710 How are the performance 

measures defined? 

* * * * * 

(g) * * * 

(12) Have failed to find employment 

after utilizing services provided under 

title I of the Workforce Innovation and 

Opportunity Act; 

(13) Are homeless or at risk for 

homelessness; or 

(14) Are formerly incarcerated 

individuals as defined in § 641.140. 

Angela Hanks, 

Acting Assistant Secretary for Employment 

and Training, Labor. 

[FR Doc. 2022–02680 Filed 2–11–22; 8:45 am] 

BILLING CODE 4510–FN–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2021–N–0999] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Adjunctive Predictive Cardiovascular 

Indicator 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the adjunctive predictive 

cardiovascular indicator 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 

adjunctive predictive cardiovascular 

indicator’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 February 

14, 2022. The classification was 

applicable on March 16, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Aneesh Deoras, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2564, Silver Spring, 

MD 20993–0002, 240–402–4363, 

Aneesh.Deoras@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

adjunctive predictive cardiovascular 

indicator 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 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

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 

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 


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Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Rules and Regulations 8191 

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. 

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 September 26, 2016, FDA received 

Edwards Lifesciences, LLC’s request for 

De Novo classification of the Acumen 

Hypotension Prediction Index (HPI) 

Feature Software. 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 March 16, 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 870.2210.1 We have named the 

generic type of device adjunctive 

predictive cardiovascular indicator, and 

it is identified as a prescription device 

that uses software algorithms to analyze 

cardiovascular vital signs and predict 

future cardiovascular status or events. 

This device is intended for adjunctive 

use with other physical vital sign 

parameters and patient information and 

is not intended to independently direct 

therapy. 

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—ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Delayed or incorrect treatment due to erroneous device output resulting from software malfunction or algorithm error.Software verification, validation, and hazard 

analysis; 

Non-clinical performance testing; 

Clinical performance testing; and Labeling. 

Delayed or incorrect treatment due to user misinterpretation or overreliance on indicator ........... Usability assessment, 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. 

At the time of classification, 

adjunctive predictive cardiovascular 

indicators are for prescription use only. 

Prescription devices are exempt from 

the requirement for adequate directions 

for use for the layperson under section 

502(f)(1) of the FD&C Act (21 U.S.C. 

352(f)(1)) and 21 CFR 801.5, as long as 

the conditions of 21 CFR 801.109 are 

met. 

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: 

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 § 870.2210 to subpart C to read 

as follows: 

§ 870.2210 Adjunctive predictive 

cardiovascular indicator. 

(a) Identification. The adjunctive 

predictive cardiovascular indicator is a 

prescription device that uses software 

algorithms to analyze cardiovascular 


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8192 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Rules and Regulations 

vital signs and predict future 

cardiovascular status or events. This 

device is intended for adjunctive use 

with other physical vital sign 

parameters and patient information and 

is not intended to independently direct 

therapy. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) A software description and the 

results of verification and validation 

testing based on a comprehensive 

hazard analysis and risk assessment 

must be provided, including: 

(i) A full characterization of the 

software technical parameters, 

including algorithms; 

(ii) A description of the expected 

impact of all applicable sensor 

acquisition hardware characteristics and 

associated hardware specifications; 

(iii) A description of sensor data 

quality control measures; 

(iv) A description of all mitigations 

for user error or failure of any subsystem 

components (including signal detection, 

signal analysis, data display, and 

storage) on output accuracy; 

(v) A description of the expected time 

to patient status or clinical event for all 

expected outputs, accounting for 

differences in patient condition and 

environment; and 

(vi) The sensitivity, specificity, 

positive predictive value, and negative 

predictive value in both percentage and 

number form. 

(2) A scientific justification for the 

validity of the predictive cardiovascular 

indicator algorithm(s) must be provided. 

This justification must include 

verification of the algorithm 

calculations and validation using an 

independent data set. 

(3) A human factors and usability 

engineering assessment must be 

provided that evaluates the risk of 

misinterpretation of device output. 

(4) A clinical data assessment must be 

provided. This assessment must fulfill 

the following: 

(i) The assessment must include a 

summary of the clinical data used, 

including source, patient demographics, 

and any techniques used for annotating 

and separating the data. 

(ii) The clinical data must be 

representative of the intended use 

population for the device. Any selection 

criteria or sample limitations must be 

fully described and justified. 

(iii) The assessment must demonstrate 

output consistency using the expected 

range of data sources and data quality 

encountered in the intended use 

population and environment. 

(iv) The assessment must evaluate 

how the device output correlates with 

the predicted event or status. 

(5) Labeling must include: 

(i) A description of what the device 

measures and outputs to the user; 

(ii) Warnings identifying sensor 

acquisition factors that may impact 

measurement results; 

(iii) Guidance for interpretation of the 

measurements, including a statement 

that the output is adjunctive to other 

physical vital sign parameters and 

patient information; 

(iv) A specific time or a range of times 

before the predicted patient status or 

clinical event occurs, accounting for 

differences in patient condition and 

environment; 

(v) Key assumptions made during 

calculation of the output; 

(vi) The type(s) of sensor data used, 

including specification of compatible 

sensors for data acquisition; 

(vii) The expected performance of the 

device for all intended use populations 

and environments; and 

(viii) Relevant characteristics of the 

patients studied in the clinical 

validation (including age, gender, race 

or ethnicity, and patient condition) and 

a summary of validation results. 

Dated: February 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03096 Filed 2–11–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 880 

[Docket No. FDA–2021–N–0994] 

Medical Devices; General Hospital and 

Personal Use Devices; Classification 

of the Spore Test Strip 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is classifying the spore test strip 

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 

spore test strip’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 February 

14, 2022. The classification was 

applicable on March 30, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Clarence Murray III, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4506, Silver Spring, 

MD 20993–0002, 301–796–0270, 

Clarence.Murray@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

spore test strip 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, 

in part 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 


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