Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 26989 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: On February 14, 2022, the 

Department of Labor (Department) 

concurrently published both a direct 

final rule (DFR) and proposed rule 

putting forth guidance on priority 

service, durational limits, and State Plan 

submissions regarding a State’s Senior 

Community Service Employment 

Program, or SCSEP. Because the 

Department did not receive any 

significant adverse comments within the 

scope of the rulemaking, the Department 

is implementing the DFR as published. 

DATES: As of May 6, 2022, the 

Department is confirming the effective 

date of the rule published February 14, 

2022 at 87 FR 8186 as April 15, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Steven Rietzke, Chief, Division of 

National Programs, Tools and Technical 

Assistance, Office of Workforce 

Investment, at 202–693–3980 (this is not 

a toll-free number). 

SUPPLEMENTARY INFORMATION: The DFR 

published at 87 FR 8186 on February 14, 

2022, became effective on April 15, 

2022. In the DFR, the Department stated 

that the DFR would become effective 

April 15, 2022 without further action, 

unless significant adverse comments 

were submitted by March 16, 2022 (the 

end of the public comment period), and 

the Department would publish a timely 

withdrawal of the proposed rule. In the 

same issue of the Federal Register in 

which this notice is published, the 

Department is publishing a withdrawal 

of the proposed rule, which was also 

published on February 14, 2022. 

The Department received seven 

comments on this rulemaking. Several 

of these comments were supportive of 

the provisions this rulemaking proposed 

to implement. While other comments 

could be characterized as negative or 

adverse, none of those comments were 

significant or within the scope of this 

rulemaking. One commenter was 

opposed to the time limit; however, that 

time limit is set forth in the Supporting 

Older Americans Act of 2020, and is, 

therefore, a statutory requirement 

beyond the purview of the rulemaking. 

The remaining comments were outside 

the scope of the rulemaking. The 

comments are publicly available as part 

of the rulemaking docket at https://

www.regulations.gov/docket/ETA-2022- 

0002/comments. 

The Department has determined that 

none of the adverse comments are 

significant and within the scope of the 

rulemaking. Therefore, the DFR 

published at 87 FR 8186 on February 14, 

2022, became effective on April 15, 

2022. 

Angela Hanks, 

Acting Assistant Secretary for Employment 

and Training, Labor. 

[FR Doc. 2022–09491 Filed 5–5–22; 8:45 am] 

BILLING CODE 4510–FN–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2022–N–0289] 

Medical Devices; Cardiovascular 

Devices; Classification of the Reverse 

Central Venous Recanalization System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the reverse central venous 

recanalization 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 reverse 

central venous recanalization 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. 

DATES: This order is effective May 6, 

2022. The classification was applicable 

on February 10, 2020. 

FOR FURTHER INFORMATION CONTACT: Finn 

Donaldson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2568, Silver Spring, 

MD 20993–0002, 301–796–9579, 

Finn.Donaldson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

reverse central venous recanalization 

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 

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) of the FD&C Act. 

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 


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26990 Federal Register / Vol. 87, No. 88 / Friday, May 6, 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. 

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 (PMA) 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 

For this device, FDA issued an order 

on March 21, 2016, finding the Surfacer 

Inside-Out Access Catheter System not 

substantially equivalent to a predicate 

not subject to PMA. Thus, the device 

remained in class III in accordance with 

section 513(f)(1) of the FD&C Act when 

we issued the order. 

On August 15, 2019, FDA received 

Bluegrass Vascular Technologies, Inc.’s 

request for De Novo classification of the 

Surfacer Inside-Out Access Catheter 

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. 

Therefore, on February 10, 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 870.1342.1 We have named the 

generic type of device reverse central 

venous recanalization system, and it is 

identified as a prescription device for 

obtaining central venous access to 

facilitate catheter insertion into the 

central venous system. Reverse 

recanalization involves the initiation of 

an access path from within the vein and 

then progressing to the skin for patients 

with upper body venous occlusions or 

other conditions that preclude central 

venous access by other methods. 

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—REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

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

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

Embolization caused by component fracture ........................................... Clinical performance testing, and Non-clinical performance testing. 

Death, bleeding, damage to non-target tissue and organs, blood vessel 

perforation or rupture, hematoma; or delays to therapy from failure to 

achieve central venous access.

Clinical performance testing, Non-clinical performance 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. This device is 

subject to premarket notification 

requirements under section 510(k) of the 

FD&C Act. 

At the time of classification, reverse 

central venous recanalization 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 (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 870 

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 870 is 

amended as follows: 


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Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 26991 

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 § 870.1342 to subpart B to read 

as follows: 

§ 870.1342 Reverse central venous 

recanalization system. 

(a) Identification. A reverse central 

venous recanalization system is a 

prescription device for obtaining central 

venous access to facilitate catheter 

insertion into the central venous system. 

Reverse recanalization involves the 

initiation of an access path from within 

the vein and then progressing to the 

skin for patients with upper body 

venous occlusions or other conditions 

that preclude central venous access by 

other methods. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

fulfill the following: 

(i) Demonstrate the ability to safely 

deliver, deploy, and remove the device; 

and 

(ii) Evaluate all adverse events 

including death, bleeding, damage to 

non-target tissue and organs, blood 

vessel perforation or rupture, and 

hematoma. 

(2) 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) Simulated-use testing in a 

clinically relevant bench anatomic 

model to assess the delivery, 

deployment, and retrieval of the system; 

(ii) Compatibility with other devices 

labeled for use with the device; 

(iii) Tensile strengths of joints and 

components; 

(iv) Kink resistance of system 

components; 

(v) Radiopacity of components used to 

monitor procedure under fluoroscopy; 

(vi) Characterization and verification 

of all dimensions; and 

(vii) Leakage of air or fluid. 

(3) All 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 the 

shelf life of the device by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

identified shelf life. 

(6) Labeling for the device must 

include: 

(i) Instructions for use, including a 

description of compatible devices; 

(ii) A detailed summary of the clinical 

testing conducted and; 

(iii) Shelf life and storage conditions. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09745 Filed 5–5–22; 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–2022–N–0141] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Magnetically Maneuvered Capsule 

Endoscopy System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the magnetically 

maneuvered capsule endoscopy 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 

magnetically maneuvered capsule 

endoscopy 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. 

DATES: This order is effective May 6, 

2022. The classification was applicable 

on May 22, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Cole, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2536, Silver Spring, 

MD 20993–0002, 301–796–8587, 

Stephanie.Cole@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

magnetically maneuvered capsule 

endoscopy 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 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) of the FD&C Act. 

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 


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