Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 6415 

thereafter be published continuously in the 

Chart Supplement. 

AGL MN D St. Cloud, MN [Amended] 

St. Cloud Regional Airport, MN 

(Lat. 45°32′46′′ N, long. 94°03′34′′ W) 

That airspace extending upward from the 

surface to and including 3,500 feet MSL 

within a 4.2-mile radius of the St. Cloud 

Regional Airport. This Class D airspace area 

is effective during the specific dates and 

times established in advance by a Notice to 

Airmen. The effective dates and times will 

thereafter be continuously published in the 

Chart Supplement. 

Paragraph 6002 Class E Airspace 

Designated as a Surface Area. 

* * * * * 

AGL MN E2 Rochester, MN [Amended] 

Rochester International Airport, MN 

(Lat. 43°54′30′′ N, long. 92°30′00′′ W) 

Within a 4.4-mile radius of Rochester 

International Airport. This Class E airspace 

area is effective during the specific dates and 

times established by a Notice to Airmen. The 

effective dates and times will thereafter be 

continuously published in the Chart 

Supplement. 

AGL MN E2 St. Cloud, MN [Amended] 

St. Cloud Regional Airport, MN 

(Lat. 45°32′46′′ N, long. 94°03′34′′ W) 

Within a 4.2-mile radius of St. Cloud 

Regional Airport. This Class E airspace area 

is effective during the specific dates and 

times established by a Notice to Airmen. The 

effective dates and times will thereafter be 

continuously published in the Chart 

Supplement. 

Paragraph 6004 Class E Airspace Areas 

Designated as an Extension to a Class D or 

Class E Surface Area. 

* * * * * 

AGL MN E4 Rochester, MN [Removed] 

AGL MN E4 St. Cloud, MN [Amended] 

St. Cloud Regional Airport, MN 

(Lat. 45°32′46′′ N, long. 94°03′34′′ W) 

St. Cloud VOR/DME 

(Lat. 45°32′58′′ N, long. 94°03′31′′ W) 

That airspace extending upward from the 

surface within 2.4 miles each side of St. 

Cloud VOR/DME 140° radial extending from 

the 4.2-mile radius of St. Cloud Regional 

Airport to 7 miles southeast of the St. Cloud 

VOR/DME. 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AGL MN E5 Rochester, MN [Amended] 

Rochester International Airport, MN 

(Lat. 43°54′30′′ N, long. 92°30′00′′ W) 

Rochester Intl.: RWY 31–LOC 

(Lat. 43°55′19′′ N, long. 92°30′54′′ W) 

Rochester Intl.: RWY 13–LOC 

(Lat. 43°54′06′′ N, long. 92°29′02′′ W) 

Mayo Clinic-St. Mary’s Hospital, MN 

(Lat. 44°01′11′′ N, long. 92°28′59′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.9-mile 

radius of the Rochester International Airport, 

and within 2 miles each side of the 132° 

bearing from the Rochester International 

Airport extending from the 6.9-mile radius of 

Rochester International Airport to 10.9 miles 

southeast of Rochester International Airport, 

and within 4 miles each side of the 132° 

bearing from the Rochester Intl.: RWY 31– 

LOC extending from the 6.9-mile radius of 

Rochester International Airport to 7.5 miles 

southeast of Rochester International Airport, 

and within 3.9 miles each side of the 312° 

bearing from the Rochester Intl.: RWY 13– 

LOC extending from the 6.9-mile radius of 

Rochester International Airport to 11.4 miles 

northwest of Rochester International Airport, 

and within a 6.4-mile radius of the Mayo 

Clinic-St. Mary’s Hospital. 

* * * * * 

AGL MN E5 St. Cloud, MN [Amended] 

St. Cloud Regional Airport, MN 

(Lat. 45°32′46′′ N, long. 94°03′34′′ W) 

St. Cloud VOR/DME 

(Lat. 45°32′58′′ N, long. 94°03′31′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.7-mile 

radius of St. Cloud Regional Airport, and 

within 2.4 miles each side of the St. Cloud 

VOR/DME 140° extending from the 6.7-mile 

radius of the airport to 7 miles southeast of 

the St. Cloud VOR/DME. 

Issued in Fort Worth, Texas, on January 31, 

2022. 

Martin A. Skinner, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. 2022–02276 Filed 2–3–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2021–N–0807] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the System for Detection of 

Microorganisms and Antimicrobial 

Resistance Using Reporter Expression 

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 system for detection of 

microorganisms and antimicrobial 

resistance using reporter expression 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 

system for detection of microorganisms 

and antimicrobial resistance using 

reporter expression’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 

4, 2022. The classification was 

applicable on December 5, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Tobin Hellyer, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3272, Silver Spring, 

MD 20993–0002, 301–796–6154, 

Tobin.Hellyer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

system for detection of microorganisms 

and antimicrobial resistance using 

reporter expression 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 (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 


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6416 Federal Register / Vol. 87, No. 24 / Friday, February 4, 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. 

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 

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 21 

U.S.C. 360c(f)(2)(B)(i)). 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 21 

U.S.C. 360c(i), defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On March 19, 2019, FDA received 

Roche Molecular Systems, Inc.’s request 

for De Novo classification of the cobas 

vivoDx MRSA. 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 December 5, 2019, 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 866.1655.1 We have named the 

generic type of device system for 

detection of microorganisms and 

antimicrobial resistance using reporter 

expression, and it is identified as an in 

vitro diagnostic device intended for the 

detection and identification of live 

microorganisms and the detection of 

associated antimicrobial drug 

susceptibility or resistance in specimens 

from patients at risk of colonization or 

suspected of infection. 

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—SYSTEM FOR DETECTION OF MICROORGANISMS AND ANTIMICROBIAL RESISTANCE USING REPORTER

EXPRESSION RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Failure to use the device correctly ........................................................... Certain labeling information identified in special controls (b)(1) and (3), 

and Certain design verification and validation identified in special 

control (b)(4)(vii). 

False positive or negative results ............................................................. Certain labeling information identified in special controls (b)(1) and (3), 

Use of certain specimen collection and transport devices identified in 

special control (b)(2), and Certain design verification and validation 

identified in special control (b)(4). 

Failure to interpret results correctly .......................................................... Certain labeling information identified in special controls (b)(1) and (3), 

and Certain design verification and validation identified in special 

control (b)(4)(vii). 

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 


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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 6417 

(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 

parts 801 and 809 regarding labeling, 

have been approved under OMB control 

number 0910–0485. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, 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 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 866.1655 to subpart B to read 

as follows: 

§ 866.1655 System for detection of 

microorganisms and antimicrobial 

resistance using reporter expression. 

(a) Identification. A system for 

detection of microorganisms and 

antimicrobial resistance using reporter 

expression is an in vitro diagnostic 

device intended for the detection and 

identification of live microorganisms 

and the detection of associated 

antimicrobial drug susceptibility or 

resistance in specimens from patients at 

risk of colonization or suspected of 

infection. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The intended use for the device in 

the labeling required under § 809.10 of 

this chapter must include a detailed 

description of the targets the device 

detects, the type of results provided to 

the user, the clinical indications 

appropriate for test use, and the specific 

population(s) for which the device is 

intended. 

(2) Any device used for specimen 

collection and transport must be FDAcleared, approved, or -classified as 

510(k) exempt (standalone or as part of 

a test system) for the collection of the 

specimen types claimed by this device 

and for the maintenance of viability of 

the targeted microorganisms; 

alternatively, the specimen collection 

device must be cleared in a premarket 

submission as a part of this device. 

(3) The labeling required under 

§ 809.10(b) of this chapter must include: 

(i) A detailed description of the 

device, including reagents, instruments, 

ancillary materials, applicable specimen 

collection and transport device(s) and 

control elements, and a detailed 

explanation of the methodology, 

including all pre-analytical methods for 

handling and processing of specimens 

and controls to maintain organism 

viability; 

(ii) Detailed descriptions of the test 

procedure, including the preparation 

and maintenance of quality controls and 

the interpretation of test results; 

(iii) Detailed discussion of the 

performance characteristics of the 

device for all claimed organisms and 

specimen types based on analytical 

studies, including evaluation of 

analytical sensitivity, inclusivity, crossreactivity, potentially interfering 

substances and microorganisms, 

contamination, specimen stability, 

precision, and reproducibility; 

(iv) Detailed discussion of the 

performance characteristics of the 

device observed in a clinical study 

performed on a population that is 

consistent with the intended use 

population in comparison to the results 

obtained by a reference or comparator 

method determined to be acceptable by 

FDA, for microbial detection, 

identification, and antimicrobial 

susceptibility testing; and 

(v) A limiting statement indicating 

that a negative test result does not 

preclude colonization or infection with 

organisms that do not express detectable 

levels of the reporter that is identified 

by the device. 

(4) Design verification and validation 

must include: 

(i) A detailed description of the 

device, including an explanation of the 

technology, hardware, software, and 

consumables, as well as an explanation 

of the result algorithms and method(s) 

of data processing from signal 

acquisition to result assignment; 

(ii) A detailed description of the 

impact of any software, including 

software applications and hardwarebased devices that incorporate software, 

on the device’s functions; 

(iii) Detailed documentation of the 

analytical and clinical studies required 

in paragraphs (b)(3)(iii) and (iv) of this 

section, including the study protocols 

containing descriptions of the test 

methods, prescribed methods of data 

analysis and acceptance criteria, final 

study reports, and data line listings; 

(iv) Detailed documentation of quality 

control procedures, including an 

explanation of how quality control 

materials were selected, the 

recommended frequency of testing, 

methods of control preparation, 

acceptance criteria for performance and 

the results from quality control testing 

performed during the analytical and 

clinical studies required under 

paragraphs (b)(3)(iii) and (iv) of this 

section; 

(v) Detailed documentation of studies 

performed to establish onboard and inuse reagent stability, including the test 

method(s), data analysis plans, 

acceptance criteria, final study reports, 

and data line listings; 

(vi) Detailed documentation of studies 

to establish reagent shelf-life for the 

assay kit and each applicable specimen 

collection and transport device, 

including study protocols containing 

descriptions of the test method(s), data 

analysis plans, and acceptance criteria; 

and 

(vii) Documentation of an appropriate 

end user device training program that 

will be offered as part of efforts to assure 

appropriate conduct of the assay and to 

mitigate the risk associated with false 

results, including failure to use the 

device correctly or correctly interpret 

results. 

Dated: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02368 Filed 2–3–22; 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–0913] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Photoplethysmograph Analysis 

Software for Over-the-Counter Use 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final amendment; final order. 


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