72984 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 

§ 862.1676 Blood collection device for cellfree nucleic acids. 

(a) Identification. A blood collection 

device for cell-free nucleic acids is a 

device intended for medical purposes to 

collect, store, transport, and handle 

blood specimens and to stabilize and 

isolate cell-free nucleic acid 

components prior to further testing. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Design verification and validation 

documentation must include 

appropriate design inputs and design 

outputs that are essential for the proper 

functioning of the device for its 

intended use, including all of its 

indications for use, and must include 

the following: 

(i) Documentation demonstrating that 

appropriate, as determined by FDA, 

measures are in place (e.g., validated 

device design features and 

specifications) to ensure that users of 

blood collection device for cell-free 

nucleic acids devices are not exposed to 

undue risk of bloodborne pathogen 

exposure and operator injury during use 

of the device, including blood 

collection, transportation, and 

centrifugation processes. 

(ii) Documentation demonstrating that 

appropriate, as determined by FDA, 

measures are in place (e.g., validated 

device design features and 

specifications) to ensure that the device 

reproducibly and reliably collects, 

transports, stabilizes, and isolates cellfree nucleic acids of sufficient yield and 

quality suitable for downstream 

applications as appropriate for its 

intended use. At a minimum, these 

measures must include: 

(A) Data demonstrating that blood 

samples collected in the device have 

reproducible cell-free nucleic acid 

yields that are suitable, as determined 

by FDA, for downstream testing as 

appropriate for the intended use, 

including estimates of within-lot, 

within-device, and lot-to-lot variability; 

(B) Data demonstrating that cell-free 

nucleic acid yields isolated from blood 

specimens collected into the device do 

not add clinically significant bias to test 

results obtained using the downstream 

application(s) described in the intended 

use. For devices indicated for use with 

multiple downstream applications, data 

demonstrating acceptable performance 

for each type of claimed use or, 

alternatively, an appropriate, as 

determined by FDA, clinical 

justification for why such data are not 

needed; 

(C) Data demonstrating that the device 

appropriately stabilizes cell-free nucleic 

acids after sample collection, during 

storage, and during transport over the 

claimed shelf life of the device; 

(D) Data demonstrating that samples 

collected in the device have minimal 

levels of contamination with other types 

of nucleic acids present in cells or 

cellular components, and that these 

levels of contamination do not interfere 

with downstream testing; 

(E) Data from analytical or clinical 

studies that demonstrate that, when 

used as intended, the device 

consistently draws a blood sample 

volume that is within the indicated fill 

range; 

(F) Data from analytical or clinical 

studies that demonstrate that, when 

used as intended, cell-free nucleic acid 

yield, stability, and quality are not 

significantly impacted by interference 

due to other parts of the device (such as 

reduced or excess active ingredient) or 

specimen collection and processing 

procedures (such as hemolysis, 

centrifugation, or mixing of blood with 

anticoagulant or additives); and 

(G) Data from analytical studies that 

demonstrate that the device is suitable 

for its intended use across all storage 

and sample handling conditions 

described in the device labeling, 

including device shelf life and shipping 

conditions (e.g., temperature, humidity, 

duration). 

(iii) A protocol, reviewed and 

determined acceptable by FDA, that 

specifies the verification and validation 

activities that will be performed for 

anticipated device modifications to 

reevaluate performance claims or 

performance specifications. This 

protocol must include a process for 

assessing whether a modification to 

technology, engineering, performance, 

materials, specifications, or indications 

for use, or any combination thereof, 

could significantly affect the safety or 

effectiveness of the device. The protocol 

must include assessment metrics, 

acceptance criteria, and analytical 

methods for the performance testing of 

changes. 

Dated: September 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20254 Filed 9–6–24; 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–2024–N–4059] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Endoscopic Pancreatic Debridement 

Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the endoscopic pancreatic 

debridement device 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 

pancreatic debridement device’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 September 

9, 2024. The classification was 

applicable on December 23, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Thelma Valdes, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2610, Silver Spring, 

MD 20993–0002, 301–796–9621, 

Thelma.Valdes@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

endoscopic pancreatic debridement 

device 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 


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Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 72985 

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. 

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 part 860, subpart D 

(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 March 16, 2020, FDA received 

Interscope, Inc’s request for De Novo 

classification of the EndoRotor. 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 December 23, 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 876.4330.1 We have named the 

generic type of device endoscopic 

pancreatic debridement device, and it is 

identified as a device intended to be 

inserted via an endoscope and placed 

through a cystogastrostomy fistula into 

the pancreatic cavity. It is intended for 

removal of necrotic tissue from a walled 

off pancreatic necrosis (WOPN) cavity. 

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 PANCREATIC DEBRIDEMENT DEVICE RISKS AND MITIGATION MEASURES

Identified risks to health Mitigation measures 

Adverse tissue reaction ...................................................... Biocompatibility evaluation, and Pyrogenicity testing. 

Infection .............................................................................. Sterilization validation, Pyrogenicity testing, Shelf life testing, Package integrity testing, and Labeling. 

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

Injury due to device malfunction or device misuse: 

• Injury to pancreas or other non-target tissue. 

• Stent dislodgement. 

Clinical performance testing; Software validation, verification, and hazard analysis; 

Non-clinical performance testing; Labeling; and Training. 

Injury due to procedure or device: .....................................

• Hemorrhage/gastrointestinal (GI) bleeding. 

• Pneumoperitoneum. 

• Sepsis/multiorgan failure. 

• Morcellation of malignant tissue. 

Clinical performance testing, Labeling, and Training. 

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. 


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72986 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 

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 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 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—GASTROENTEROLOGYUROLOGY 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 § 876.4330 to subpart E to read 

as follows: 

§ 876.4330 Endoscopic pancreatic 

debridement device. 

(a) Identification. An endoscopic 

pancreatic debridement device is 

inserted via an endoscope and placed 

through a cystogastrostomy fistula into 

the pancreatic cavity. It is intended for 

removal of necrotic tissue from a walled 

off pancreatic necrosis (WOPN) cavity. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

demonstrate that the device performs as 

intended under anticipated conditions 

of use, including evaluation of 

debridement of walled off pancreatic 

necrosis and all adverse events. 

(2) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible. 

(3) Performance data must 

demonstrate the sterility of the patientcontacting components of the device. 

(4) The patient-contacting 

components of the device must be 

demonstrated to be non-pyrogenic. 

(5) Performance testing must support 

the shelf life of device components 

provided sterile by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

labeled shelf life. 

(6) 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) Testing of rotational speeds and 

vacuum pressure; 

(ii) Functional testing including 

testing with all device components and 

the ability to torque the device; and 

(iii) Functional testing in a relevant 

tissue model to demonstrate the ability 

to resect and remove tissue. 

(7) Performance data must 

demonstrate the electromagnetic 

compatibility (EMC) and electrical 

safety of the device. 

(8) Software verification, validation, 

and hazard analysis must be performed. 

(9) Training must be provided so that 

upon completion of the training 

program, the user can resect and remove 

tissue of interest while preserving nontarget tissue. 

(10) Labeling must include the 

following: 

(i) A summary of the clinical 

performance testing conducted with the 

device; 

(ii) Instructions for use, including the 

creation of a conduit for passage of 

endoscope and device into a walled off 

pancreatic necrotic cavity; 

(iii) Unless clinical performance data 

demonstrates that it can be removed or 

modified, a boxed warning stating that 

the device should not be used in 

patients with known or suspected 

pancreatic cancer; 

(iv) The recommended training for 

safe use of the device; and 

(v) A shelf life for any sterile 

components. 

Dated: September 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20248 Filed 9–6–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 591 

Publication of Venezuela Sanctions 

Regulations Web General License 5P 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Publication of web general 

license. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is publishing one 

general license (GL) issued pursuant to 

the Venezuela Sanctions Regulations: 

GL 5P, which was previously made 

available on OFAC’s website. 

DATES: GL 5P was issued on August 12, 

2024. See SUPPLEMENTARY INFORMATION

for additional relevant dates. 

FOR FURTHER INFORMATION CONTACT: 

OFAC: Assistant Director for Licensing, 

202–622–2480; Assistant Director for 

Regulatory Affairs, 202–622–4855; or 

Assistant Director for Compliance, 202– 

622–2490. 

SUPPLEMENTARY INFORMATION: 

Electronic Availability 

This document and additional 

information concerning OFAC are 

available on OFAC’s website: https://

ofac.treasury.gov. 

Background 

On August 12, 2024, OFAC issued GL 

5P to authorize certain transactions 

otherwise prohibited by the Venezuela 

Sanctions Regulations (VSR), 31 CFR 

part 591. GL 5P was made available on 

OFAC’s website (https://

ofac.treasury.gov) when it was issued. 

GL 5P supersedes GL 5O, which was 

issued on April 15, 2024. The text of GL 

5P is provided below. 

OFFICE OF FOREIGN ASSETS 

CONTROL 

Venezuela Sanctions Regulations 

31 CFR Part 591 

GENERAL LICENSE NO. 5P 

Authorizing Certain Transactions 

Related to the Petro ́leos de Venezuela, 

S.A. 2020 8.5 Percent Bond on or After 

November 12, 2024 

(a) Except as provided in paragraph 

(b) of this general license, on or after 


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