49100 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations 

offered as part of your efforts to mitigate 

the risk of failure to correctly operate 

the instrument. 

(7) A detailed explanation of the 

interpretation of results and acceptance 

criteria must be included in the device’s 

21 CFR 809.10(b)(9) compliant labeling, 

and a detailed explanation of the 

interpretation of the limitations of the 

samples (e.g., collected on day of 

diagnosis) must be included in the 

device’s 21 CFR 809.10(b)(10) compliant 

labeling. 

Dated: October 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22994 Filed 10–23–17; 8:45 am] 

BILLING CODE 4164–01–P 

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, 

steven.tjoe@fda.hhs.gov. 

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, bioMe ́rieux, Inc. 

submitted a request for De Novo 

classification of the Vitek® 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. 


pmangrum on DSK3GDR082PROD with RULES
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations 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 pathogenic microorganism can lead to improper patient management.(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. 

Failure to correctly interpret test results ................................................... (1) 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. 

Failure to correctly operate the instrument .............................................. (1) 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. 

(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 

■ 1. The authority citation for part 866 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 866.3361 to subpart D to read 

as follows: 

§ 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 hardwarebased 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. 


pmangrum on DSK3GDR082PROD with RULES
49102 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations 

(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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2017–N–5651] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Zinc Transporter 8 Autoantibody 

Immunological Test System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the zinc transporter 8 

autoantibody immunological test system 

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 

zinc transporter 8 autoantibody 

immunological test system’s 

classification. We are taking this action 

because we have determined that 

classifying the device into class II 

(special controls) will provide a 

reasonable assurance of safety and 

effectiveness of the device. We believe 

this action will also enhance patients’ 

access to beneficial innovative devices, 

in part by reducing regulatory burdens. 

DATES: This order is effective October 

24, 2017. The classification was 

applicable on August 20, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Steven Tjoe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4550, Silver Spring, 

MD 20993–0002, 301–796–5866, 

steven.tjoe@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

zinc transporter 8 autoantibody 

immunological test system 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 (21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

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 is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act (21 

U.S.C. 360c(a)(1)). Although the device 

was automatically 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 

For this device, FDA issued an order 

on May 21, 2014, finding the KRONUS 

Zinc Transporter 8 Autoantibody 

(ZnT8Ab) ELISA Assay not substantially 

equivalent to a predicate not subject to 

PMA. Thus, the device remained in 

class III in accordance with section 

513(f)(1) of the FD&C Act when we 

issued the order. 

On June 16, 2014, KRONUS Market 

Development Associates, Inc., submitted 

a request for De Novo classification of 

the KRONUS Zinc Transporter 8 

Autoantibody (ZnT8Ab) ELISA Assay. 

FDA reviewed the request in order to 

classify the device under the criteria for 

classification set forth in section 

513(a)(1) of the FD&C Act. We classify 

devices into class II if general controls 

by themselves are insufficient to 

provide reasonable assurance of safety 

and effectiveness, but there is sufficient 

information to establish special controls 

that, in combination with the general 

controls, provide reasonable assurance 

of the safety and effectiveness of the 

device for its intended use (see 21 

U.S.C. 360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 


pmangrum on DSK3GDR082PROD with RULES