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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50074 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 

identify various Streptococcus spp. 

nucleic acids extracted directly from 

clinical specimens. The device detects 

specific nucleic acid sequences for 

organism identification. The 

identification aids in the diagnosis of 

diseases caused by bacteria belonging to 

the genus Streptococcus and provides 

epidemiological information on these 

diseases. Pathogenic streptococci are 

associated with infections, such as sore 

throat, impetigo (an infection 

characterized by small pustules on the 

skin), urinary tract infections, rheumatic 

fever, and kidney disease. 

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—STREPTOCOCCUS SPP. NUCLEIC ACID-BASED ASSAY RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Incorrect identification of a pathogenic microorganism by the device 

can lead to improper patient management.

Special controls (1), (2), (3), (4), (5) and (6) (21 CFR 866.2680(b)(1); 

21 CFR 866.2680(b)(2); 21 CFR 866.2680(b)(3); 21 CFR 

866.2680(b)(4); 21 CFR 866.2680(b)(5); and 21 CFR 

866.2680(b)(6)). 

Failure to correctly interpret test results ................................................... Special control (7) (21 CFR 866.2680(b)(7)). 

Failure to correctly operate the instrument .............................................. Special control (8) (21 CFR 866.2680(b)(8)). 

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). 

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, 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 § 866.2680 to subpart C to read 

as follows: 

§ 866.2680 Streptococcus spp. nucleic 

acid-based assay. 

(a) Identification. A Streptococcus 

spp. nucleic acid-based assay is a 

qualitative in vitro diagnostic device 

intended to simultaneously detect and 

identify various Streptococcus spp. 

nucleic acids extracted directly from 

clinical specimens. The device detects 

specific nucleic acid sequences for 

organism identification. The 

identification aids in the diagnosis of 

diseases caused by bacteria belonging to 

the genus Streptococcus and provides 

epidemiological information on these 

diseases. Pathogenic streptococci are 

associated with infections, such as sore 

throat, impetigo (an infection 

characterized by small pustules on the 

skin), urinary tract infections, rheumatic 

fever, and kidney disease. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include detailed 

device description documentation, 

including the device components, 

ancillary reagents required but not 

provided, and a detailed explanation of 

the methodology including primer/ 

probe sequence, design, and rationale 

for sequence selection. 

(2) Premarket notification 

submissions must include detailed 

documentation from the following 

analytical and clinical performance 

studies: Analytical sensitivity (Limit of 

Detection), reactivity, inclusivity, 

precision, reproducibility, interference, 

cross reactivity, carry-over, and cross 

contamination. 

(3) Premarket notification 

submissions must include detailed 

documentation from a clinical study. 

The study, performed on a study 

population consistent with the intended 

use population, must compare the 

device performance to results obtained 

from well-accepted reference methods. 

(4) Premarket notification 

submissions must include detailed 

documentation for device software, 

including, but not limited to, software 

applications and hardware-based 

devices that incorporate software. 

(5) Premarket notification 

submissions must include database 

implementation methodology, 

construction parameters, and quality 

assurance protocols, as appropriate. 

(6) The device labeling must include 

limitations regarding the need for 

culture confirmation of negative 

specimens, as appropriate. 

(7) A detailed explanation of the 

interpretation of results and acceptance 

criteria must be included in the device’s 

21 CFR 809.10(b)(9) compliant labeling. 

(8) Premarket notification 

submissions must include details on an 

end user device training program that 

will be offered while marketing the 

device, as appropriate. 

Dated: October 25, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–23513 Filed 10–27–17; 8:45 am] 

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