9242 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 

(iii) Accurate positioning and 

alignment of the device to achieve 

fistula creation; and 

(iv) Characterization and verification 

of all dimensions. 

(4) Electrical performance, electrical 

safety, and electromagnetic 

compatibility (EMC) testing must be 

performed for devices with electrical 

components. 

(5) Software verification, validation, 

and hazard analysis must be performed 

for devices that use software. 

(6) All patient-contacting components 

of the device must be demonstrated to 

be biocompatible. 

(7) Performance data must 

demonstrate the sterility of the device 

components intended to be provided 

sterile. 

(8) Performance data must support the 

shelf life of the device by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

identified shelf life. 

(9) Labeling for the device must 

include: 

(i) Instructions for use; 

(ii) Identification of system 

components and compatible devices; 

(iii) Expertise needed for the safe use 

of the device; 

(iv) A detailed summary of the 

clinical testing conducted and the 

patient population studied; and 

(v) A shelf life and storage conditions. 

Dated: February 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03496 Filed 2–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 886 

[Docket No. FDA–2022–N–0104] 

Medical Devices; Ophthalmic Devices; 

Classification of the Electromechanical 

Tear Stimulator 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the electromechanical tear 

stimulator 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 

electromechanical tear stimulator’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. 

DATES: This order is effective February 

18, 2022 . The classification was 

applicable on May 1, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Leonid Livshitz, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1234, Silver Spring, 

MD 20993–0002, 301–796–6975, 

Leonid.Livshitz@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

electromechanical tear stimulator 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 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 

device 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 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

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. 

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 section 513(f)(2)(B)(i) of the 

FD&C Act). As a result, other device 

sponsors do not have to submit a De 

Novo request or premarket approval 

application to market a substantially 

equivalent device (see section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On May 15, 2019, FDA received 

Olympic Ophthalmics, Inc.’s request for 

De Novo classification of the iTEAR100 

Neurostimulator. 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 


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Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 9243 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. The change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

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 May 01, 2020, FDA 

issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 886.5305.1 We have named the 

generic type of device 

electromechanical tear stimulator, and it 

is identified as a non-implantable 

device intended to increase tear 

production via mechanical stimulation. 

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—ELECTROMECHANICAL TEAR STIMULATOR RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Tissue damage due to over stimulation/under stimulation or mechanical injury, device breakage.Clinical performance testing; Non-clinical performance testing; Software 

verification, validation, and hazard analysis; and Labeling. 

Adverse tissue reaction ................................................................ Biocompatibility evaluation, and Labeling. 

Electrical shock or burn ................................................................ Electrical, thermal, and mechanical safety testing; Software verification, validation, and hazard analysis; and Labeling. 

Interference with other devices .................................................... Electromagnetic compatibility (EMC) testing; Software verification, validation, 

and hazard analysis; and Labeling. 

Pain, headache, or discomfort ...................................................... Clinical performance testing, and Non-clinical performance testing. 

Insufficient tear production ........................................................... Clinical performance testing. 

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 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. 3501–3521). The 

collections of information in 21 CFR 

part 860, subpart D, regarding De Novo 

classification 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 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

parts 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 886 

Medical devices, Ophthalmic goods 

and services. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 886 is 

amended as follows: 

PART 886—OPHTHALMIC DEVICES 

■ 1. The authority citation for part 886 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 886.5305 to subpart F to read 

as follows: 

§ 886.5305 Electromechanical tear 

stimulator. 

(a) Identification. An 

electromechanical tear stimulator is a 

non-implantable device intended to 

increase tear production via mechanical 

stimulation. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing under 

anticipated conditions of use must 

evaluate tear production and all adverse 

events, including tissue damage, pain, 

headache, and discomfort. 

(2) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following must 

be conducted: 

(i) An assessment of mechanical 

output specifications, including 

vibration amplitude and frequency, 

pressure and force, and acoustic (noise 

level) properties; 

(ii) Mechanical safety testing to 

validate safeguards related to the 

pressure aspects of the device; and 

(iii) Use life testing. 

(3) Performance data must 

demonstrate the electrical safety, 

thermal safety, and electromagnetic 

compatibility (EMC) of all electrical 

components of the device. 

(4) All patient-contacting components 

of the device must be demonstrated to 

be biocompatible. 

(5) Software verification, validation, 

and hazard analysis must be performed. 


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9244 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 

(6) Physician and patient labeling 

must include: 

(i) A detailed summary of the device’s 

technical parameters; 

(ii) Instructions for use, including an 

explanation of all user-interface 

components and information regarding 

proper device placement; 

(iii) Information related to 

electromagnetic compatibility 

classification; 

(iv) Instructions on how to clean and 

maintain the device; 

(v) A summary of the clinical 

performance testing conducted with the 

device; 

(vi) Language to direct end users to 

contact the device manufacturer and 

MedWatch if they experience any 

adverse events with this device; and 

(vii) Information on how the device 

operates and the typical sensations 

experienced during treatment. 

Dated: February 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03540 Filed 2–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0126] 

RIN 1625–AA00 

Safety Zone; Coast Guard Island, 

Alameda, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

all waters of the Alameda Estuary, from 

surface to bottom, within 250 feet of the 

pier along the southwest side of Coast 

Guard Island in support of a munitions 

transfer on February 20, 2022. The 

safety zone is necessary to protect 

personnel, vessels, and the marine 

environment from the dangers 

associated with live munitions. Entry of 

vessels or persons into this zone is 

prohibited unless specifically 

authorized by the Captain of the Port 

San Francisco. 

DATES: This rule is effective from 8 a.m. 

through 2 p.m. on February 20, 2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2022– 

0126 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email LT Anthony Solares, Sector San 

Francisco Waterways Safety 

Management, U.S. Coast Guard; 

telephone 415–399–3585, email 

Anthony.I.Solares@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

CGC Coast Guard Cutter 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because 

munitions must be transferred for 

operational readiness. It is impracticable 

to publish an NPRM because we must 

establish this safety zone by February 

20, 2022. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable 

because immediate action is needed to 

respond to the potential safety hazards 

associated with the munitions transfer 

near Alameda, CA beginning February 

20, 2022. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034 

(previously 33 U.S.C. 1231). The 

Captain of the Port (COTP) San 

Francisco has determined that potential 

hazards associated with the munitions 

transfer starting February 20, 2022 will 

be a safety concern for anyone within a 

250-foot radius of the pier along the 

southwest side of Coast Guard Island. 

This rule is needed to protect personnel, 

vessels, and the marine environment in 

the navigable waters within the safety 

zone during the munitions transfer. 

IV. Discussion of the Rule 

This rule establishes a safety zone 

from 8 a.m. until 2 p.m. on February 20, 

2022. The safety zone will cover all 

waters of the Alameda Estuary, from 

surface to bottom, within 250 feet of the 

pier along the southwest side of Coast 

Guard Island. The safety zone is 

necessary to ensure the safety of people, 

vessels, and the marine environment for 

the duration of the munitions transfer. 

No vessel or person will be permitted to 

enter the safety zone without obtaining 

permission from the COTP or a 

designated representative. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive Orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive Orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This rule has not been designated a 

‘‘significant regulatory action,’’ under 

Executive Order 12866. Accordingly, 

this rule has not been reviewed by the 

Office of Management and Budget 

(OMB). 

This regulatory action determination 

is based on the size, location, duration, 

and time-of-day of the safety zone. 

Vessel traffic will be able to safely 

transit around this safety zone which 

would impact a small designated area of 

the Alameda Estuary for only six hours. 

The Coast Guard will issue a Broadcast 

Notice to Mariners via VHF–FM marine 

channel 16 about the zone, and the rule 

would allow vessels to seek permission 

to enter the zone. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, 5 U.S.C. 601–612, as amended, 

requires Federal agencies to consider 

the potential impact of regulations on 

small entities during rulemaking. The 

term ‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard certifies under 5 U.S.C. 

605(b) that this rule will not have a 


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