Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50071 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.), as amended by the 

Small Business Regulatory Enforcement 

and Fairness Act of 1996, requires an 

agency to prepare and make available to 

the public a regulatory flexibility 

analysis that describes the effect of a 

proposed rule on small entities (i.e., 

small businesses, small organizations, 

and small governmental jurisdictions) 

when the agency is required to publish 

a general notice of proposed rulemaking 

for a rule. As a notice of proposed 

rulemaking is not necessary for this 

rule, CBP is not required to prepare a 

regulatory flexibility analysis for this 

rule. 

D. Signing Authority 

This regulation is being issued in 

accordance with 19 CFR 0.1(a)(1) 

pertaining to the Secretary of the 

Treasury’s authority (or that of his 

delegate) to approve regulations related 

to certain customs revenue functions. 

List of Subjects in 19 CFR Part 12 

Customs duties and inspection, 

Reporting and recordkeeping 

requirements. 

Amendments to the Regulations 

For the reasons set forth in the 

preamble, part 12 of title 19 of the Code 

of Federal Regulations (19 CFR part 12) 

is amended as set forth below. 

PART 12—SPECIAL CLASSES OF 

MERCHANDISE 

■ 1. The general authority citation for 

part 12 continues to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 

(General Note 3(i), Harmonized Tariff 

Schedule of the United States (HTSUS)), 

1624. 

* * * * * 

■ 2. The specific authority citation for 

§ 12.151 is removed. 

§ 12.151 [Removed and Reserved] 

■ 3. Remove and reserve § 12.151. 

Dated: October 25, 2017. 

Kevin K. McAleenan, 

Acting Commissioner, U.S. Customs and 

Border Protection. 

Approved: 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. 2017–23560 Filed 10–27–17; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 862 

[Docket No. FDA–2017–N–5685] 

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of the Acute Kidney 

Injury Test System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the acute kidney injury test 

system 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 acute kidney injury test system’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, 

in part by reducing regulatory burdens. 

DATES: This order is effective October 

30, 2017. The classification was 

applicable on September 5, 2014. 

FOR FURTHER INFORMATION CONTACT: Seth 

Olson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4561, Silver Spring, 

MD 20993–0002, 301–796–4364, 

Jeremy.Olson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

acute kidney injury test system 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 reducing 

regulatory burdens 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 (the 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 to a 

predicate device that does not require 

premarket approval (see 21 U.S.C. 

360c(i)). We determine whether a new 

device is substantially equivalent to a 

predicate by means of the procedures 

for premarket notification under section 

510(k) of the FD&C Act and part 807 (21 

U.S.C. 360(k) and 21 CFR part 807, 

respectively). 

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 

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, in part by 

reducing regulatory burdens. When FDA 


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50072 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 

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 in order 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 June 5, 2013, Astute Medical, 

Incorporated submitted a request for De 

Novo classification of the 

NEPHROCHECK® Test System. 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 general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on September 5, 2014, FDA 

issued an order to the requestor 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 862.1220. We 

have named the generic type of device 

acute kidney injury test system, and it 

is identified as a device intended to 

measure one or more analytes in human 

samples as an aid in the assessment of 

a patient’s risk for developing acute 

kidney injury. Test results are intended 

to be used in conjunction with other 

clinical and diagnostic findings, 

consistent with professional standards 

of practice, including confirmation by 

alternative methods. 

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—ACUTE KIDNEY INJURY TEST SYSTEM RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures/21 CFR section 

Incorrect interpretation of test results ....................................................... Special controls (1), (2), and (3) (21 CFR 862.1220(b)(1), 21 CFR 

862.1220(b)(2), and 21 CFR 862.1220(b)(3)). 

Incorrect test results ................................................................................. Special control (3) (21 CFR 862.1220(b)(3)). 

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. In order 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– 

3520). 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 21 CFR part 801, regarding 

labeling have been approved under 

OMB control number 0910–0485; and 

the collections of information in 21 CFR 

part 820, regarding the Quality System 

Regulation have been approved under 

OMB control number 0910–0073. 

List of Subjects in 21 CFR Part 862 

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 862 is 

amended as follows: 

PART 862—CLINICAL CHEMISTRY 

AND CLINICAL TOXICOLOGY 

DEVICES 

■ 1. The authority citation for part 862 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 862.1220 to subpart B to read 

as follows: 

§ 862.1220 Acute kidney injury test 

system. 

(a) Identification. An acute kidney 

injury test system is a device that is 

intended to measure one or more 

analytes in human samples as an aid in 

the assessment of a patient’s risk for 

developing acute kidney injury. Test 

results are intended to be used in 

conjunction with other clinical and 

diagnostic findings, consistent with 

professional standards of practice, 

including confirmation by alternative 

methods. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must detail an appropriate 

end user device training program that 

will be offered while marketing the 

device as part of your efforts to mitigate 

the risk of incorrect interpretation of test 

results. 

(2) As part of the risk management 

activities performed as part of your 21 

CFR 820.30 design controls, you must 

document the appropriate end user 

device training program provided in 

your premarket notification submission 

to satisfy special control 21 CFR 

862.1220(b)(1) that will be offered while 

marketing the device as part of your 

efforts to mitigate the risk of incorrect 

interpretation of test results. 

(3) Robust clinical data demonstrating 

the positive predictive value, negative 

predictive value, sensitivity and 

specificity of the test in the intended 

use population must be submitted as 

part of the premarket notification 

submission. 


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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50073 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23491 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2017–N–5719] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Streptococcus SPP. Nucleic AcidBased Assay 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the Streptococcus spp. 

nucleic acid-based assay 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 

Streptococcus spp. nucleic acid-based 

assay’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, 

in part by reducing regulatory burdens. 

DATES: This order is effective October 

30, 2017. The classification was 

applicable on April 16, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Steven Tjoe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4550, Silver Spring, 

MD 20993–0002, 301–796–5866, 

steven.tjoe@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

Streptococcus spp. nucleic acid-based 

assay 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 

reducing regulatory burdens 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 to a 

predicate device that does not require 

premarket approval (see 21 U.S.C. 

360c(i)). We determine whether a new 

device is substantially equivalent to a 

predicate by means of the procedures 

for premarket notification under section 

510(k) of the FD&C Act and part 807 (21 

U.S.C. 360(k) and 21 CFR part 807, 

respectively). 

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

U.S.C. 360c(a)(1)). Although the device 

was automatically 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, in part by 

reducing regulatory burdens. 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 PMA in order 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 

For this device, FDA issued an order 

on March 20, 2014, finding the Lyra 

Direct Strep Assay not substantially 

equivalent to a predicate not subject to 

a premarket application approval 

(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 March 28, 2014, Quidel Corp. 

submitted a request for De Novo 

classification of the Lyra Direct Strep 

Assay. 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 general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on April 16, 2014, FDA 

issued an order to the requestor 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 866.2680. We 

have named the generic type of device 

Streptococcus spp. nucleic acid-based 

assay, and it is identified as a qualitative 

in vitro diagnostic device that is 

intended to simultaneously detect and 


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