27702 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 

(2) The 21 CFR 809.10(a) and (b) 

compliant labeling must include the 

following limitations: 

(i) A limiting statement that this 

device is not intended to be used a 

stand-alone device but as an adjunct to 

other clinical information to aid in the 

evaluation of patients who are being 

considered for standard of care 

neuroimaging. 

(ii) A limiting statement that reads ‘‘A 

negative result is generally associated 

with the absence of acute intracranial 

lesions. An appropriate neuroimaging 

method is required for diagnosis of 

acute intracranial lesions.’’ 

(iii) As applicable, a limiting 

statement that reads ‘‘This device is for 

use by laboratory professionals in a 

clinical laboratory setting.’’ 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12760 Filed 6–13–18; 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–2018–N–1862] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Endoscopic Electrosurgical Clip 

Cutting System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the endoscopic 

electrosurgical clip cutting 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 

endoscopic electrosurgical clip cutting 

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 June 14, 

2018. The classification was applicable 

on December 22, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Purva Pandya, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G223, Silver Spring, 

MD 20993–0002, 240–402–9979, 

Purva.Pandya@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

endoscopic electrosurgical clip cutting 

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 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 (21 U.S.C. 

360(k)) and part 807 (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 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. As a 

result, other device sponsors do not 

have to submit a De Novo request or 

PMA in order to market a substantially 

equivalent device (see 21 U.S.C. 360c(i), 

defining ‘‘substantial equivalence’’). 

Instead, sponsors can use the lessburdensome 510(k) process, when 

necessary, to market their device. 

II. De Novo Classification 

On April 11, 2016, Ovesco Endoscopy 

AG submitted a request for De Novo 

classification of the remOVE 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 the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27703 

Therefore, on December 22, 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 876.4310. We 

have named the generic type of device 

endoscopic electrosurgical clip cutting 

system, and it is identified as a 

prescription device that applies 

electrical energy to fragment metallic 

clips, which are devices placed in the 

digestive tract to close gastrointestinal 

perforations, hemorrhages, or perform 

resection. The system includes 

instruments that are then used to 

remove the fragmented clips from the 

digestive tract. 

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—ENDOSCOPIC ELECTROSURGICAL CLIP CUTTING SYSTEM RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Unintended tissue damage (burns, perforations, bleeding) ..... Animal performance testing, Non-clinical performance testing, Electrical and thermal safety testing, Usability testing, and Labeling. 

Electromagnetic interference/Electrical shock ......................... Electromagnetic compatibility testing, Electrical safety testing, and Labeling. 

Adverse tissue reaction ............................................................ Biocompatibility evaluation. 

Infection .................................................................................... Sterilization validation, Shelf life testing, and Labeling. 

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. We encourage 

sponsors to consult with us if they wish 

to use a non-animal testing method they 

believe is suitable, adequate, validated, 

and feasible. We will consider if such an 

alternative method could be assessed for 

equivalency to an animal test method. 

This device is subject to premarket 

notification requirements under section 

510(k) of the FD&C Act. 

At the time of classification, 

endoscopic electrosurgical clip cutting 

systems are for prescription use only. 

Prescription devices are exempt from 

the requirement for adequate directions 

for use for the layperson under section 

502(f)(1) of the FD&C Act and 21 CFR 

801.5, as long as the conditions of 21 

CFR 801.109 are met (referring to 21 

U.S.C. 352(f)(1)). 

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 and 

guidance. 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; 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 876 

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 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGY– 

UROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 876.4310 to subpart E to read 

as follows: 

§ 876.4310 Endoscopic electrosurgical clip 

cutting system. 

(a) Identification. An endoscopic 

electrosurgical clip cutting system is a 

prescription device that applies 

electrical energy to fragment metallic 

clips, which are devices placed in the 

digestive tract to close gastrointestinal 

perforations, hemorrhages, or perform 

resection. The system includes 

instruments that are then used to 

remove the fragmented clips from the 

digestive tract. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Performance bench testing to 

evaluate the functionality (including 

stress, compatibility, usability, and 

reliability) of the device during use; 

(ii) Electrical and thermal safety 

testing; and 

(iii) Electromagnetic compatibility 

testing. 

(2) Animal testing must evaluate 

tissue damage, including thermal 

effects, during the clip removal 

procedure. This testing must also 

evaluate usability and effectiveness of 

the device. 

(3) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible. 

(4) Performance data must 

demonstrate the sterility of the device 

components intended to be provided 

sterile. 

(5) Performance data must support 

shelf life by demonstrating continued 

sterility of the device (or the sterile 

components), package integrity, and 

device functionality over the labeled 

shelf life. 

(6) Labeling of the device must 

include: 

(i) Instructions for use, and 

(ii) A shelf life for single use 

components. 


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27704 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12794 Filed 6–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 149 

[Docket ID: DOD–2017–OS–0050] 

RIN 0790–AJ59 

Policy on Technical Surveillance 

Countermeasures 

AGENCY: Under Secretary of Defense for 

Intelligence, DoD. 

ACTION: Final rule. 

SUMMARY: This final rule removes DoD’s 

regulation concerning the Technical 

Surveillance Countermeasures (TSCM) 

Program. DoD originally determined 

that rulemaking was required based on 

the portion of this part that speaks to 

providing assistance to non-DoD 

agencies. However, this part places no 

burden on other agencies. The 

description of the relationship with 

other agencies is in accordance with 

federal law, and this part is 

unnecessary. Therefore, this part can be 

removed from the CFR. 

DATES: This rule is effective on June 14, 

2018. 

FOR FURTHER INFORMATION CONTACT: 

Richard Davison, 703–697–4850. 

SUPPLEMENTARY INFORMATION: It has been 

determined that publication of this CFR 

part removal for public comment is 

impracticable, unnecessary, and 

contrary to public interest since it is 

based on removing DoD internal 

policies and procedures that are 

publically available on the Department’s 

issuance website. 

This part contains internal DoD 

requirements and thus, does not fiscally 

impact parties outside of DoD. DoD’s 

internal DoD Instruction 5240.05, 

‘‘Technical Surveillance 

Countermeasures (TSCM),’’ remains in 

effect exclusively for the management of 

TSCM in DoD and is available at http:// 

www.esd.whs.mil/Portals/54/ 

Documents/DD/issuances/dodi/524005_

2014.pdf. 

This rule is not significant under 

Executive Order (E.O.) 12866, 

‘‘Regulatory Planning and Review,’’ 

therefore, E.O. 13771, ‘‘Reducing 

Regulation and Controlling Regulatory 

Costs’’ does not apply. 

List of Subjects in 32 CFR Part 149 

Classified information, Investigations. 

PART 149—[REMOVED] 

■ Accordingly, by the authority of 5 

U.S.C. 301, 32 CFR part 149 is removed. 

Dated: June 11, 2018. 

Shelly E. Finke, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2018–12778 Filed 6–13–18; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2018–0438] 

Drawbridge Operation Regulation; 

Newark Bay, Newark, NJ 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the operating 

schedule that governs the Lehigh Valley 

Bridge across the Newark Bay, mile 4.3, 

at Newark, New Jersey. This temporary 

deviation is necessary to allow the 

bridge to remain in the closed-tonavigation position to facilitate repairs. 

DATES: This deviation is effective from 

6 a.m. on July 15, 2018, to 6 p.m. on 

August 6, 2018. 

ADDRESSES: The docket for this 

deviation, USCG–2018–0438 is available 

at http://www.regulations.gov. Type the 

docket number in the ‘‘SEARCH’’ box 

and click ‘‘SEARCH.’’ Click on Open 

Docket Folder on the line associated 

with this deviation. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

deviation, call or email Judy Leung-Yee, 

Bridge Management Specialist, First 

District Bridge Branch, U.S. Coast 

Guard, telephone 212–514–4336, email 

Judy.K.Leung-Yee@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

Consolidated Rail Corporation, the 

owner of the bridge, requested a 

temporary deviation from the normal 

operating schedule to facilitate A-Frame 

sheave bearing repairs. The Lehigh 

Valley Bridge across the Newark Bay, 

mile 4.3, at Newark, New Jersey is a lift 

bridge with a vertical clearance in the 

closed position of 35 feet at mean high 

water and 39 feet at mean low water. 

The existing bridge operating 

regulations are listed at 33 CFR 117.5 

and 117.735. 

Under this temporary deviation, the 

Lehigh Valley Bridge shall remain in the 

closed position from 6 a.m. on July 15, 

2018, to 6 p.m. on July 16, 2018. Should 

inclement weather occur, the following 

rain dates may be used: (1) From 6 a.m. 

on July 22, 2018, to 6 p.m. on July 23, 

2018; (2) from 6 a.m. on July 29, 2018, 

to 6 p.m. on July 30, 2018; or (3) from 

6 a.m. on August 5, 2018, to 6 p.m. on 

August 6, 2018. 

The waterway users are seasonal 

recreational boaters and commercial 

vessels of various sizes. Coordination 

with waterway users indicated no 

objections to this temporary deviation. 

Vessels able to pass under the bridge in 

the closed position may do so at any 

time. The bridge will not be able to open 

for emergencies and there is no 

immediate alternate route for vessels to 

pass. 

The Coast Guard will inform the users 

of the waterways through our Local and 

Broadcast Notices to Mariners of the 

change in operating schedule for the 

bridge so that vessel operators can 

arrange their transits to minimize any 

impact caused by the temporary 

deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: June 11, 2018. 

C.J. Bisignano, 

Supervisory Bridge Management Specialist, 

First Coast Guard District. 

[FR Doc. 2018–12774 Filed 6–13–18; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2018–0526] 

RIN 1625–AA00 

Safety Zone, Festival of the Fish, 

Vermillion River, Vermillion, OH 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

navigable waters within a 420-foot 

radius of the launch site located near 

the mouth of the Vermilion River, 

Vermilion, OH. This safety zone is 


daltland on DSKBBV9HB2PROD with RULES