Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52647 

(6) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Renton, Washington, on October 

30, 2017. 

Jeffrey E. Duven, 

Director, System Oversight Division, Aircraft 

Certification Service. 

[FR Doc. 2017–24166 Filed 11–13–17; 8:45 am] 

BILLING CODE 4910–13–P 

TENNESSEE VALLEY AUTHORITY 

18 CFR Part 1301 

Privacy Act Regulations; Correction 

Correction 

In rule document 2017–24300, 

appearing on pages 51757–51758 in the 

issue of Wednesday, November 8, 2017, 

make the following correction: 

■ On page 51757 in the second column, 

remove Amendatory instruction 2. 

Dates: This correction is effective on 

November 8, 2017. 

[FR Doc. C1–2017–24300 Filed 11–9–17; 4:15 pm] 

BILLING CODE 1301–00–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2017–N–5881] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Automated Indirect 

Immunofluorescence Microscope and 

Software-Assisted System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the automated indirect 

immunofluorescence microscope and 

software-assisted 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 

automated indirect immunofluorescence 

microscope and software-assisted 

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 November 

14, 2017. The classification was 

applicable on April 9, 2015. 

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 

automated indirect immunofluorescence 

microscope and software-assisted 

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. 

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 November 14, 2014, finding the 

NOVA View® Automated Fluorescence 

Microscope 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 December 11, 2014, Inova 

Diagnostics, Inc. submitted a request for 

De Novo classification of the NOVA 


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52648 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 

View® Automated Fluorescence 

Microscope. 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. 

Therefore, on April 9, 2015, 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 866.4750. We 

have named the generic type of device 

automated indirect immunofluorescence 

microscope and software-assisted 

system, and it is identified as a device 

that acquires, analyzes, stores, and 

displays digital images of indirect 

immunofluorescent slides. It is intended 

to be used as an aid in the 

determination of antibody status in 

clinical samples. The device may 

include a fluorescence microscope with 

light source, a motorized microscope 

stage, dedicated instrument controls, a 

camera, a computer, a sample processor, 

or other hardware components. The 

software may include fluorescent signal 

acquisition and processing software, 

data storage and transferring 

mechanisms, or assay specific 

algorithms to suggest results. A trained 

operator must confirm results generated 

with the device. 

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—AUTOMATED INDIRECT IMMUNOFLUORESCENCE MICROSCOPE AND SOFTWARE-ASSISTED SYSTEM RISKS AND

MITIGATION MEASURES

Identified risks Mitigation measures/21 CFR section 

Inaccurate test results that provide false positive or false negative results.Special controls (1), (2), and (3) (21 CFR 866.4750(b)(1); 21 CFR 866.4750(b)(2); and 21 

CFR 866.4750(b)(3)). 

Failure to correctly interpret test results can 

lead to false positive or false negative results.

Special controls (1), (2)(i), (2)(ii)(A), (2)(ii)(B), (2)(iii), and (3) (21 CFR 866.4750(b)(1); 21 CFR 

866.4750(b)(2)(i); 21 CFR 866.4750(b)(2)(ii)(A); 21 CFR 866.4750(b)(2)(ii)(B); 21 CFR 

866.4750(b)(2)(iii); and 21 CFR 866.4750(b)(3)). 

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. This device is 

subject to premarket notification 

requirements under section 510(k) of the 

FD&C Act. 

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 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 § 866.4750 to subpart E to read 

as follows: 

§ 866.4750 Automated indirect 

immunofluorescence microscope and 

software-assisted system. 

(a) Identification. An automated 

indirect immunofluorescence 

microscope and software-assisted 

system is a device that acquires, 

analyzes, stores, and displays digital 

images of indirect immunofluorescent 

slides. It is intended to be used as an aid 

in the determination of antibody status 

in clinical samples. The device may 

include a fluorescence microscope with 

light source, a motorized microscope 

stage, dedicated instrument controls, a 

camera, a computer, a sample processor, 

or other hardware components. The 

software may include fluorescent signal 

acquisition and processing software, 

data storage and transferring 

mechanisms, or assay specific 

algorithms to suggest results. A trained 

operator must confirm results generated 

with the device. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The labeling for the device must 

reference legally marketed assays 

intended for use with the device. 

(2) Premarket notification 

submissions must include the following 

information: 

(i) A detailed description of the 

device that includes: 

(A) A detailed description of 

instrumentation and equipment, and 

illustrations or photographs of nonstandard equipment or methods, if 

applicable; 

(B) Detailed documentation of the 

software, including, but not limited to, 

stand-alone software applications and 

hardware-based devices that incorporate 

software, if applicable; 

(C) A detailed description of 

appropriate internal and external 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52649 

quality controls that are recommended 

or provided. The description must 

identify those control elements that are 

incorporated into the recommended 

testing procedures; 

(D) Detailed description and 

specifications for sample preparation, 

processing, and storage, if applicable; 

(E) Methodology and protocols for 

detecting fluorescence and visualizing 

results; and 

(F) Detailed specification of the 

criteria for test results interpretation and 

reporting. 

(ii) Data demonstrating the 

performance characteristics of the 

device, which must include: 

(A) A comparison study of the results 

obtained with the conventional manual 

method (i.e., reference standard), the 

device, and the reading of the digital 

image without aid of the software, using 

the same set of patient samples for each. 

The study must use a legally marketed 

assay intended for use with the device. 

Patient samples must be from the assayspecific intended use population and 

differential diagnosis population. 

Samples must also cover the assay 

measuring range, if applicable; 

(B) Device clinical performance 

established by comparing device results 

at multiple U.S. sites to the clinical 

diagnostic standard used in the United 

States, using patient samples from the 

assay-specific intended use population 

and the differential diagnosis 

population. For all samples, the 

diagnostic clinical criteria and the 

demographic information must be 

collected and provided. Clinical 

validation must be based on the 

determination of clinical sensitivity and 

clinical specificity using the test results 

(e.g., antibody status based on 

fluorescence to include pattern and 

titer, if applicable) compared to the 

clinical diagnosis of the subject from 

whom the clinical sample was obtained. 

The data must be summarized in tabular 

format comparing the result generated 

by automated, manual, and digital only 

interpretation to the disease status; 

(C) Device precision/reproducibility 

data generated from within-run, 

between-run, between-day, between-lot, 

between-operator, between-instruments, 

between-site, and total precision for 

multiple nonconsecutive days (as 

applicable) using multiple operators, 

multiple instruments and at multiple 

sites. A well-characterized panel of 

patient samples or pools from the 

associated assay specific intended use 

population must be used; 

(D) Device linearity data generated 

from patient samples covering the assay 

measuring range, if applicable; 

(E) Device analytical sensitivity data, 

including limit of blank, limit of 

detection, and limit of quantitation, if 

applicable; 

(F) Device assay specific cutoff, if 

applicable; 

(G) Device analytical specificity data, 

including interference by endogenous 

and exogenous substances, if applicable; 

(H) Device instrument carryover data, 

if applicable; 

(I) Device stability data including realtime stability under various storage 

times and temperatures, if applicable; 

and 

(J) Information on traceability to a 

reference material and description of 

value assignment of calibrators and 

controls, if applicable. 

(iii) Identification of risk mitigation 

elements used by the device, including 

description of all additional procedures, 

methods, and practices, incorporated 

into the directions for use that mitigate 

risks associated with testing. 

(3) Your 21 CFR 809.10 compliant 

labeling must include: 

(i) A warning statement that reads 

‘‘The device is for use by a trained 

operator in a clinical laboratory setting’’; 

(ii) A warning statement that reads 

‘‘All software-aided results must be 

confirmed by the trained operator’’; 

(iii) A warning statement that reads 

‘‘This device is only for use with 

reagents that are indicated for use with 

the device’’; and 

(iv) A description of the protocol and 

performance studies performed in 

accordance with paragraph (b)(2)(ii) of 

this section and a summary of the 

results, if applicable. 

Dated: November 7, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24585 Filed 11–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2017–N–6289] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Prostatic Artery Embolization Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the prostatic artery 

embolization device 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 prostatic artery 

embolization device’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 November 

14, 2017. The classification was 

applicable on June 21, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin Fisher, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G108, Silver Spring, 

MD 20993–0002, 301–796–0245, 

Benjamin.Fisher@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

prostatic artery embolization device 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 (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 


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