600 Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 

Æ Facilities that would qualify as 

secondary activities farms except that 

they pack, package, label, and/or hold 

processed food that consists only of 

RACs that have been dried/dehydrated 

to create a distinct commodity (e.g., 

dried beans); 

Æ Farm mixed-type facilities making 

silage food for animals; 

• Written assurances under the 

‘‘customer provisions’’ in part 117 and 

related rules; 

• Importation of food contact 

substances under the FSVP regulation; 

and 

• Certain human food by-products for 

use as animal food, with regard to 

certain requirements under part 507. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in 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 117 have been approved under 

OMB control number 0910–0751. The 

collections of information in part 507 

have been approved under OMB control 

number 0910–0789. The collections of 

information in 21 CFR part 1, subpart L 

have been approved under OMB control 

number 0910–0752. The collections of 

information in part 112 have been 

approved under OMB control number 

0910–0816. 

II. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/FoodGuidances or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: January 2, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00050 Filed 1–4–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 892 

[Docket No. FDA–2017–N–6539] 

Medical Devices; Radiology Devices; 

Classification of the Absorbable 

Perirectal Spacer 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the absorbable perirectal 

spacer 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 absorbable perirectal spacer’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 January 5, 

2018. The classification was applicable 

on April 1, 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 

absorbable perirectal spacer 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 (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 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 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. 


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Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 601 

II. De Novo Classification 

On October 1, 2014, Augmenix, Inc. 

submitted a request for De Novo 

classification of the SpaceOAR System. 

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 1, 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 892.5725. We 

have named the generic type of device 

absorbable perirectal spacer, and it is 

identified as a device composed of 

biodegradable material that temporarily 

positions the anterior rectal wall away 

from the prostate during radiotherapy 

for prostate cancer with the intent to 

reduce the radiation dose delivered to 

the anterior rectum. The absorbable 

spacer maintains space for the entire 

course of prostate radiotherapy 

treatment and is completely absorbed by 

the patient’s body over time. 

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—ABSORBABLE PERIRECTAL SPACER RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures/21 CFR section 

Device functional failure or the device is unable to maintain space stability during the course of radiation therapy.Special Controls (1)(i) (21 CFR 892.5725(b)(1)(i)), (1)(ii) (21 CFR 

892.5725(b)(1)(ii)), (1)(iv) (21 CFR 892.5725(b)(1)(iv)), and (1)(vi) 

(21 CFR 892.5725(b)(1)(vi)). 

Prolonged or delayed procedure .............................................................. Special Controls (1)(iii) (21 CFR 892.5725(b)(1)(iii)), (1)(iv) (21 CFR 

892.5725(b)(1)(iv)), (2) (21 CFR 892.5725(b)(2)), and (3) (21 CFR 

892.5725(b)(3)). 

Needle penetration and/or spacer material injection into bloodstream, 

bladder, prostate, rectal wall, rectum, or urethra.

Special Controls (1)(iv) (21 CFR 892.5725(b)(1)(iv)), (2) (21 CFR 

892.5725(b)(2)), and (3) (21 CFR 892.5725(b)(3)). 

Incomplete absorption .............................................................................. Special Controls (1)(iii) (21 CFR 892.5725(b)(1)(iii)), (1)(iv) (21 CFR 

892.5725(b)(1)(iv)), and (1)(vii) (21 CFR 892.5725(b)(1)(vii)). 

Infection or local tissue inflammatory reactions ....................................... Special Controls (1)(iv) (21 CFR 892.5725(b)(1)(iv)), (1)(v) (21 CFR 

892.5725(b)(1)(v)), (1)(vi) (21 CFR 892.5725(b)(1)(vi)), (1)(vii) (21 

CFR 892.5725(b)(1)(vii)), and (3) (21 CFR 892.5725(b)(3)). 

Pain or discomfort associated with spacer .............................................. Special Controls (1)(iv) (21 CFR 892.5725(b)(1)(iv)) and (3) (21 CFR 

892.5725(b)(3)). 

Urine retention, bleeding, rectal mucosal damage, ulcers, necrosis, 

constipation, or rectal urgency.

Special Controls (1)(iii) (21 CFR 892.5725(b)(1)(iii)), (1)(iv) (21 CFR 

892.5725(b)(1)(iv)), (1)(vii) (21 CFR 892.5725(b)(1)(vii)), (2) (21 CFR 

892.5725(b)(2)), and (3) (21 CFR 892.5725(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 

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 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in part 820 

have been approved under OMB control 

number 0910–0073; and, the collections 

of information in 21 CFR part 801, 

regarding labeling, have been approved 

under OMB control number 0910–0485. 

List of Subjects in 21 CFR Part 892 

Medical devices, Radiation 

protection, X-rays. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 892 is 

amended as follows: 

PART 892—RADIOLOGY DEVICES 

■ 1. The authority citation for part 892 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 892.5725 to subpart F to read 

as follows: 

§ 892.5725 Absorbable perirectal spacer. 

(a) Identification. An absorbable 

perirectal spacer is composed of 

biodegradable material that temporarily 

positions the anterior rectal wall away 

from the prostate during radiotherapy 

for prostate cancer with the intent to 


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602 Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 

reduce the radiation dose delivered to 

the anterior rectum. The absorbable 

spacer maintains space for the entire 

course of prostate radiotherapy 

treatment and is completely absorbed by 

the patient’s body over time. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The premarket notification 

submission must include methodology 

and results of the following non-clinical 

and clinical performance testing. For all 

clinical investigations used to support 

premarket notification submissions for 

this type of device, line listings of the 

study data must be provided. 

(i) Performance bench testing must 

demonstrate appropriate perirectal 

space creation and maintenance for the 

duration of prostate radiotherapy. 

(ii) Performance bench testing must 

demonstrate that therapeutic radiation 

levels do not alter the performance of 

the device. 

(iii) Performance in vivo testing must 

demonstrate appropriate deployment of 

spacer as indicated in the accompanying 

labeling, and demonstrate appropriate 

expansion and absorption 

characteristics in a clinically relevant 

environment. 

(iv) Clinical study must demonstrate 

appropriate spacer stability and lack of 

migration for the entire course of 

radiotherapy, complete absorption, and 

lack of long term toxicity. 

(v) Sterility testing must demonstrate 

the sterility of the device and the effects 

of the sterilization process on the 

physical characteristics of the spacer. 

(vi) Shelf-life testing must 

demonstrate the stability of the physical 

characteristics of the spacer throughout 

the shelf-life as indicated in the 

accompanying labeling. 

(vii) The device must be demonstrated 

to be biocompatible. 

(2) The risk management activities 

performed as part of the manufacturer’s 

§ 820.30 design controls must document 

an appropriate end user initial training 

program which will be offered as part of 

efforts to mitigate the risk of failure to 

correctly operate the device, including, 

but not limited to, documentation of an 

appropriate end user initial training 

program on the proper spacer 

deployment technique. 

(3) The device labeling must include 

the following: 

(i) A detailed summary of reported or 

observed complications related to the 

use of the device; 

(ii) Appropriate warnings; 

(iii) Detailed instructions for system 

preparations and detailed implant 

procedure instructions; and 

(iv) An expiration date that is 

supported by performance data as 

specified in paragraph (b)(1)(vi) of this 

section. 

Dated: January 2, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00051 Filed 1–4–18; 8:45 am] 

BILLING CODE 4164–01–P 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Parts 300–3, 300–70, 301–10, 

301–70, Appendix C to Chapter 301, 

Parts 302–1, 302–4, and 304–2 

[FTR Amendment 2017–01; FTR Case 2017– 

301; Docket No. 2017–0004, Sequence 1] 

RIN 3090–AJ89 

Federal Travel Regulation; 

Transportation Network Companies 

(TNC), Innovative Mobility Technology 

Companies, and Reporting Travel, 

Transportation, and Relocation Costs 

AGENCY: Office of Government-wide 

Policy (OGP), General Services 

Administration (GSA). 

ACTION: Direct final rule; request for 

comments. 

SUMMARY: GSA is amending the Federal 

Travel Regulation (FTR) by adding 

terms and definitions for ‘‘innovative 

mobility technology company’’, ‘‘taxi’’, 

and ‘‘transportation network company 

(TNC)’’, and designating ‘‘innovative 

mobility technology company’’ and 

‘‘TNC’’ as forms of special conveyances. 

In addition, this direct final rule adds a 

due date by which agencies must report 

travel, transportation, and relocation 

costs and data to GSA. These actions are 

required by the Modernizing 

Government Travel Act. 

DATES: This rule is effective on February 

20, 2018 without further notice, unless 

GSA receives adverse comments by 

February 5, 2018. 

GSA will consider whether these 

comments are significant enough to 

publish a timely withdrawal in the 

Federal Register informing the public 

that this direct final rule will not take 

effect. Please see SUPPLEMENTARY

INFORMATION for more information on 

significant adverse comments. 

ADDRESSES: Submit comments 

identified by FTR Case 2017–301 by any 

of the following methods: 

• Regulations.gov: http://

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

entering ‘‘FTR Case 2017–301’’ under 

the heading ‘‘Enter Keyword or ID’’ and 

selecting ‘‘Search’’. Select the link 

‘‘Submit a Comment’’ that corresponds 

with ‘‘FTR Case 2017–301’’ and follow 

the instructions provided on the screen. 

Please include your name, company 

name (if any), and ‘‘FTR Case 2017– 

301’’ on your attached document. 

• Mail: General Services 

Administration, Regulatory Secretariat 

Division (MVCB), Attn: Lois Mandell, 

1800 F Street NW, Washington, DC 

20405. 

Instructions: Please submit comments 

only and cite ‘‘FTR Case 2017–301’’ in 

all correspondence related to this case. 

All comments received will be posted 

without change to http://

www.regulations.gov, including any 

personal and/or business confidential 

information provided. To confirm 

receipt of your comment(s), please 

check www.regulations.gov 

approximately two to three days after 

submission to verify posting (except 

allow 30 days for posting of comments 

submitted by mail). 

FOR FURTHER INFORMATION CONTACT: For 

clarification of content, contact Mr. Cy 

Greenidge, Program Analyst, Office of 

Government-wide Policy, at 202–219– 

2349 or cy.greenidge@gsa.gov. For more 

information pertaining to status or 

publication schedules, contact the 

Regulatory Secretariat (MVCB), 1800 F 

Street NW, Washington, DC 20405, 202– 

501–4755. Please cite FTR Case 2017– 

301. 

SUPPLEMENTARY INFORMATION: 

A. Public Participation 

GSA is publishing this direct final 

rule without a prior proposed rule 

because this is a noncontroversial action 

required by statute, and GSA anticipates 

no significant adverse comments. 

A significant adverse comment is 

defined as one where the comment 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. In 

determining whether a significant 

adverse comment is sufficient to 

terminate a direct final rulemaking, GSA 

will consider whether the comment 

raises an issue serious enough to 

warrant a substantive response in a 

notice-and-comment process. GSA notes 

that comments that are frivolous, 

insubstantial, or outside the scope of the 

rule would not be considered adverse 

under this procedure. A comment 

recommending a rule change in addition 

to the rule would not be considered a 

significant adverse comment, unless the 

comment states why the rule would be 

ineffective without the additional 


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