Source: https://www.federalregister.gov/documents/2015/05/27/2015-12741/medical-devices-immunology-and-microbiology-devices-classification-of-multiplex-nucleic-acid-assay
Timestamp: 2017-09-21 02:06:47
Document Index: 65412705

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Federal Register :: Medical Devices; Immunology and Microbiology Devices; Classification of Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers From Positive Blood Cultures
Medical Devices; Immunology and Microbiology Devices; Classification of Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers From Positive Blood Cultures
A Rule by the Food and Drug Administration on 05/27/2015
This order is effective May 27, 2015. The classification was applicable June 26, 2012.
80 FR 30153
Docket No. FDA-2015-N-1072
2015-12741
FDA-2015-N-1072
V. Clarifications to Special Controls Guidelines
https://www.federalregister.gov/d/2015-12741 https://www.federalregister.gov/d/2015-12741
Start Preamble Start Printed Page 30153
The Food and Drug Administration (FDA) is classifying multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. 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.
Kimberly J. Sconce, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5506, Silver Spring, MD 20993-0002, 301-796-6679.
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on June 12, 2012, classifying the Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) into 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, or a device which was subsequently reclassified into class I or class II. On June 15, 2012, Nanosphere, Inc., submitted a request for classification of Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II.
The device is assigned the generic name multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures, and it is identified as a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.
Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a prescription device.
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:Start Printed Page 30154
False negative result The FDA document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures,” which addresses this risk through: Device description containing the information specified in the special control guideline, performance characteristics, and labeling.
False positive result The FDA document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures,” which addresses this risk through: Device description containing the information specified in the special control guideline, performance characteristics, and labeling.
Errors in interpretation The FDA document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures,” which addresses this risk through: Device description containing the information specified in the special control guideline, performance characteristics, and labeling.
FDA believes that the measures set forth in the special controls guideline entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures” are necessary, in addition to general controls, to mitigate the risks to health described in table 1.
Therefore, effective June 26, 2012, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding § 866.3365.
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 device type 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 multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures they intend to market.
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 parts 50 and 56 have been approved under OMB control number 0910-0755; 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 parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 812 regarding investigational device exemptions have been approved under OMB control number 0910-0078; 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 regarding Requests for Feedback (“presubmissions”) have been approved under OMB control number 0910-0756.
This special controls guideline reflects changes the Agency is making to clarify its position on the binding nature of special controls. The changes include referring to the document as a “guideline,” as that term is used in section 513(a) of the FD&C Act, which the Secretary has developed and disseminated to provide a reasonable assurance of safety and effectiveness for class II devices, and not a “guidance,” as that term is used in 21 CFR 10.115. The guideline uses mandatory language to emphasize that firms must comply with special controls to legally market their class II devices. The guideline clarifies that firms will need either to: (1) Comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness. These revisions do not represent a change in FDA's position about the binding effect of special controls, but rather are intended to address any possible confusion or misunderstanding.
2. Add § 866.3365 to subpart D to read as follows:
§ 866.3365
Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
(a) Identification. A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood Start Printed Page 30155cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.
(b) Classification. Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).
[FR Doc. 2015-12741 Filed 5-26-15; 8:45 am]