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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Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Rules and Regulations 8193 

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. 

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 

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 (PMA) 

to market a substantially equivalent 

device (see section 513(i) of the FD&C 

Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

For this device, FDA issued an order 

on July 1, 2011, finding the VERIFY S40 

Biological Indicator Kit not substantially 

equivalent to a predicate not subject to 

PMA. Thus, the device remained in 

class III in accordance with section 

513(f)(1) of the FD&C Act when we 

issued the order. 

On August 1, 2011, FDA received 

STERIS Corporation’s request for De 

Novo classification of the VERIFY Spore 

Test Strip for S40. 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 30, 2012, 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 880.6887.1 We have named the 

generic type of device spore test strip, 

and it consists of a carrier or strip with 

a known number of spores, at least 5 

log10 per strip, of known resistance to a 

particular liquid chemical sterilant in a 

liquid chemical sterilant processing 

system. A ‘‘no growth’’ result from the 

spore test strip after the specified 

predetermined incubation period 

indicates that the liquid chemical 

sterilization process achieved the 

conditions necessary to kill the 

specified minimum number of viable 

spores on the test strip, which is 5 log10

spores/strip. It does not confirm the 

expected full performance of the liquid 

chemical sterilant processing cycle 

because full performance is a 6 log10

spore kill in a full liquid chemical 

sterilization cycle. 

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—SPORE TEST STRIP RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

User handling error due to false fail spore test strip device result due to 

technical malfunction.

Spore strip characterization, Simulated use testing, Shelf life, and Labeling. 

User handling error due to false pass spore test strip device result due 

to technical malfunction.

Spore strip characterization, Simulated use testing, Shelf life, and Labeling. 

User handling error due to misunderstanding spore test strip device 

use instructions.

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. 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 


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8194 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Rules and Regulations 

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 880 

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 880 is 

amended as follows: 

PART 880—GENERAL HOSPITAL AND 

PERSONAL USE DEVICES 

■ 1. The authority citation for part 880 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 880.6887 to subpart G to read 

as follows: 

§ 880.6887 Spore test strip. 

(a) Identification. The spore test strip 

consists of a carrier or strip with a 

known number of spores, at least 5 log10

per strip, of known resistance to a 

particular liquid chemical sterilant in a 

liquid chemical sterilant processing 

system. A ‘‘no growth’’ result from the 

spore test strip after the specified 

predetermined incubation period 

indicates that the liquid chemical 

sterilization process achieved the 

conditions necessary to kill the 

specified minimum number of viable 

spores on the test strip which is 5 log10

spores/strip; it does not confirm the 

expected full performance of the liquid 

chemical sterilant processing cycle 

because full performance is a 6 log10

spore kill in a full liquid chemical 

sterilization cycle. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Spore strip characterization. (i) 

Population of viable spores on strip 

shall be a minimum of 5 log10 after 

physical wash off of spores from the 

strip by exposure to liquid chemical 

sterilant in the liquid chemical sterilant 

processing system, which should be 

validated over the claimed shelf life. 

(ii) The resistance characteristics of 

the viable spores on the strip should be 

defined and be validated over the 

claimed shelf life. 

(iii) The spore strip description 

should address the carrier material, how 

the spores are placed on the carrier, and 

whether there is any feature that 

minimizes spore wash off. Bacteriostasis 

of the spore strip materials should be 

evaluated. 

(iv) Incubation time for viable spores 

on the strip should be validated under 

the specified incubation conditions over 

the claimed shelf life. 

(2) Simulated Use Testing. Simulated 

use testing should demonstrate 

performance of spore test strip in liquid 

chemical sterilant/high level 

disinfectant under worst case in use 

conditions over the claimed shelf life. 

(3) Labeling. Labeling should specify 

appropriate instructions, warnings, 

cautions, limitations, and information 

relating to viable spore population, 

resistance characteristics, and 

interpretation of a ‘‘no growth’’ result. 

Dated: February 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03104 Filed 2–11–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Parts 14, 17, 20, 26, 28, 30, 81, 

103, 180, and 570 

[Docket No. FR–6285–F–01] 

HUD Office of Hearings and Appeals 

AGENCY: Office of Hearings and Appeals, 

HUD. 

ACTION: Final rule. 

SUMMARY: This final rule amends HUD’s 

regulations regarding HUD’s Office of 

Hearings and Appeals (OHA). This rule 

makes conforming changes to HUD 

regulations to reflect the office’s proper 

title, to remove references to the 

terminated HUD Board of Contract 

Appeals, and to add a reference to 

recent Supreme Court precedent 

regarding the proper appointment 

procedure for administrative law judges 

and administrative judges. 

DATES: Effective March 16, 2022. 

FOR FURTHER INFORMATION CONTACT: 

J. Jeremiah Mahoney, Chief 

Administrative Law Judge, Office of 

Hearings and Appeals, Department of 

Housing and Urban Development, 451 

7th Street SW, Room B–133, 

Washington, DC 20410, 202–254–0000 

(not a toll-free number). Hearing- or 

speech-impaired individuals may access 

this number via TTY by calling the 

Federal Relay Service at 800–877–8339 

(toll-free number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

The HUD Office of Hearings and 

Appeals (OHA) is an independent 

judicial office within HUD’s Office of 

the Secretary. The OHA is headed by 

the Chief Administrative Law Judge, 

who supervises the judges and the 

professional and administrative support 

staffs. 

Each Administrative Judge and each 

Administrative Law Judge is appointed 

by the HUD Secretary as an Officer of 

the United States. The Judges also may 

be appointed through contracts with 

other U.S. Department heads and 

Federal Agency heads to conduct 

hearings and issue decisions on matters 

before their respective agencies. 

The OHA Judges function as 

independent and impartial triers of fact 

responsible for presiding over 

adversarial hearings, and adjudicating 

appeals, based upon alleged violations 

of Federal statutes or their 

implementing regulations. 

Hearing procedures are established by 

agency regulations and are guided by 

the rules applicable to trials in a U.S. 

district court. In each case, the judge 

makes an impartial decision based upon 

the law, and the facts established by the 

evidence. 

II. This Final Rule 

This final rule updates HUD’s 

regulations in 24 CFR parts 14, 17, 20, 

26, 28, 30, 81, 103, 180, and 570, to 

reflect that the office’s title is ‘‘Office of 

Hearings and Appeals,’’ as changed by 

the HUD Secretary. These HUD 

regulations contain outdated references 

to the ‘‘Office of Administrative Law 

Judges,’’ ‘‘Office of Appeals,’’ and 

‘‘Board of Contract Appeals.’’ This final 

rule updates HUD regulations 

throughout Title 24 to reflect these 

changes. While this final rule updates 

those sections of Title 24 that use 

outdated language that also implicate 

the hearing procedures at 24 CFR part 

180, there are other sections of Title 24 

that rely on the hearing procedures at 24 

CFR part 180, which do not require the 

conforming amendments made by this 

final rule, including 24 CFR parts 1, 3, 

6, 8, and 146. These sections of Title 24 

implement federal civil rights statutes, 

which continue to rely on 24 CFR part 

180 for administrative enforcement 

procedures. 


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