80 FR 30153 - Medical Devices; Immunology and Microbiology Devices; Classification of Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers From Positive Blood Cultures
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 101 (May 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 101 (May 27, 2015)
| Page Range | 30153-30155 | |
| FR Document | 2015-12741 |
[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)] [Rules and Regulations] [Pages 30153-30155] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12741] [[Page 30153]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2015-N-1072] Medical Devices; Immunology and Microbiology Devices; Classification of Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers From Positive Blood Cultures AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: 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. DATES: This order is effective May 27, 2015. The classification was applicable June 26, 2012. FOR FURTHER INFORMATION CONTACT: 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. 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, July 9, 2012), 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 June 12, 2012, classifying the Verigene[supreg] 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[supreg] 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. In accordance with section 513(f)(2) of the FD&C Act, 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. 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 de novo request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. 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: [[Page 30154]] Table 1--Identified Risks and Required Mitigations ---------------------------------------------------------------------------------------------------------------- Identified risks Required mitigations ---------------------------------------------------------------------------------------------------------------- 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 Sec. 866.3365. II. 510(k) Premarket Notification Following the effective date of this final classification order, any firm submitting a 510(k) premarket notification for this device type will need to comply with the special controls. 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. III. 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 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. V. Clarifications to Special Controls Guidelines 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. 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 21 CFR part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 866.3365 to subpart D to read as follows: Sec. 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 [[Page 30155]] 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. (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 Sec. 866.1(e). Dated: May 20, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-12741 Filed 5-26-15; 8:45 am] BILLING CODE 4164-01-P
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DEPARTMENT OF HEALTH AND equivalent, in accordance with section device that was introduced or delivered
HUMAN SERVICES 513(i) of the FD&C Act, to a predicate for introduction into interstate
device that does not require premarket commerce for commercial distribution
Food and Drug Administration approval. The Agency determines before May 28, 1976, or a device which
whether new devices are substantially was subsequently reclassified into class
21 CFR Part 866 equivalent to predicate devices by I or class II. On June 15, 2012,
[Docket No. FDA–2015–N–1072] means of premarket notification Nanosphere, Inc., submitted a request
procedures in section 510(k) of the for classification of Verigene® Gram
Medical Devices; Immunology and FD&C Act (21 U.S.C. 360(k)) and part Positive Blood Culture Nucleic Acid
Microbiology Devices; Classification of 807 (21 CFR part 807) of the regulations. Test (BC–GP) under section 513(f)(2) of
Multiplex Nucleic Acid Assay for Section 513(f)(2) of the FD&C Act, as the FD&C Act. The manufacturer
Identification of Microorganisms and amended by section 607 of the Food and recommended that the device be
Resistance Markers From Positive Drug Administration Safety and classified into class II.
Blood Cultures Innovation Act (Pub. L. 112–144, July 9, In accordance with section 513(f)(2) of
2012), provides two procedures by the FD&C Act, FDA reviewed the
AGENCY: Food and Drug Administration, which a person may request FDA to request in order to classify the device
HHS. classify a device under the criteria set under the criteria for classification set
ACTION: Final order. forth in section 513(a)(1). Under the first forth in section 513(a)(1) of the FD&C
procedure, the person submits a Act. FDA classifies devices into class II
SUMMARY: The Food and Drug premarket notification under section if general controls by themselves are
Administration (FDA) is classifying 510(k) of the FD&C Act for a device that insufficient to provide reasonable
multiplex nucleic acid assay for has not previously been classified and, assurance of safety and effectiveness,
identification of microorganisms and within 30 days of receiving an order but there is sufficient information to
resistance markers from positive blood classifying the device into class III establish special controls to provide
cultures into class II (special controls). under section 513(f)(1) of the FD&C Act, reasonable assurance of the safety and
The special controls that will apply to the person requests a classification effectiveness of the device for its
this device are identified in this order under section 513(f)(2). Under the intended use. After review of the
and will be part of the codified language second procedure, rather than first information submitted in the de novo
for the multiplex nucleic acid assay for submitting a premarket notification request, FDA determined that the device
identification of microorganisms and under section 510(k) of the FD&C Act can be classified into class II with the
resistance markers from positive blood and then a request for classification establishment of special controls. FDA
cultures. The Agency is classifying the under the first procedure, the person believes these special controls, in
device into class II (special controls) in determines that there is no legally addition to general controls, will
order to provide a reasonable assurance marketed device upon which to base a provide reasonable assurance of the
of safety and effectiveness of the device. determination of substantial safety and effectiveness of the device.
DATES: This order is effective May 27, equivalence and requests a classification The device is assigned the generic
2015. The classification was applicable under section 513(f)(2) of the FD&C Act. name multiplex nucleic acid assay for
June 26, 2012. If the person submits a request to identification of microorganisms and
FOR FURTHER INFORMATION CONTACT: classify the device under this second resistance markers from positive blood
Kimberly J. Sconce, Center for Devices procedure, FDA may decline to cultures, and it is identified as a
and Radiological Health, Food and Drug undertake the classification request if qualitative in vitro device intended to
Administration, 10903 New Hampshire FDA identifies a legally marketed device simultaneously detect and identify
Ave., Bldg. 66, Rm. 5506, Silver Spring, that could provide a reasonable basis for microorganism nucleic acids from blood
MD 20993–0002, 301–796–6679. review of substantial equivalence with cultures that test positive by Gram stain
SUPPLEMENTARY INFORMATION: the device or if FDA determines that the or other microbiological stains. The
device submitted is not of ‘‘low- device detects specific nucleic acid
I. Background moderate risk’’ or that general controls sequences for microorganism
In accordance with section 513(f)(1) of would be inadequate to control the risks identification as well as for
the Federal Food, Drug, and Cosmetic and special controls to mitigate the risks antimicrobial resistance. This device
Act (the FD&C Act) (21 U.S.C. cannot be developed. aids in the diagnosis of bloodstream
360c(f)(1)), devices that were not in In response to a request to classify a infections when used in conjunction
commercial distribution before May 28, device under either procedure provided with other clinical and laboratory
1976 (the date of enactment of the by section 513(f)(2) of the FD&C Act, findings. However, the device does not
Medical Device Amendments of 1976), FDA will classify the device by written replace traditional methods for culture
generally referred to as postamendments order within 120 days. This and susceptibility testing.
devices, are classified automatically by classification will be the initial Multiplex nucleic acid assay for
statute into class III without any FDA classification of the device. identification of microorganisms and
rulemaking process. These devices In accordance with section 513(f)(1) of resistance markers from positive blood
remain in class III and require the FD&C Act, FDA issued an order on cultures is a prescription device.
premarket approval, unless and until June 12, 2012, classifying the Verigene® FDA has identified the following risks
the device is classified or reclassified Gram Positive Blood Culture Nucleic to health associated with this type of
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into class I or II, or FDA issues an order Acid Test (BC–GP) into class III, because device and the measures required to
finding the device to be substantially it was not substantially equivalent to a mitigate these risks in table 1:
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![Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Rules and Regulations 30155
cultures that test positive by Gram stain PART 172—SERVICE OF PROCESS; available in the docket, go to http://
or other microbiological stains. The PRODUCTION OR DISCLOSURE OF www.regulations.gov, type the docket
device detects specific nucleic acid OFFICIAL INFORMATION IN number in the ‘‘SEARCH’’ box and click
sequences for microorganism RESPONSE TO COURT ORDERS, ‘‘SEARCH.’’ Click on ‘‘Open Docket
identification as well as for SUBPOENAS, NOTICES OF Folder’’ on the line associated with this
antimicrobial resistance. This device DEPOSITIONS, REQUESTS FOR rulemaking. You may also visit the
aids in the diagnosis of bloodstream ADMISSIONS, INTERROGATORIES, OR Docket Management Facility in Room
infections when used in conjunction SIMILAR REQUESTS OR DEMANDS IN W12–140 on the ground floor of the
with other clinical and laboratory CONNECTION WITH FEDERAL OR Department of Transportation West
findings. However, the device does not STATE LITIGATION; EXPERT Building, 1200 New Jersey Avenue SE.,
replace traditional methods for culture TESTIMONY Washington, DC 20590, between 9 a.m.
and susceptibility testing. and 5 p.m., Monday through Friday,
(b) Classification. Class II (special ■ 1. The authority citation for part 172 except Federal holidays.
controls). The special control for this continues to read as follows: You may submit comments, identified
device is FDA’s guideline document Authority: 5 U.S.C. 301; 8 U.S.C. 1202(f); by docket number, using any one of the
entitled ‘‘Class II Special Controls 22 U.S.C. 2658, 2664, 3926 following methods:
Guideline: Multiplex Nucleic Acid (1) Federal eRulemaking Portal:
Assay for Identification of § 172.2 [Amended] http://www.regulations.gov.
Microorganisms and Resistance Markers ■ 2. In § 172.2, in paragraph (a), correct (2) Fax: (202) 493–2251.
from Positive Blood Cultures.’’ For the zip code ‘‘20036’’ to read ‘‘20522’’. (3) Mail or Delivery: Docket
availability of the guideline document, Management Facility (M–30), U.S.
Date: May 18, 2015.
see § 866.1(e). Department of Transportation, West
Alice Kottmyer,
Building Ground Floor, Room W12–140,
Dated: May 20, 2015. Attorney Adviser, Office of the Legal Adviser. 1200 New Jersey Avenue SE.,
Leslie Kux, [FR Doc. 2015–12650 Filed 5–26–15; 8:45 am] Washington, DC 20590–0001. Deliveries
Associate Commissioner for Policy. BILLING CODE 4710–08–P accepted between 9 a.m. and 5 p.m.,
[FR Doc. 2015–12741 Filed 5–26–15; 8:45 am] Monday through Friday, except federal
BILLING CODE 4164–01–P holidays. The telephone number is 202–
DEPARTMENT OF HOMELAND 366–9329.
SECURITY See the ‘‘Public Participation and
Request for Comments’’ portion of the
DEPARTMENT OF STATE Coast Guard SUPPLEMENTARY INFORMATION section
below for further instructions on
22 CFR Part 172 33 CFR Part 100 submitting comments. To avoid
[Docket Number USCG–2015–0453] duplication, please use only one of
[Public Notice: 9144] these three methods.
RIN 1625–AA08 FOR FURTHER INFORMATION CONTACT: If
RIN 1400–AD75 Special Local Regulation, Annual you have questions on this rule, call or
Dragon Boat Races, Portland, Oregon email Mr. Ken Lawrenson, Waterways
Service of Process; Address Change; Management Division, MSU Portland,
Correction AGENCY: Coast Guard, DHS. Oregon, Coast Guard; telephone 503–
ACTION: Interim final rule. 240–9319, email MSUPDXWWM@
AGENCY:Department of State. uscg.mil. If you have questions on
Final rule; correcting
ACTION: SUMMARY: The Coast Guard is viewing or submitting material to the
amendment. permanently amending the Annual docket, call Barbara Hairston, Program
Dragon Boat Races, Portland, Oregon Manager, Docket Operations, telephone
SUMMARY: This document contains a special local regulation. This regulation (202) 366–9826.
correction to the address for service of is enforced annually during the Dragon SUPPLEMENTARY INFORMATION:
process on the Department of State Boat Races on the waters of the
(Public Notice 9045). Willamette River between the Table of Acronyms
DATES: Effective May 27, 2015. Hawthorne and Marquam Bridges. This DHS Department of Homeland Security
FOR FURTHER INFORMATION CONTACT: final rule will eliminate inconsistencies FR Federal Register
Alice Kottmyer, Office of the Legal with the event dates and the published NPRM Notice of Proposed Rulemaking
Adviser, Department of State; phone: enforcement period. This will serve to A. Public Participation and Request for
202–647–2318, kottmyeram@state.gov. better inform the public of the regulated Comments
SUPPLEMENTARY INFORMATION: The
race area.
We encourage you to participate in
Department of State published a final DATES: This rule is effective on May 27,
this rulemaking by submitting
rule on March 6, 2015 (80 FR 12081– 2015.
comments and related materials. All
12082), changing the address for service Comments and related material must
comments received will be posted
of process on the Department. This be received by the Coast Guard on or
without change to http://
document corrects the zip code in that before June 26, 2015.
www.regulations.gov and will include
mstockstill on DSK4VPTVN1PROD with RULES
address. Requests for public meetings must be
received by the Coast Guard June 3, any personal information you have
List of Subjects in 22 CFR Part 172 2015. provided.
Service of process. ADDRESSES: Documents mentioned in 1. Submitting Comments
As stated above, title 22, part 172, is this preamble are part of Docket Number If you submit a comment, please
amended by making the following CGD13–06–007. To view documents include the docket number for this
correcting amendment: mentioned in this preamble as being rulemaking, indicate the specific section
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Document Created: 2015-12-15 15:36:07
Document Modified: 2015-12-15 15:36:07
| 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 May 27, 2015. The classification was applicable June 26, 2012. | |
| Contact | 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. | |
| FR Citation | 80 FR 30153 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
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