Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Rules and Regulations 34777 

State party Cultural property Decision No. 

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Peru ......................................................... Archaeological artifacts and ethnological material from Peru ................................. CBP Dec. 22–11. 

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* * * * * 

Robert F. Altneu, 

Director, Regulations & Disclosure Law 

Division, Regulations & Rulings, Office of 

Trade, U.S. Customs and Border Protection. 

Approved: 

Thomas C. West Jr., 

Deputy Assistant Secretary of the Treasury 

for Tax Policy. 

[FR Doc. 2022–12299 Filed 6–7–22; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2021–N–0600] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Intravascular Bleed Monitor 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the intravascular bleed 

monitor 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 intravascular bleed monitor’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 June 8, 

2022. The classification was applicable 

on March 1, 2019. 

FOR FURTHER INFORMATION CONTACT: LT 

Stephen Browning, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2106, Silver Spring, 

MD 20993–0002, 240–402–5241, 

Stephen.Browning@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

intravascular bleed monitor 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 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 

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 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. 

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 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 April 23, 2018, Saranas, Inc. 

submitted a request for De Novo 

classification of the Early Bird Bleed 

Monitoring 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 


khammond on DSKJM1Z7X2PROD with RULES
34778 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Rules and Regulations 

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. 

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 March 1, 2019, 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 870.1345.1 We have named the 

generic type of device intravascular 

bleed monitor, and it is identified as a 

probe, catheter, or catheter introducer 

that measures changes in bioimpedance 

and uses an algorithm to detect or 

monitor progression of potential 

internal bleeding complications. 

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—INTRAVASCULAR BLEED MONITOR RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

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

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

Blood loss, bleeding, hematoma ................................. Human factors testing, Labeling, Animal performance testing, and Non-clinical performance testing. 

Embolization (micro or macro) with transient or permanent ischemia.Human factors testing, Labeling, Animal performance testing, and Non-clinical performance testing. 

Vascular trauma (i.e., dissection, rupture, perforation, 

tear, etc.).

Human factors testing, Labeling, Animal performance testing, and Non-clinical performance testing. 

Electrical shock ............................................................ Electrical safety testing. 

Device failure due to interference with other devices Electromagnetic compatibility (EMC) testing, and Electrical safety testing. 

Device failure due to software malfunction ................. Software verification, validation, and hazard analysis. 

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. 

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 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 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 

part 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 870 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, 21 CFR part 

870 is amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for part 870 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 870.1345 to subpart B to read 

as follows: 

§ 870.1345 Intravascular bleed monitor. 

(a) Identification. An intravascular 

bleed monitor is a probe, catheter, or 

catheter introducer that measures 

changes in bioimpedance and uses an 

algorithm to detect or monitor 

progression of potential internal 

bleeding complications. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) In vivo animal performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use and evaluate the 

following: 

(i) Device performance characteristics; 

(ii) Adverse effects, including gross 

necropsy and histopathology; and 

(iii) Device usability, including device 

preparation, device handling, and user 

interface. 

(2) Non-clinical performance testing 

data must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 


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Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Rules and Regulations 34779 

performance characteristics must be 

tested: 

(i) Tensile testing of joints and 

materials; 

(ii) Mechanical integrity testing; 

(iii) Friction testing; 

(iv) Flush testing; 

(v) Air leakage and liquid leakage 

testing; 

(vi) Latching and unlatching testing; 

(vii) Kink and bend testing; 

(viii) Insertion force testing; 

(ix) Torque testing; 

(x) Corrosion testing; and 

(xi) Dimensional tolerance testing. 

(3) Performance data must support the 

sterility and pyrogenicity of the device 

components intended to be provided 

sterile. 

(4) Performance data must support the 

shelf life of the device by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

identified shelf life. 

(5) The patient contacting 

components of the device must be 

demonstrated to be biocompatible. 

(6) Software verification, validation, 

and hazard analysis must be performed. 

(7) Performance data must 

demonstrate electromagnetic 

compatibility (EMC), electrical safety, 

thermal safety, and mechanical safety. 

(8) Human factors performance 

evaluation must demonstrate that the 

user can correctly use the device, based 

solely on reading the directions for use. 

(9) Labeling must include: 

(i) Instructions for use; 

(ii) A shelf life and storage conditions; 

(iii) Compatible procedures; 

(iv) A sizing table; and 

(v) Quantification of blood detected. 

Dated: June 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12364 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[Docket ID: DoD–2020–HA–0040; and DoD– 

2020–HA–0050] 

RIN 0720–AB81; 0720–AB82; and 0720– 

AB83 

TRICARE Coverage and 

Reimbursement of Certain Services 

Resulting From Temporary Program 

Changes in Response to the COVID–19 

Pandemic; Correction 

AGENCY: Office of the Assistant 

Secretary of Defense for Health Affairs, 

Department of Defense (DoD). 

ACTION: Final rule; correction. 

SUMMARY: The DoD is correcting a final 

rule that appeared in the Federal 

Register on June 1, 2022. The Assistant 

Secretary of Defense for Health Affairs 

issued this final rule related to certain 

provisions of three TRICARE interim 

final rules (IFRs) with request for 

comments issued in 2020 in response to 

the novel coronavirus disease 2019 

(COVID–19) public health emergency 

(PHE). Subsequent to publication of the 

final rule, DoD discovered an error in 

the preamble. This document corrects 

that error. 

DATES: This final rule correction is 

effective on July 1, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Erica Ferron, Defense Health Agency, 

Medical Benefits and Reimbursement 

Section, 303–676–3626 or 

erica.c.ferron.civ@mail.mil. Sharon 

Seelmeyer, Defense Health Agency, 

Medical Benefits and Reimbursement 

Section, 303–676–3690 or 

Sharon.l.seelmeyer.civ@mail.mil, 

Diagnosis Related Groups, Hospital 

Value Based Purchasing, Long Term 

Care Hospitals, and New Technology 

Add-On Payments. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2022–10545 appearing at 87 FR 33001– 

33015 in the Federal Register of 

Wednesday, June 1, 2022, the following 

corrections are made: On page 33007, in 

the third column, in section III.B.a.1, 

correct the first paragraph to read: ‘‘The 

IFR temporarily waived the regulatory 

requirement that an individual be an 

inpatient of a hospital for not less than 

three consecutive calendar days before 

discharge from the hospital (three-day 

prior hospital stay) for coverage of a 

SNF admission for the duration of the 

COVID–19 national emergency, 

consistent with a similar waiver under 

Medicare and TRICARE’s statutory 

requirement to have a SNF benefit like 

Medicare’s. The waiver will terminate 

when the President’s national 

emergency for COVID–19 is 

terminated.’’ 

Dated: June 2, 2022. 

Aaron T. Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2022–12263 Filed 6–7–22; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket Number USCG–2022–0444] 

RIN 1625–AA08 

Special Local Regulation; Lake of the 

Ozarks MM 1–6, Lake Ozark, MO 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a special local regulation 

for the navigable waters of the Lake of 

the Ozarks within a 50-yard radius of all 

vessels participating in a boat parade 

starting at the foremost vessel in the 

World’s Largest Parade marine event 

and extending to the last vessel in the 

parade. This special local regulation 

will follow the vessels until the parade’s 

conclusion. The special local regulation 

is needed to protect personnel, vessels, 

and the marine environment from 

potential hazards created by the 

gathering of participant vessels during 

the Parade. Entry of vessels or persons 

into this zone is prohibited unless 

specifically authorized by the Captain of 

the Port Upper Mississippi River. 

DATES: This rule is effective from 10:30 

a.m. through 1 p.m. June 10, 2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2022– 

0444 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 Lieutenant Commander Stephanie 

Moore, Sector Upper Mississippi River 

Waterways Management Division, U.S. 

Coast Guard; telephone 314–269–2560, 

email Stephanie.R.Moore@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of The Port Sector Upper 

Mississippi River 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 


khammond on DSKJM1Z7X2PROD with RULES