[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50073-50074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23513]


-----------------------------------------------------------------------

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 Acid-Based 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, 
[email protected].

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

[[Page 50074]]

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            Special controls (1), (2), (3),
 pathogenic microorganism by the device   (4), (5) and (6) (21 CFR
 can lead to improper patient             866.2680(b)(1); 21 CFR
 management.                              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      Special control (7) (21 CFR
 results.                                 866.2680(b)(7)).
Failure to correctly operate the         Special control (8) (21 CFR
 instrument.                              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

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  866.2680 to subpart C to read as follows:


Sec.  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]
 BILLING CODE 4164-01-P