Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 75953 

(ix) Tamarack Aerospace Cessna CitationJet 

Model 525B, 525B–0057 and 525B–0451 and 

ON, AFM Supplement TAG–1103–P099 

CAS/AFM0002, Tamarack Active Technology 

Load Alleviation System (Atlas) Winglets, 

Issue D, September 20, 2023. 

(3) For Tamarack material identified in this 

AD, contact Tamarack Aerospace Group, Inc., 

2021 Industrial Drive, Sandpoint, ID 83864; 

phone: (208) 597–4568; website: 

tamarackaero.com/customer-support. 

(4) You may view this material at FAA, 

Airworthiness Products Section, Operational 

Safety Branch, 901 Locust, Kansas City, MO 

64106. For information on the availability of 

this material at the FAA, call (817) 222–5110. 

(5) You may view this material at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

visit www.archives.gov/federal-register/cfr/ 

ibr-locationsoremailfr.inspection@nara.gov. 

Issued on September 10, 2024. 

Steven W. Thompson, 

Acting Deputy Director, Compliance & 

Airworthiness Division, Aircraft Certification 

Service. 

[FR Doc. 2024–21112 Filed 9–16–24; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2024–N–4084] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Quantitative Viral Nucleic Acid Test 

for Transplant Patient Management 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the quantitative viral nucleic 

acid test for transplant patient 

management 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 quantitative 

viral nucleic acid test for transplant 

patient management’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 

17, 2024. The classification was 

applicable on July 30, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Silke Schlottmann, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3258, Silver Spring, 

MD 20993–0002, 301–796–9551, 

Silke.Schlottmann@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

quantitative viral nucleic acid test for 

transplant patient management 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 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 2, 2020, FDA received 

Roche Molecular Systems, Inc.’s request 

for De Novo classification of the cobas 

EBV. 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 July 30, 2020, FDA 

issued an order to the requester 

classifying the device into class II. In 


ddrumheller on DSK120RN23PROD with RULES1
75954 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / 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. 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 866.3183.1 We have named the 

generic type of device quantitative viral 

nucleic acid test for transplant patient 

management, and it is identified as a 

device intended for prescription use in 

the detection of viral pathogens by 

measurement of viral deoxyribonucleic 

acid (DNA) or ribonucleic acid (RNA) 

using specified specimen processing, 

amplification, and detection 

instrumentation. The test is intended for 

use as an aid in the management of 

transplant patients with active viral 

infection or at risk for developing viral 

infections. The test results are intended 

to be interpreted by qualified healthcare 

professionals in conjunction with other 

relevant clinical and laboratory 

findings. 

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—QUANTITATIVE VIRAL NUCLEIC ACID TEST FOR TRANSPLANT PATIENT MANAGEMENT RISKS AND MITIGATION

MEASURES

Identified risks to health Mitigation measures 

Risk of false results ............................................ Certain warnings, limitations, results interpretation information, and explanation of procedures 

in labeling; and 

Certain device descriptions and specifications, analytical studies, clinical studies, and risk analysis in design verification and validation. 

Failure to correctly interpret test results ............. Certain warnings, limitations, results interpretation information, and explanation of procedures 

in labeling. 

Failure to correctly operate the device ............... Certain warnings, limitations, results interpretation information, and explanation of procedures 

in 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. 

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 

parts 801 and 809, regarding labeling, 

have been approved under OMB control 

number 0910–0485. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, 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 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 866.3183 to subpart D to read 

as follows: 

§ 866.3183 Quantitative viral nucleic acid 

test for transplant patient management. 

(a) Identification. A quantitative viral 

nucleic acid test for transplant patient 

management is identified as a device 

intended for prescription use in the 

detection of viral pathogens by 

measurement of viral DNA or RNA 

using specified specimen processing, 

amplification, and detection 

instrumentation. The test is intended for 

use as an aid in the management of 

transplant patients with active viral 

infection or at risk for developing viral 

infections. The test results are intended 

to be interpreted by qualified healthcare 

professionals in conjunction with other 

relevant clinical and laboratory 

findings. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The labeling required under 

§ 809.10(b) of this chapter must include: 

(i) A prominent statement that the 

device is not intended for use as a donor 

screening test for the presence of viral 

nucleic acid in blood or blood products. 

(ii) Limitations which must be 

updated to reflect current clinical 

practice. These limitations must 

include, but are not limited to, 

statements that indicate: 

(A) Test results are to be interpreted 

by qualified licensed healthcare 

professionals in conjunction with 

clinical signs and symptoms and other 

relevant laboratory results; and 

(B) Negative test results do not 

preclude viral infection or tissue 

invasive viral disease and that test 

results must not be the sole basis for 

patient management decisions. 


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Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 75955 

(iii) A detailed explanation of the 

interpretation of results and acceptance 

criteria must be provided and include 

specific warnings regarding the 

potential for variability in viral load 

measurement when samples are 

measured by different devices. 

Warnings must include the following 

statement, where applicable: ‘‘Due to 

the potential for variability in [analyte] 

measurements across different [analyte] 

assays, it is recommended that the same 

device be used for the quantitation of 

[analyte] when managing individual 

patients.’’ 

(iv) A detailed explanation of the 

principles of operation and procedures 

for assay performance. 

(2) Design verification and validation 

must include the following: 

(i) Detailed documentation of the 

device description, including all parts 

that make up the device, ancillary 

reagents required for use with the assay 

but not provided, an explanation of the 

methodology, design of the primer/ 

probe sequences, rationale for the 

selected gene target, and specifications 

for amplicon size, guanine-cytosine 

content, and degree of nucleic acid 

sequence conservation. The design and 

nature of all primary, secondary and 

tertiary quantitation standards used for 

calibration must also be described. 

(ii) A detailed description of the 

impact of any software, including 

software applications and hardwarebased devices that incorporate software, 

on the device’s functions; 

(iii) Documentation and 

characterization (e.g., determination of 

the identity, supplier, purity, and 

stability) of all critical reagents and 

protocols for maintaining product 

integrity throughout its labeled shelflife. 

(iv) Stability data for reagents 

provided with the device and indicated 

specimen types, in addition to the basis 

for the stability acceptance criteria at all 

time points chosen across the spectrum 

of the device’s indicated life cycle, 

which must include a time point at the 

end of shelf life. 

(v) All stability protocols, including 

acceptance criteria. 

(vi) Final lot release criteria along 

with documentation of an appropriate 

justification that lots released at the 

extremes of the specifications will meet 

the claimed analytical and clinical 

performance characteristics as well as 

the stability claims. 

(vii) Risk analysis and documentation 

demonstrating how risk control 

measures are implemented to address 

device system hazards, such as Failure 

Mode Effects Analysis and/or Hazard 

Analysis. This documentation must 

include a detailed description of a 

protocol (including all procedures and 

methods) for the continuous monitoring, 

identification, and handling of genetic 

mutations and/or novel viral stains (e.g., 

regular review of published literature 

and annual in silico analysis of target 

sequences to detect possible primer or 

probe mismatches). All results of this 

protocol, including any findings, must 

be documented. 

(viii) Analytical performance testing 

that includes: 

(A) Detailed documentation of the 

following analytical performance 

studies: limit of detection, upper and 

lower limits of quantitation, inclusivity, 

precision, reproducibility, interference, 

cross reactivity, carry-over, quality 

control, specimen stability studies, and 

additional studies as applicable to 

specimen type and intended use for the 

device; 

(B) Identification of the viral strains 

selected for use in analytical studies, 

which must be representative of 

clinically relevant circulating strains; 

(C) Inclusivity study results obtained 

with a variety of viral genotypes as 

applicable to the specific assay target 

and supplemented by in silico analysis; 

(D) Reproducibility studies that 

include the testing of three independent 

production lots; 

(E) Documentation of calibration to a 

reference standard that FDA has 

determined is appropriate for the 

quantification of viral DNA or RNA 

(e.g., a recognized consensus standard); 

and 

(F) Documentation of traceability 

performed each time a new lot of the 

standardized reference material to 

which the device is traceable is 

released, or when the field transitions to 

a new standardized reference material. 

(ix) Clinical performance testing that 

includes: 

(A) Detailed documentation from 

either a method comparison study with 

a comparator that FDA has determined 

is appropriate, or results from a 

prospective clinical study 

demonstrating clinical validity of the 

device; 

(B) Data from patient samples, with an 

acceptable number of the virus-positive 

samples containing an analyte 

concentration near the lower limit of 

quantitation and any clinically relevant 

decision points. If an acceptable number 

of virus-positive samples containing an 

analyte concentration near the lower 

limit of quantitation and any clinically 

relevant decision cannot be obtained, 

contrived samples may be used to 

supplement sample numbers when 

appropriate, as determined by FDA; 

(C) The method comparison study 

must include predefined maximum 

acceptable differences between the test 

and comparator method across all 

primary outcome measures in the 

clinical study protocol; and 

(D) The final release test results for 

each lot used in the clinical study. 

Dated: September 12, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21086 Filed 9–16–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Parts 510, 525, 526, 536, 542, 

544, 546, 547, 548, 549, 550, 551, 552, 

553, 555, 558, 560, 562, 569, 570, 576, 

578, 579, 582, 583, 584, 585, 587, 588, 

589, 590, 591, 594, 598, and 599 

Updating Provisions Related to 

Blocking and Other Actions Related to 

Specific Property or Interests in 

Property 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Final rule. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is adopting a final rule 

to clarify OFAC’s process for issuing 

certain orders that block or identify as 

blocked specific property or interests in 

property, or that impose other 

prohibitions less than full blocking with 

respect to specific property or interests 

in property. OFAC is adding 

information about these orders in 

regulatory notes in 35 of OFAC’s 

sanctions regulations. 

DATES: This rule is effective September 

17, 2024. 

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 or https://ofac.treasury.gov/ 

contact-ofac. 

SUPPLEMENTARY INFORMATION: 

Electronic Availability 

This document and additional 

information concerning OFAC are 

available on OFAC’s website: https://

ofac.treasury.gov. 

Background 

In this rule, OFAC is updating 35 

parts of 31 CFR chapter V to clarify 

OFAC’s processes when it issues certain 


ddrumheller on DSK120RN23PROD with RULES1