77198 Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 

AIRAC date State City Airport name FDC No. FDC date Procedure name 

30–Nov–23 ..... CT Bridgeport ...... Bridgeport/Sikorsky .......... 3/3119 10/11/23 ILS OR LOC RWY 6, Amdt 10B. 

30–Nov–23 ..... CT Bridgeport ...... Bridgeport/Sikorsky .......... 3/3122 10/11/23 RNAV (GPS) RWY 29, Amdt 2B. 

30–Nov–23 ..... CT Bridgeport ...... Bridgeport/Sikorsky .......... 3/3123 10/11/23 RNAV (GPS) RWY 24, Amdt 1B. 

30–Nov–23 ..... CT Bridgeport ...... Bridgeport/Sikorsky .......... 3/3125 10/11/23 RNAV (GPS) RWY 6, Amdt 1B. 

30–Nov–23 ..... MI Hancock ......... Houghton County Meml ... 3/6218 10/16/23 RNAV (GPS) RWY 25, Amdt 1B. 

30–Nov–23 ..... KS Manhattan ...... Manhattan Rgnl ................ 3/6770 10/19/23 ILS OR LOC RWY 3, Amdt 8. 

30–Nov–23 ..... MA Plymouth ........ Plymouth Muni ................. 3/8906 10/20/23 RNAV (GPS) RWY 33, Amdt 1. 

30–Nov–23 ..... MA Plymouth ........ Plymouth Muni ................. 3/8908 10/20/23 RNAV (GPS) RWY 15, Orig–A. 

[FR Doc. 2023–24660 Filed 11–8–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 864 

[Docket No. FDA–2023–N–4487] 

Medical Devices; Hematology and 

Pathology Devices; Classification of 

the Container System for the 

Processing and Storage of Red Blood 

Cell Components Under Reduced 

Oxygen Conditions 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the container system for the 

processing and storage of Red Blood 

Cell components under reduced oxygen 

conditions 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 classification 

of the container system for the 

processing and storage of Red Blood 

Cell components under reduced oxygen 

conditions. 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 November 

9, 2023. The classification was 

applicable on September 15, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Karen Fikes, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

container system for the processing and 

storage of Red Blood Cell components 

under reduced oxygen conditions as 

class II (special controls), which we 

have determined will provide a 

reasonable assurance of safety and 

effectiveness. 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; (see also 21 CFR part 860, 

subpart D). 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 510(k) process, when necessary, to 

market their device. 

II. De Novo Classification 

On January 5, 2022, FDA received 

Hemanext, Inc.’s request for De Novo 

classification of the Hemanext One. 

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, 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 77199 

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. 

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 September 15, 2023, 

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 864.9115.1 We have named the 

generic type of device container system 

for the processing and storage of Red 

Blood Cell components under reduced 

oxygen conditions, identified as a 

device intended for medical purposes 

that is used to process and store Red 

Blood Cell components and reduce 

oxygen levels in the storage 

environment. 

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—CONTAINER SYSTEM FOR THE PROCESSING AND STORAGE OF RED BLOOD CELL COMPONENTS UNDER

REDUCED OXYGEN CONDITIONS RISKS TO HEALTH AND MITIGATION MEASURES

Identified risks to health Mitigation measures 

Toxicity that can result from contact of the component materials of the device with the red 

blood cells or patient’s body.

Biocompatibility evaluation. 

Toxicity of leached materials, or residual chemical sterilant, when in contact with red blood cells 

or transfused to patient.

Extractables and leachables testing. 

Infection ........................................................................................................................................... Sterilization validation; Endotoxin testing; and 

Container closure evaluation. 

Transfusion of poor quality red blood cells because of inadequate storage conditions or device 

malfunction.

Nonclinical and clinical studies; Shelf-life testing; and Performance testing. 

Blood exposure because of device malfunction ............................................................................. Performance testing. 

Transfusion of poor quality red blood cells due to processing of Red Blood Cells components 

collected from donors with hemoglobin S.

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. 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. 

At the time of classification, container 

system for the processing and storage of 

Red Blood Cell components under 

reduced oxygen conditions is 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 (21 U.S.C. 

352(f)(1)) and 21 CFR 801.5, as long as 

the conditions of 21 CFR 801.109 are 

met. 

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 

part 801, 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 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 864.9115 to subpart J to read 

as follows: 

§ 864.9115 Container system for the 

processing and storage of Red Blood Cell 

components under reduced oxygen 

conditions. 

(a) Identification. A container system 

for the processing and storage of Red 

Blood Cell components under reduced 

oxygen conditions is a device intended 

for medical purposes that is used to 

process and store Red Blood Cell 

components and reduce oxygen levels 

in the storage environment. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 


ddrumheller on DSK120RN23PROD with RULES1
77200 Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 

(1) The intended use of the device 

must specify: 

(i) The Red Blood Cell components 

that can be processed and stored 

including acceptable anticoagulants and 

additive solutions; 

(ii) The hold time after Red Blood Cell 

component collection; 

(iii) The processing capacity (volume) 

of the device; and 

(iv) The storage temperature and 

dating period of processed Red Blood 

Cell components. 

(2) Studies must demonstrate that the 

device is biocompatible and include 

detailed documentation of the 

biocompatibility evaluation. 

(3) Performance testing and 

nonclinical studies must include a 

detailed study of leached materials 

extracted under conditions similar to 

clinical usage of the device, and a 

toxicologic risk assessment of those 

extracted or leached materials. 

(4) Performance testing must support 

sterility of the device and include 

sterilization validation, endotoxin 

testing, and container closure integrity 

evaluation. 

(5) Nonclinical and clinical studies 

must include evaluation of red blood 

cell quality throughout the duration of 

storage based on in vitro and in vivo 

studies, including hemolysis and red 

blood cell survival and recovery. 

(6) Performance studies must include: 

(i) Detailed documentation of 

functional and mechanical testing, 

including evaluation of oxygen and, if 

applicable, carbon dioxide levels during 

Red Blood Cell components storage; and 

(ii) Detailed documentation of device 

shelf-life testing demonstrating 

continued sterility, package integrity, 

and functionality over the identified 

shelf life. 

(7) The labeling must include a 

contraindication against processing Red 

Blood Cell components collected from 

donors with hemoglobin S. 

Dated: November 3, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24717 Filed 11–8–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2023–0783] 

Special Local Regulations; OPA World 

Championships; Gulf of Mexico; 

Englewood, FL 

AGENCY: Coast Guard, DHS. 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

special local regulations for the OPA 

World Championships to provide for the 

safety of life on navigable waterways 

during this event. Our regulation for 

marine events within the Seventh Coast 

Guard District identifies the regulated 

area for this event in Englewood Beach, 

FL. During the enforcement periods, the 

operator of any vessel in the regulated 

area must comply with directions from 

the Patrol Commander or any 

designated representative. 

DATES: The regulations in 33 CFR 

100.703 will be enforced daily from 8 

a.m. until 6 p.m. on November 18, 2023, 

through November 19, 2023, for the 

location identified in Item 8 in table 1 

to § 100.703. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

notification of enforcement, call or 

email Marine Science Technician First 

Class Mara Brown, Sector St. Petersburg 

Prevention Department, Coast Guard; 

telephone 813–228–2191, email 

mara.j.brown@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the special local 

regulations in 33 CFR 100.703 for the 

OPA World Championships identified in 

Table 1 to § 100.703, Item No. 8, from 

8 a.m. until 6 p.m., on November 18, 

2023, through November 19, 2023. This 

action is being taken to provide for the 

safety of life on navigable waterways 

during this event. Our regulation for 

recurring marine events, Sector St. 

Petersburg, § 100.703, Table 1 to 

§ 100.703, Item No. 8, specifies the 

locations of the regulated area for the 

OPA World Championships which 

encompasses portions of the Gulf of 

Mexico near Englewood, FL. During the 

enforcement periods, as reflected in 

§ 100.703(c), if you are the operator of 

a vessel in the regulated area you must 

comply with directions from the Patrol 

Commander or any designated 

representative. 

In addition to this notice of 

enforcement in the Federal Register, the 

Coast Guard plans to provide 

notification of this enforcement period 

via the Local Notice to Mariners, marine 

information broadcasts, or both. 

Dated: November 2, 2023. 

Michael P. Kahle, 

Captain, U.S. Coast Guard, Captain of the 

Port St. Petersburg. 

[FR Doc. 2023–24787 Filed 11–8–23; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2023–0883] 

Safety Zone; Military Ocean Terminal 

Concord Safety Zone, Suisun Bay, 

Military Ocean Terminal Concord, CA 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

a safety zone in the navigable waters of 

Suisun Bay, off Concord, CA, in support 

of explosive on-loading to Military 

Ocean Terminal Concord (MOTCO) on 

November 13, 2023, through November 

20, 2023. This safety zone is necessary 

to protect personnel, vessels, and the 

marine environment from potential 

explosion within the explosive arc. The 

safety zone is open to all persons and 

vessels for transitory use, but vessel 

operators desiring to anchor or 

otherwise loiter within the safety zone 

must obtain the permission of the 

Captain of the Port San Francisco or a 

designated representative. All persons 

and vessels operating within the safety 

zone must comply with all directions 

given to them by the Captain of the Port 

San Francisco or a designated 

representative. 

DATES: The regulations in 33 CFR 

165.1198 will be enforced from 12:01 

a.m. on November 13, 2023, until 11:59 

p.m. on November 20, 2023. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

notification of enforcement, call, or 

email LT Abby Hamann, U.S. Coast 

Guard Sector San Francisco, Waterways 

Management Division, at 415–399–3585, 

SFWaterways@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the safety zone in 33 

CFR 165.1198 for the Military Ocean 

Terminal Concord, CA (MOTCO) 

regulated area from 12:01 a.m. on 

November 13, 2023, until 11:59 p.m. on 


ddrumheller on DSK120RN23PROD with RULES1