82 FR 49100 - Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 204 (October 24, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 204 (October 24, 2017)
| Page Range | 49100-49102 | |
| FR Document | 2017-23022 |
[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)] [Rules and Regulations] [Pages 49100-49102] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23022] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2017-N-5290] Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the mass spectrometer system for clinical use for the identification of microorganisms 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 mass spectrometer system for clinical use for the identification of microorganisms' 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 24, 2017. The classification was applicable on August 21, 2013. 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 mass spectrometer system for clinical use for the identification of microorganisms 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 (the 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. 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 shall 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. Although the device was automatically placed 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 premarket approval application (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 On January 3, 2013, bioM[eacute]rieux, Inc. submitted a request for De Novo classification of the Vitek[supreg] MS. 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. [[Page 49101]] Therefore, on August 21, 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 866.3361. We have named the generic type of device mass spectrometer system for clinical use for the identification of microorganisms, and it is identified as a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a spectral database. The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. 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--Mass Spectrometer System for Clinical Use for the Identification of Microorganisms Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Incorrect identification of a (1) Premarket notification pathogenic microorganism can lead to submissions must include improper patient management. detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software. (2) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols. Failure to correctly interpret test (1) A detailed explanation of results. the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling. Failure to correctly operate the (1) As part of the risk instrument. management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument. (2) Premarket notification submissions must include details on the appropriate end user device training program that will be offered while marketing the device. ------------------------------------------------------------------------ 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. The 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, the collections of information in 21 CFR part 820 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, 360l, 371. 0 2. Add Sec. 866.3361 to subpart D to read as follows: Sec. 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms. (a) Identification. A mass spectrometer system for clinical use for the identification of microorganisms is a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a spectral database. The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. (b) Classification. Class II (special controls). The special controls for this device are: (1) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software. (2) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols. (3) 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. (4) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument. [[Page 49102]] (5) Premarket notification submissions must include details on the appropriate end user device training program that will be offered while marketing the device. Dated: October 19, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-23022 Filed 10-23-17; 8:45 am] BILLING CODE 4164-01-P
![49100 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations
offered as part of your efforts to mitigate MD 20993–0002, 301–796–5866, receiving an order from FDA classifying
the risk of failure to correctly operate steven.tjoe@fda.hhs.gov. the device into class III under section
the instrument. SUPPLEMENTARY INFORMATION: 513(f)(1) of the FD&C Act, the person
(7) A detailed explanation of the then requests a classification under
interpretation of results and acceptance I. Background section 513(f)(2).
criteria must be included in the device’s Upon request, FDA has classified the Under the second procedure, rather
21 CFR 809.10(b)(9) compliant labeling, mass spectrometer system for clinical than first submitting a 510(k) and then
and a detailed explanation of the use for the identification of a request for classification, if the person
interpretation of the limitations of the microorganisms as class II (special determines that there is no legally
samples (e.g., collected on day of controls), which we have determined marketed device upon which to base a
diagnosis) must be included in the will provide a reasonable assurance of determination of substantial
device’s 21 CFR 809.10(b)(10) compliant safety and effectiveness. In addition, we equivalence, that person requests a
labeling. believe this action will enhance classification under section 513(f)(2) of
patients’ access to beneficial innovation, the FD&C Act.
Dated: October 18, 2017.
in part by reducing regulatory burdens Under either procedure for De Novo
Leslie Kux, classification, FDA shall classify the
by placing the device into a lower
Associate Commissioner for Policy. device class than the automatic class III device by written order within 120 days.
[FR Doc. 2017–22994 Filed 10–23–17; 8:45 am] assignment. The classification will be according to
BILLING CODE 4164–01–P The automatic assignment of class III the criteria under section 513(a)(1) of
occurs by operation of law and without the FD&C Act. Although the device was
any action by FDA, regardless of the automatically placed within class III,
DEPARTMENT OF HEALTH AND level of risk posed by the new device. the De Novo classification is considered
HUMAN SERVICES Any device that was not in commercial to be the initial classification of the
distribution before May 28, 1976, is device.
Food and Drug Administration automatically classified as, and remains We believe this De Novo classification
within, class III and requires premarket will enhance patients’ access to
21 CFR Part 866 approval unless and until FDA takes an beneficial innovation, in part by
action to classify or reclassify the device reducing regulatory burdens. When FDA
[Docket No. FDA–2017–N–5290] (see 21 U.S.C. 360c(f)(1)). We refer to classifies a device into class I or II via
these devices as ‘‘postamendments the De Novo process, the device can
Medical Devices; Immunology and devices’’ because they were not in serve as a predicate for future devices of
Microbiology Devices; Classification of commercial distribution prior to the that type, including for 510(k)s (see 21
the Mass Spectrometer System for date of enactment of the Medical Device U.S.C. 360c(f)(2)(B)(i)). As a result, other
Clinical Use for the Identification of Amendments of 1976, which amended device sponsors do not have to submit
Microorganisms the Federal Food, Drug, and Cosmetic a De Novo request or premarket
AGENCY: Food and Drug Administration, Act (the FD&C Act). approval application (PMA) in order to
HHS. FDA may take a variety of actions in market a substantially equivalent device
appropriate circumstances to classify or (see 21 U.S.C. 360c(i), defining
ACTION: Final order. reclassify a device into class I or II. We ‘‘substantial equivalence’’). Instead,
SUMMARY: The Food and Drug may issue an order finding a new device sponsors can use the less-burdensome
Administration (FDA or we) is to be substantially equivalent under 510(k) process, when necessary, to
classifying the mass spectrometer section 513(i) of the FD&C Act to a market their device.
system for clinical use for the predicate device that does not require
II. De Novo Classification
identification of microorganisms into premarket approval (see 21 U.S.C.
360c(i)). We determine whether a new On January 3, 2013, bioMérieux, Inc.
class II (special controls). The special submitted a request for De Novo
controls that apply to the device type device is substantially equivalent to a
predicate by means of the procedures classification of the Vitek® MS. FDA
are identified in this order and will be reviewed the request in order to classify
part of the codified language for the for premarket notification under section
510(k) of the FD&C Act and part 807 (21 the device under the criteria for
mass spectrometer system for clinical classification set forth in section
use for the identification of U.S.C. 360(k) and 21 CFR part 807,
respectively). 513(a)(1) of the FD&C Act. We classify
microorganisms’ classification. We are devices into class II if general controls
FDA may also classify a device
taking this action because we have by themselves are insufficient to
through ‘‘De Novo’’ classification, a
determined that classifying the device provide reasonable assurance of safety
common name for the process
into class II (special controls) will and effectiveness, but there is sufficient
authorized under section 513(f)(2) of the
provide a reasonable assurance of safety information to establish special controls
FD&C Act. Section 207 of the Food and
and effectiveness of the device. We that, in combination with the general
Drug Administration Modernization Act
believe this action will also enhance controls, provide reasonable assurance
of 1997 established the first procedure
patients’ access to beneficial innovative of the safety and effectiveness of the
for De Novo classification (Pub. L. 105–
devices, in part by reducing regulatory device for its intended use (see 21
115). Section 607 of the Food and Drug
burdens. U.S.C. 360c(a)(1)(B)). After review of the
Administration Safety and Innovation
DATES: This order is effective October Act modified the De Novo application information submitted in the request,
pmangrum on DSK3GDR082PROD with RULES
24, 2017. The classification was process by adding a second procedure we determined that the device can be
applicable on August 21, 2013. (Pub. L. 112–144). A device sponsor classified into class II with the
FOR FURTHER INFORMATION CONTACT: may utilize either procedure for De establishment of special controls. FDA
Steven Tjoe, Center for Devices and Novo classification. has determined that these special
Radiological Health, Food and Drug Under the first procedure, the person controls, in addition to general controls,
Administration, 10903 New Hampshire submits a 510(k) for a device that has will provide reasonable assurance of the
Ave., Bldg. 66, Rm. 4550, Silver Spring, not previously been classified. After safety and effectiveness of the device.
VerDate Sep<11>2014 15:12 Oct 23, 2017 Jkt 244001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\24OCR1.SGM 24OCR1](https://thefederalregister.org/doc/82_FR_49304/page/1.svg)
![49102 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations
(5) Premarket notification enhance patients’ access to beneficial classification under section 513(f)(2) of
submissions must include details on the innovation, in part by reducing the FD&C Act.
appropriate end user device training regulatory burdens by placing the Under either procedure for De Novo
program that will be offered while device into a lower device class than the classification, FDA is required to
marketing the device. automatic class III assignment. classify the device by written order
Dated: October 19, 2017. The automatic assignment of class III within 120 days. The classification will
occurs by operation of law and without be according to the criteria under
Leslie Kux,
any action by FDA, regardless of the section 513(a)(1) of the FD&C Act (21
Associate Commissioner for Policy. U.S.C. 360c(a)(1)). Although the device
level of risk posed by the new device.
[FR Doc. 2017–23022 Filed 10–23–17; 8:45 am] was automatically placed within class
Any device that was not in commercial
BILLING CODE 4164–01–P
distribution before May 28, 1976, is III, the De Novo classification is
automatically classified as, and remains considered to be the initial classification
within, class III and requires premarket of the device.
DEPARTMENT OF HEALTH AND We believe this De Novo classification
approval unless and until FDA takes an
HUMAN SERVICES will enhance patients’ access to
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to beneficial innovation, in part by
Food and Drug Administration reducing regulatory burdens. When FDA
these devices as ‘‘postamendments
devices’’ because they were not in classifies a device into class I or II via
21 CFR Part 866 the De Novo process, the device can
commercial distribution prior to the
[Docket No. FDA–2017–N–5651] date of enactment of the Medical Device serve as a predicate for future devices of
Amendments of 1976, which amended that type, including for 510(k)s (see 21
Medical Devices; Immunology and U.S.C. 360c(f)(2)(B)(i)). As a result, other
the Federal Food, Drug, and Cosmetic
Microbiology Devices; Classification of device sponsors do not have to submit
Act (the FD&C Act).
the Zinc Transporter 8 Autoantibody a De Novo request or premarket
FDA may take a variety of actions in
Immunological Test System approval application (PMA) in order to
appropriate circumstances to classify or
market a substantially equivalent device
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We
(see 21 U.S.C. 360c(i), defining
HHS. may issue an order finding a new device
‘‘substantial equivalence’’). Instead,
ACTION: Final order. to be substantially equivalent under
sponsors can use the less-burdensome
section 513(i) of the FD&C Act (21
SUMMARY: The Food and Drug 510(k) process, when necessary, to
U.S.C. 360c(i)) to a predicate device that
Administration (FDA or we) is market their device.
does not require premarket approval.
classifying the zinc transporter 8 We determine whether a new device is II. De Novo Classification
autoantibody immunological test system substantially equivalent to a predicate For this device, FDA issued an order
into class II (special controls). The by means of the procedures for on May 21, 2014, finding the KRONUS
special controls that apply to the device premarket notification under section Zinc Transporter 8 Autoantibody
type are identified in this order and will 510(k) of the FD&C Act and part 807 (21 (ZnT8Ab) ELISA Assay not substantially
be part of the codified language for the U.S.C. 360(k) and 21 CFR part 807, equivalent to a predicate not subject to
zinc transporter 8 autoantibody respectively). PMA. Thus, the device remained in
immunological test system’s FDA may also classify a device class III in accordance with section
classification. We are taking this action through ‘‘De Novo’’ classification, a 513(f)(1) of the FD&C Act when we
because we have determined that common name for the process issued the order.
classifying the device into class II authorized under section 513(f)(2) of the On June 16, 2014, KRONUS Market
(special controls) will provide a FD&C Act. Section 207 of the Food and Development Associates, Inc., submitted
reasonable assurance of safety and Drug Administration Modernization Act a request for De Novo classification of
effectiveness of the device. We believe of 1997 established the first procedure the KRONUS Zinc Transporter 8
this action will also enhance patients’ for De Novo classification (Pub. L. 105– Autoantibody (ZnT8Ab) ELISA Assay.
access to beneficial innovative devices, 115). Section 607 of the Food and Drug FDA reviewed the request in order to
in part by reducing regulatory burdens. Administration Safety and Innovation classify the device under the criteria for
DATES: This order is effective October Act modified the De Novo application classification set forth in section
24, 2017. The classification was process by adding a second procedure 513(a)(1) of the FD&C Act. We classify
applicable on August 20, 2014. (Pub. L. 112–144). A device sponsor devices into class II if general controls
FOR FURTHER INFORMATION CONTACT: may utilize either procedure for De by themselves are insufficient to
Steven Tjoe, Center for Devices and Novo classification. provide reasonable assurance of safety
Radiological Health, Food and Drug Under the first procedure, the person and effectiveness, but there is sufficient
Administration, 10903 New Hampshire submits a 510(k) for a device that has information to establish special controls
Ave., Bldg. 66, Rm. 4550, Silver Spring, not previously been classified. After that, in combination with the general
MD 20993–0002, 301–796–5866, receiving an order from FDA classifying controls, provide reasonable assurance
steven.tjoe@fda.hhs.gov. the device into class III under section of the safety and effectiveness of the
SUPPLEMENTARY INFORMATION: 513(f)(1) of the FD&C Act, the person device for its intended use (see 21
then requests a classification under U.S.C. 360c(a)(1)(B)). After review of the
I. Background section 513(f)(2). information submitted in the request,
pmangrum on DSK3GDR082PROD with RULES
Upon request, FDA has classified the Under the second procedure, rather we determined that the device can be
zinc transporter 8 autoantibody than first submitting a 510(k) and then classified into class II with the
immunological test system as class II a request for classification, if the person establishment of special controls. FDA
(special controls), which we have determines that there is no legally has determined that these special
determined will provide a reasonable marketed device upon which to base a controls, in addition to general controls,
assurance of safety and effectiveness. In determination of substantial will provide reasonable assurance of the
addition, we believe this action will equivalence, that person requests a safety and effectiveness of the device.
VerDate Sep<11>2014 15:12 Oct 23, 2017 Jkt 244001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\24OCR1.SGM 24OCR1](https://thefederalregister.org/doc/82_FR_49304/page/3.svg)
Document Created: 2018-10-25 10:08:36
Document Modified: 2018-10-25 10:08:36
| 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 24, 2017. The classification was applicable on August 21, 2013. | |
| 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 49100 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR