20 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 

confidential with a heading or cover 

note that states ‘‘THIS DOCUMENT 

CONTAINS CONFIDENTIAL 

INFORMATION.’’ The Agency will 

review this copy, including the claimed 

confidential information, in its 

consideration of objections. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your objections and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.fda.gov/ 

regulatoryinformation/dockets/ 

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper objections 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Chelsea Trull, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–6729, 

chelsea.trull@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a document published in the 

Federal Register of May 30, 2017 (82 FR 

24611), FDA announced that we had 

filed a food additive petition (animal 

use) (FAP 2301) submitted by BASF 

Corp., 100 Park Ave., Florham Park, NJ 

07932. The petition proposed that the 

regulations for food additives permitted 

in feed and drinking water of animals be 

amended to provide for the safe use of 

formic acid as a feed acidifying agent in 

complete poultry feeds. 

II. Conclusion 

FDA concludes that the data establish 

the safety and utility of formic acid as 

an acidifying agent in complete poultry 

feeds and that the food additive 

regulations should be amended as set 

forth in this document. This is not a 

significant regulatory action subject to 

Executive Order 12866. 

III. Public Disclosure 

In accordance with § 571.1(h) (21 CFR 

571.1(h)), the petition and documents 

we considered and relied upon in 

reaching our decision to approve the 

petition will be made available for 

public disclosure (see FOR FURTHER

INFORMATION CONTACT). As provided in 

§ 571.1(h), we will delete from the 

documents any materials that are not 

available for public disclosure. 

IV. Environmental Impact 

The Agency has determined under 21 

CFR 25.32(r) 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. 

V. Objections and Hearing Requests 

Any person who will be adversely 

affected by this regulation may file with 

the Dockets Management Staff (see 

ADDRESSES) either electronic or written 

objections. Each objection shall be 

separately numbered, and each 

numbered objection shall specify with 

particularity the provision of the 

regulation to which objection is made 

and the grounds for the objection. Each 

numbered objection on which a hearing 

is requested shall specifically so state. 

Failure to request a hearing for any 

particular objection shall constitute a 

waiver of the right to a hearing on that 

objection. Each numbered objection for 

which a hearing is requested shall 

include a detailed description and 

analysis of the specific factual 

information intended to be presented in 

support of the objection in the event 

that a hearing is held. Failure to include 

such a description and analysis for any 

particular objection shall constitute a 

waiver of the right to a hearing on the 

objection. 

Any objections received in response 

to the regulation may be seen in the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, and will be posted to the docket 

at https://www.regulations.gov. 

List of Subjects in 21 CFR Part 573 

Animal feeds, Food additives. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 573 is amended as follows: 

PART 573—FOOD ADDITIVES 

PERMITTED IN FEED AND DRINKING 

WATER OF ANIMALS 

■ 1. The authority citation for part 573 

continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348. 

■ 2. In § 573.480, revise paragraph (b) 

introductory text and paragraph 

(b)(5)(iii)(B) to read as follows: 

§ 573.480 Formic acid. 

* * * * * 

(b) The additive is used or intended 

for use as a feed acidifying agent, to 

lower the pH, in complete swine and 

poultry feeds at levels not to exceed 1.2 

percent of the complete feed. 

* * * * * 

(5) * * * 

(iii) * * * 

(B) Contact address and telephone 

number for reporting adverse reactions 

or to request a copy of the Safety Data 

Sheet (SDS). 

* * * * * 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28251 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 864 

[Docket No. FDA–2017–N–6780] 

Medical Devices; Hematology and 

Pathology Devices; Classification of 

the Whole Slide Imaging System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the whole slide imaging 

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 whole slide imaging 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. 


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Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 21 

DATES: This order is effective January 2, 

2018. The classification was applicable 

on April 12, 2017. 

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 

whole slide imaging 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 (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 (see 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 (21 U.S.C. 360(k) 

and part 807 (21 CFR part 807). 

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 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 December 1, 2016, Philips Medical 

Systems Nederland B.V. submitted a 

request for De Novo classification of the 

Philips IntelliSite Pathology Solution 

(PIPS). 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 the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on April 12, 2017, FDA 

issued an order to the requester 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 864.3700. We 

have named the generic type of device 

the whole slide imaging system, and it 

is identified as an automated digital 

slide creation, viewing, and 

management system intended as an aid 

to the pathologist to review and 

interpret digital images of surgical 

pathology slides. The system generates 

digital images that would otherwise be 

appropriate for manual visualization by 

conventional light microscopy. 

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—WHOLE SLIDE IMAGING SYSTEM RISKS AND MITIGATION MEASURES

Identified risk Mitigation measures/21 CFR Section 

Inaccurate or missing results leading to, for example, incorrect diagnosis.General controls; 

Special control (1) (21 CFR 864.3700(b)(1)); and, 

Special control (2) (21 CFR 864.3700(b)(2)). 

Delayed results ......................................................................................... General controls; 

Special control (1) (21 CFR 864.3700(b)(1)); and, 

Special control (2) (21 CFR 864.3700(b)(2)). 


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22 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Rules and Regulations 

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. 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 

the guidance document ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ have 

been approved under OMB control 

number 0910–0844; the collections of 

information in 21 CFR part 814, 

subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 

information in part 21 CFR 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 864 

Blood, Medical devices, Packaging 

and containers. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 864 is 

amended as follows: 

PART 864—HEMATOLOGY AND 

PATHOLOGY DEVICES 

■ 1. The authority citation for part 864 

is revised to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 864.3700 to subpart D to read 

as follows: 

§ 864.3700 Whole slide imaging system. 

(a) Identification. The whole slide 

imaging system is an automated digital 

slide creation, viewing, and 

management system intended as an aid 

to the pathologist to review and 

interpret digital images of surgical 

pathology slides. The system generates 

digital images that would otherwise be 

appropriate for manual visualization by 

conventional light microscopy. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include the following 

information: 

(i) The indications for use must 

specify the tissue specimen that is 

intended to be used with the whole 

slide imaging system and the 

components of the system. 

(ii) A detailed description of the 

device and bench testing results at the 

component level, including for the 

following, as appropriate: 

(A) Slide feeder; 

(B) Light source; 

(C) Imaging optics; 

(D) Mechanical scanner movement; 

(E) Digital imaging sensor; 

(F) Image processing software; 

(G) Image composition techniques; 

(H) Image file formats; 

(I) Image review manipulation 

software; 

(J) Computer environment; and 

(K) Display system. 

(iii) Detailed bench testing and results 

at the system level, including for the 

following, as appropriate: 

(A) Color reproducibility; 

(B) Spatial resolution; 

(C) Focusing test; 

(D) Whole slide tissue coverage; 

(E) Stitching error; and 

(F) Turnaround time. 

(iv) Detailed information 

demonstrating the performance 

characteristics of the device, including, 

as appropriate: 

(A) Precision to evaluate intra-system 

and inter-system precision using a 

comprehensive set of clinical specimens 

with defined, clinically relevant 

histologic features from various organ 

systems and diseases. Multiple whole 

slide imaging systems, multiple sites, 

and multiple readers must be included. 

(B) Reproducibility data to evaluate 

inter-site variability using a 

comprehensive set of clinical specimens 

with defined, clinically relevant 

histologic features from various organ 

systems and diseases. Multiple whole 

slide imaging systems, multiple sites, 

and multiple readers must be included. 

(C) Data from a clinical study to 

demonstrate that viewing, reviewing, 

and diagnosing digital images of 

surgical pathology slides prepared from 

tissue slides using the whole slide 

imaging system is non-inferior to using 

an optical microscope. The study 

should evaluate the difference in major 

discordance rates between manual 

digital (MD) and manual optical (MO) 

modalities when compared to the 

reference (e.g., main sign-out diagnosis). 

(D) A detailed human factor 

engineering process must be used to 

evaluate the whole slide imaging system 

user interface(s). 

(2) Labeling compliant with 21 CFR 

809.10(b) must include the following: 

(i) The intended use statement must 

include the information described in 

paragraph (b)(1)(i) of this section, as 

applicable, and a statement that reads, 

‘‘It is the responsibility of a qualified 

pathologist to employ appropriate 

procedures and safeguards to assure the 

validity of the interpretation of images 

obtained using this device.’’ 

(ii) A description of the technical 

studies and the summary of results, 

including those that relate to paragraphs 

(b)(1)(ii) and (iii) of this section, as 

appropriate. 

(iii) A description of the performance 

studies and the summary of results, 

including those that relate to paragraph 

(b)(1)(iv) of this section, as appropriate. 

(iv) A limiting statement that specifies 

that pathologists should exercise 

professional judgment in each clinical 

situation and examine the glass slides 

by conventional microscopy if there is 

doubt about the ability to accurately 

render an interpretation using this 

device alone. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28262 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2017–N–6596] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Irrigating Wound Retractor Device 

AGENCY: Food and Drug Administration, 

HHS. 


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