80 FR 67313 - Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 211 (November 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 211 (November 2, 2015)
| Page Range | 67313-67314 | |
| FR Document | 2015-27817 |
[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)] [Rules and Regulations] [Pages 67313-67314] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27817] [[Page 67313]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2015-N-3392] Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective November 2, 2015. The classification was applicable January 14, 2013. FOR FURTHER INFORMATION CONTACT: Andrew Grove, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-796-6198. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on January 03, 2013 automatically classifying the xTAG[supreg] Gastrointestinal Pathogen Panel (GPP) in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, nor to a device that was subsequently reclassified into class I or class II. On January 10, 2013, Luminex Molecular Diagnostics, submitted a request for de novo classification of the xTAG[supreg] GPP under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request for de novo classification in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on January 14, 2013, 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 866.3990 (Sec. 866.3990). Following the effective date of this final classification administrative order, any firm submitting a premarket notification (510(k)) for a gastrointestinal microorganism multiplex nucleic acid- based assay will need to comply with the special controls named in this final administrative order. The device is assigned the generic name gastrointestinal microorganism multiplex nucleic acid-based assay, and it is identified as a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks in table 1: [[Page 67314]] Table 1--Identified Risks and Required Mitigations ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Failure of the device to detect and The FDA document entitled identify a targeted organism when such ``Class II Special Controls organism is present in the specimen Guideline: Gastrointestinal (i.e., false negative result for Microorganism Multiplex presence of organism). Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens,'' which addresses this risk through: Specific device description requirements, performance studies, and labeling. Detection of the targeted microorganism The FDA document entitled when such organism is not present in ``Class II Special Controls the specimen (i.e., false positive Guideline: Gastrointestinal result for presence of organism). Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens,'' which addresses this risk through: Specific device description requirements, performance studies, and labeling. Failure to correctly interpret test The FDA document entitled results. ``Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens,'' which addresses this risk through: Specific device description requirements and labeling. ------------------------------------------------------------------------ FDA believes that the measures set forth in the special controls guideline entitled ``Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens'' are necessary, in addition to general controls, to mitigate the risks to health described in table 1. II. Premarket Notification A gastrointestinal microorganism multiplex nucleic acid-based assay is a prescription device. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this type of device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the gastrointestinal microorganism multiplex nucleic acid-based assay they intend to market. III. Environmental Impact We have determined under 21 CFR 25.34(b) that this action is of 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 administrative 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 21 CFR 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 systems 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 0 1. The authority citation for part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 866.3990 to subpart D to read as follows: Sec. 866.3990 Gastrointestinal microorganism multiplex nucleic acid- based assay. (a) Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. (b) Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: ``Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.'' For availability of the guideline document, see Sec. 866.1(e). Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27817 Filed 10-30-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Rules and Regulations 67313
DEPARTMENT OF HEALTH AND Section 513(f)(2) of the FD&C Act, as request for de novo classification in
HUMAN SERVICES amended by section 607 of the Food and order to classify the device under the
Drug Administration Safety and criteria for classification set forth in
Food and Drug Administration Innovation Act (Pub. L. 112–144), section 513(a)(1) of the FD&C Act. FDA
provides two procedures by which a classifies devices into class II if general
21 CFR Part 866 person may request FDA to classify a controls by themselves are insufficient
device under the criteria set forth in to provide reasonable assurance of
[Docket No. FDA–2015–N–3392] section 513(a)(1). Under the first safety and effectiveness, but there is
procedure, the person submits a sufficient information to establish
Medical Devices; Immunology and
premarket notification under section special controls to provide reasonable
Microbiology Devices; Classification of
510(k) of the FD&C Act for a device that assurance of the safety and effectiveness
Gastrointestinal Microorganism
has not previously been classified and, of the device for its intended use. After
Multiplex Nucleic Acid-Based Assay
within 30 days of receiving an order review of the information submitted in
AGENCY: Food and Drug Administration, classifying the device into class III the request, FDA determined that the
HHS. under section 513(f)(1) of the FD&C Act, device can be classified into class II
ACTION: Final order. the person requests a classification with the establishment of special
under section 513(f)(2). Under the controls. FDA believes these special
SUMMARY: The Food and Drug second procedure, rather than first controls will provide reasonable
Administration (FDA) is classifying a submitting a premarket notification assurance of the safety and effectiveness
gastrointestinal microorganism under section 510(k) of the FD&C Act of the device.
multiplex nucleic acid-based assay into and then a request for classification Therefore, on January 14, 2013, FDA
class II (special controls). The Agency is under the first procedure, the person issued an order to the requestor
classifying the device into class II determines that there is no legally classifying the device into class II. FDA
(special controls) in order to provide a marketed device upon which to base a is codifying the classification of the
reasonable assurance of safety and determination of substantial device by adding 21 CFR 866.3990
effectiveness of the device. equivalence and requests a classification (§ 866.3990).
DATES: This order is effective November
under section 513(f)(2) of the FD&C Act.
Following the effective date of this
2, 2015. The classification was If the person submits a request to
final classification administrative order,
applicable January 14, 2013. classify the device under this second
any firm submitting a premarket
procedure, FDA may decline to
FOR FURTHER INFORMATION CONTACT: notification (510(k)) for a
undertake the classification request if
Andrew Grove, Center for Devices and gastrointestinal microorganism
FDA identifies a legally marketed device
Radiological Health, Food and Drug multiplex nucleic acid-based assay will
that could provide a reasonable basis for
Administration, 10903 New Hampshire need to comply with the special
review of substantial equivalence with
Ave., Bldg. 66, Rm. 5515, Silver Spring, controls named in this final
the device or if FDA determines that the
MD 20993–0002, 301–796–6198. administrative order.
device submitted is not of ‘‘low-
SUPPLEMENTARY INFORMATION: moderate risk’’ or that general controls The device is assigned the generic
would be inadequate to control the risks name gastrointestinal microorganism
I. Background multiplex nucleic acid-based assay, and
and special controls to mitigate the risks
In accordance with section 513(f)(1) of cannot be developed. it is identified as a qualitative in vitro
the Federal Food, Drug, and Cosmetic In response to a request to classify a diagnostic device intended to
Act (the FD&C Act) (21 U.S.C. device under either procedure provided simultaneously detect and identify
360c(f)(1)), devices that were not in by section 513(f)(2) of the FD&C Act, multiple gastrointestinal microbial
commercial distribution before May 28, FDA will classify the device by written nucleic acids extracted from human
1976 (the date of enactment of the order within 120 days. This stool specimens. The device detects
Medical Device Amendments of 1976), classification will be the initial specific nucleic acid sequences for
generally referred to as postamendments classification of the device. organism identification as well as for
devices, are classified automatically by In accordance with section 513(f)(1) of determining the presence of toxin genes.
statute into class III without any FDA the FD&C Act, FDA issued an order on The detection and identification of a
rulemaking process. These devices January 03, 2013 automatically specific gastrointestinal microbial
remain in class III and require classifying the xTAG® Gastrointestinal nucleic acid from individuals exhibiting
premarket approval, unless and until Pathogen Panel (GPP) in class III, signs and symptoms of gastrointestinal
the device is classified or reclassified because it was not substantially infection aids in the diagnosis of
into class I or II, or FDA issues an order equivalent to a device that was gastrointestinal infection when used in
finding the device to be substantially introduced or delivered for introduction conjunction with clinical evaluation
equivalent, in accordance with section into interstate commerce for commercial and other laboratory findings. A
513(i) of the FD&C Act, to a predicate distribution before May 28, 1976, nor to gastrointestinal microorganism
device that does not require premarket a device that was subsequently multiplex nucleic acid-based assay also
approval. The Agency determines reclassified into class I or class II. On aids in the detection and identification
whether new devices are substantially January 10, 2013, Luminex Molecular of acute gastroenteritis in the context of
equivalent to predicate devices by Diagnostics, submitted a request for de outbreaks.
asabaliauskas on DSK5VPTVN1PROD with RULES
means of premarket notification novo classification of the xTAG® GPP FDA has identified the following risks
procedures in section 510(k) of the under section 513(f)(2) of the FD&C Act. to health associated with this type of
FD&C Act (21 U.S.C. 360(k)) and part In accordance with section 513(f)(2) of device and the measures required to
807 (21 CFR part 807) of the regulations. the FD&C Act, FDA reviewed the mitigate these risks in table 1:
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![67314 Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Rules and Regulations
TABLE 1—IDENTIFIED RISKS AND REQUIRED MITIGATIONS
Identified risks Mitigation measures
Failure of the device to detect and identify a targeted organism when The FDA document entitled ‘‘Class II Special Controls Guideline: Gas-
such organism is present in the specimen (i.e., false negative result trointestinal Microorganism Multiplex Nucleic Acid-Based Assays for
for presence of organism). Detection and Identification of Microorganisms and Toxin Genes
from Human Stool Specimens,’’ which addresses this risk through:
Specific device description requirements, performance studies, and
labeling.
Detection of the targeted microorganism when such organism is not The FDA document entitled ‘‘Class II Special Controls Guideline: Gas-
present in the specimen (i.e., false positive result for presence of or- trointestinal Microorganism Multiplex Nucleic Acid-Based Assays for
ganism). Detection and Identification of Microorganisms and Toxin Genes
from Human Stool Specimens,’’ which addresses this risk through:
Specific device description requirements, performance studies, and
labeling.
Failure to correctly interpret test results ................................................... The FDA document entitled ‘‘Class II Special Controls Guideline: Gas-
trointestinal Microorganism Multiplex Nucleic Acid-Based Assays for
Detection and Identification of Microorganisms and Toxin Genes
from Human Stool Specimens,’’ which addresses this risk through:
Specific device description requirements and labeling.
FDA believes that the measures set IV. Paperwork Reduction Act of 1995 § 866.3990 Gastrointestinal
forth in the special controls guideline microorganism multiplex nucleic acid-
entitled ‘‘Class II Special Controls This final administrative order based assay.
Guideline: Gastrointestinal establishes special controls that refer to
(a) Identification. A gastrointestinal
Microorganism Multiplex Nucleic Acid- previously approved collections of
microorganism multiplex nucleic acid-
Based Assays for Detection and information found in other FDA
based assay is a qualitative in vitro
Identification of Microorganisms and regulations. These collections of
diagnostic device intended to
Toxin Genes from Human Stool information are subject to review by the
simultaneously detect and identify
Specimens’’ are necessary, in addition Office of Management and Budget
multiple gastrointestinal microbial
to general controls, to mitigate the risks (OMB) under the Paperwork Reduction
nucleic acids extracted from human
to health described in table 1. Act of 1995 (44 U.S.C. 3501–3520). The
stool specimens. The device detects
II. Premarket Notification collections of information in 21 CFR
specific nucleic acid sequences for
part 807, subpart E, regarding premarket
A gastrointestinal microorganism organism identification as well as for
notification submissions have been
multiplex nucleic acid-based assay is a determining the presence of toxin genes.
approved under OMB control number
prescription device. Section 510(m) of The detection and identification of a
0910–0120; the collections of
the FD&C Act provides that FDA may specific gastrointestinal microbial
information in 21 CFR part 820
exempt a class II device from the nucleic acid from individuals exhibiting
regarding quality systems have been
premarket notification requirements signs and symptoms of gastrointestinal
approved under OMB control number
under section 510(k) of the FD&C Act if infection aids in the diagnosis of
0910–0073; and the collections of
FDA determines that premarket gastrointestinal infection when used in
notification is not necessary to provide information in 21 CFR parts 801 and
conjunction with clinical evaluation
reasonable assurance of the safety and 809 regarding labeling have been
and other laboratory findings. A
effectiveness of the device. For this type approved under OMB control number
gastrointestinal microorganism
of device, FDA has determined that 0910–0485.
multiplex nucleic acid-based assay also
premarket notification is necessary to List of Subjects in 21 CFR Part 866 aids in the detection and identification
provide reasonable assurance of the of acute gastroenteritis in the context of
safety and effectiveness of the device. Biologics, Laboratories, Medical outbreaks.
Therefore, this type of device is not devices.
exempt from premarket notification (b) Classification. Class II (special
requirements. Persons who intend to Therefore, under the Federal Food, controls). The special controls are set
market this type of device must submit Drug, and Cosmetic Act and under forth in FDA’s guideline document
to FDA a premarket notification, prior to authority delegated to the Commissioner entitled: ‘‘Class II Special Controls
marketing the device, which contains of Food and Drugs, 21 CFR part 866 is Guideline: Gastrointestinal
information about the gastrointestinal amended as follows: Microorganism Multiplex Nucleic Acid-
microorganism multiplex nucleic acid- Based Assays for Detection and
based assay they intend to market. PART 866—IMMUNOLOGY AND Identification of Microorganisms and
MICROBIOLOGY DEVICES Toxin Genes from Human Stool
III. Environmental Impact
Specimens.’’ For availability of the
asabaliauskas on DSK5VPTVN1PROD with RULES
We have determined under 21 CFR ■ 1. The authority citation for part 866 guideline document, see § 866.1(e).
25.34(b) that this action is of type that continues to read as follows:
Dated: October 27, 2015.
does not individually or cumulatively Authority: 21 U.S.C. 351, 360, 360c, 360e,
have a significant effect on the human Leslie Kux,
360j, 371.
environment. Therefore, neither an Associate Commissioner for Policy.
environmental assessment nor an ■ 2. Add § 866.3990 to subpart D to read [FR Doc. 2015–27817 Filed 10–30–15; 8:45 am]
environmental impact statement is as follows: BILLING CODE 4164–01–P
required.
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Document Created: 2018-03-01 11:30:20
Document Modified: 2018-03-01 11:30:20
| 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 November 2, 2015. The classification was applicable January 14, 2013. | |
| Contact | Andrew Grove, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301-796-6198. | |
| FR Citation | 80 FR 67313 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
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