82 FR 50073 - Medical Devices; Immunology and Microbiology Devices; Classification of the Streptococcus SPP. Nucleic Acid-Based Assay
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 208 (October 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 208 (October 30, 2017)
| Page Range | 50073-50074 | |
| FR Document | 2017-23513 |
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)] [Rules and Regulations] [Pages 50073-50074] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50073
Dated: October 24, 2017. any action by FDA, regardless of the section 513(a)(1) of the FD&C Act (21
Anna K. Abram, level of risk posed by the new device. U.S.C. 360c(a)(1)). Although the device
Deputy Commissioner for Policy, Planning, Any device that was not in commercial was automatically within class III, the
Legislation, and Analysis. distribution before May 28, 1976, is De Novo classification is considered to
[FR Doc. 2017–23491 Filed 10–27–17; 8:45 am] automatically classified as, and remains be the initial classification of the device.
BILLING CODE 4164–01–P within, class III and requires premarket We believe this De Novo classification
approval unless and until FDA takes an will enhance patients’ access to
action to classify or reclassify the device beneficial innovation, in part by
DEPARTMENT OF HEALTH AND (see 21 U.S.C. 360c(f)(1)). We refer to reducing regulatory burdens. When FDA
HUMAN SERVICES these devices as ‘‘postamendments classifies a device into class I or II via
devices’’ because they were not in the De Novo process, the device can
Food and Drug Administration commercial distribution prior to the serve as a predicate for future devices of
date of enactment of the Medical Device that type, including for 510(k)s (see 21
21 CFR Part 866 Amendments of 1976, which amended U.S.C. 360c(f)(2)(B)(i)). As a result, other
[Docket No. FDA–2017–N–5719] the Federal Food, Drug, and Cosmetic device sponsors do not have to submit
Act (FD&C Act). a De Novo request or PMA in order to
Medical Devices; Immunology and FDA may take a variety of actions in market a substantially equivalent device
Microbiology Devices; Classification of appropriate circumstances to classify or (see 21 U.S.C. 360c(i), defining
the Streptococcus SPP. Nucleic Acid- reclassify a device into class I or II. We ‘‘substantial equivalence’’). Instead,
Based Assay may issue an order finding a new device sponsors can use the less-burdensome
to be substantially equivalent under 510(k) process, when necessary, to
AGENCY: Food and Drug Administration, section 513(i) of the FD&C Act to a market their device.
HHS. predicate device that does not require
ACTION: Final order. II. De Novo Classification
premarket approval (see 21 U.S.C.
360c(i)). We determine whether a new For this device, FDA issued an order
SUMMARY: The Food and Drug on March 20, 2014, finding the Lyra
device is substantially equivalent to a
Administration (FDA or we) is Direct Strep Assay not substantially
predicate by means of the procedures
classifying the Streptococcus spp. equivalent to a predicate not subject to
for premarket notification under section
nucleic acid-based assay into class II a premarket application approval
510(k) of the FD&C Act and part 807 (21
(special controls). The special controls (PMA). Thus, the device remained in
U.S.C. 360(k) and 21 CFR part 807,
that apply to the device type are class III in accordance with section
respectively).
identified in this order and will be part FDA may also classify a device 513(f)(1) of the FD&C Act when we
of the codified language for the through ‘‘De Novo’’ classification, a issued the order.
Streptococcus spp. nucleic acid-based common name for the process On March 28, 2014, Quidel Corp.
assay’s classification. We are taking this authorized under section 513(f)(2) of the submitted a request for De Novo
action because we have determined that FD&C Act (21 U.S.C. 360c(f)(2)). Section classification of the Lyra Direct Strep
classifying the device into class II 207 of the Food and Drug Assay. FDA reviewed the request in
(special controls) will provide a Administration Modernization Act of order to classify the device under the
reasonable assurance of safety and 1997 established the first procedure for criteria for classification set forth in
effectiveness of the device. We believe De Novo classification (Pub. L. 105– section 513(a)(1) of the FD&C Act. We
this action will also enhance patients’ 115). Section 607 of the Food and Drug classify devices into class II if general
access to beneficial innovative devices, Administration Safety and Innovation controls by themselves are insufficient
in part by reducing regulatory burdens. Act modified the De Novo application to provide reasonable assurance of
DATES: This order is effective October process by adding a second procedure safety and effectiveness, but there is
30, 2017. The classification was (Pub. L. 112–144). A device sponsor sufficient information to establish
applicable on April 16, 2014. may utilize either procedure for De special controls that, in combination
FOR FURTHER INFORMATION CONTACT: Novo classification. with the general controls, provide
Steven Tjoe, Center for Devices and Under the first procedure, the person reasonable assurance of the safety and
Radiological Health, Food and Drug submits a 510(k) for a device that has effectiveness of the device for its
Administration, 10903 New Hampshire not previously been classified. After intended use (see 21 U.S.C.
Ave., Bldg. 66, Rm. 4550, Silver Spring, receiving an order from FDA classifying 360c(a)(1)(B)). After review of the
MD 20993–0002, 301–796–5866, the device into class III under section information submitted in the request,
steven.tjoe@fda.hhs.gov. 513(f)(1) of the FD&C Act, the person we determined that the device can be
SUPPLEMENTARY INFORMATION: then requests a classification under classified into class II with the
section 513(f)(2). establishment of special controls. FDA
I. Background Under the second procedure, rather has determined that these special
Upon request, FDA has classified the than first submitting a 510(k) and then controls, in addition to general controls,
Streptococcus spp. nucleic acid-based a request for classification, if the person will provide reasonable assurance of the
assay as class II (special controls), determines that there is no legally safety and effectiveness of the device.
which we have determined will provide marketed device upon which to base a Therefore, on April 16, 2014, FDA
a reasonable assurance of safety and determination of substantial issued an order to the requestor
effectiveness. In addition, we believe equivalence, that person requests a classifying the device into class II. FDA
is codifying the classification of the
nlaroche on DSK9F9SC42PROD with RULES
this action will enhance patients’ access classification under section 513(f)(2) of
to beneficial innovation, in part by the FD&C Act. device by adding 21 CFR 866.2680. We
reducing regulatory burdens by placing Under either procedure for De Novo have named the generic type of device
the device into a lower device class than classification, FDA is required to Streptococcus spp. nucleic acid-based
the automatic class III assignment. classify the device by written order assay, and it is identified as a qualitative
The automatic assignment of class III within 120 days. The classification will in vitro diagnostic device that is
occurs by operation of law and without be according to the criteria under 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. the genus Streptococcus and provides skin), urinary tract infections, rheumatic
nucleic acids extracted directly from epidemiological information on these fever, and kidney disease.
clinical specimens. The device detects diseases. Pathogenic streptococci are FDA has identified the following risks
specific nucleic acid sequences for associated with infections, such as sore to health associated specifically with
organism identification. The throat, impetigo (an infection this type of device and the measures
identification aids in the diagnosis of characterized by small pustules on the required to mitigate these risks in
diseases caused by bacteria belonging to 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 Special controls (1), (2), (3), (4), (5) and (6) (21 CFR 866.2680(b)(1);
can lead to improper patient management. 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 authority delegated to the Commissioner documentation from the following
controls, in combination with the of Food and Drugs, 21 CFR part 866 is analytical and clinical performance
general controls, address these risks to amended as follows: studies: Analytical sensitivity (Limit of
health and provide reasonable assurance Detection), reactivity, inclusivity,
of safety and effectiveness. In order for PART 866—IMMUNOLOGY AND precision, reproducibility, interference,
a device to fall within this classification, MICROBIOLOGY DEVICES cross reactivity, carry-over, and cross
and thus avoid automatic classification contamination.
in class III, it would have to comply ■ 1. The authority citation for part 866
with the special controls named in this continues to read as follows: (3) Premarket notification
final order. The necessary special Authority: 21 U.S.C. 351, 360, 360c, 360e, submissions must include detailed
controls appear in the regulation 360j, 360l, 371. documentation from a clinical study.
codified by this order. This device is The study, performed on a study
■ 2. Add § 866.2680 to subpart C to read population consistent with the intended
subject to premarket notification as follows:
requirements under section 510(k). use population, must compare the
§ 866.2680 Streptococcus spp. nucleic device performance to results obtained
III. Analysis of Environmental Impact acid-based assay. from well-accepted reference methods.
The Agency has determined under 21 (a) Identification. A Streptococcus (4) Premarket notification
CFR 25.34(b) that this action is of a type spp. nucleic acid-based assay is a submissions must include detailed
that does not individually or qualitative in vitro diagnostic device documentation for device software,
cumulatively have a significant effect on intended to simultaneously detect and including, but not limited to, software
the human environment. Therefore, identify various Streptococcus spp. applications and hardware-based
neither an environmental assessment nucleic acids extracted directly from devices that incorporate software.
nor an environmental impact statement clinical specimens. The device detects
is required. specific nucleic acid sequences for (5) Premarket notification
organism identification. The submissions must include database
IV. Paperwork Reduction Act of 1995 implementation methodology,
identification aids in the diagnosis of
This final order establishes special diseases caused by bacteria belonging to construction parameters, and quality
controls that refer to previously the genus Streptococcus and provides assurance protocols, as appropriate.
approved collections of information epidemiological information on these (6) The device labeling must include
found in other FDA regulations. These diseases. Pathogenic streptococci are limitations regarding the need for
collections of information are subject to associated with infections, such as sore culture confirmation of negative
review by the Office of Management and throat, impetigo (an infection specimens, as appropriate.
Budget (OMB) under the Paperwork characterized by small pustules on the
Reduction Act of 1995 (44 U.S.C. 3501– skin), urinary tract infections, rheumatic (7) A detailed explanation of the
3520). The collections of information in fever, and kidney disease. interpretation of results and acceptance
part 807, subpart E, regarding premarket (b) Classification. Class II (special criteria must be included in the device’s
notification submissions have been controls). The special controls for this 21 CFR 809.10(b)(9) compliant labeling.
approved under OMB control number device are: (8) Premarket notification
0910–0120, and the collections of (1) Premarket notification submissions must include details on an
information in 21 CFR parts 801 and submissions must include detailed end user device training program that
809, regarding labeling have been device description documentation, will be offered while marketing the
approved under OMB control number including the device components, device, as appropriate.
0910–0485.
nlaroche on DSK9F9SC42PROD with RULES
ancillary reagents required but not
Dated: October 25, 2017.
List of Subjects in 21 CFR Part 866 provided, and a detailed explanation of
the methodology including primer/ Lauren Silvis,
Biologics, Laboratories, Medical probe sequence, design, and rationale Chief of Staff.
devices. for sequence selection. [FR Doc. 2017–23513 Filed 10–27–17; 8:45 am]
Therefore, under the Federal Food, (2) Premarket notification BILLING CODE 4164–01–P
Drug, and Cosmetic Act and under submissions must include detailed
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Document Created: 2017-10-28 00:29:03
Document Modified: 2017-10-28 00:29:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective October 30, 2017. The classification was applicable on April 16, 2014. | |
| 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] | |
| FR Citation | 82 FR 50073 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
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