Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Rules and Regulations 75949 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2024–0470; Project 

Identifier AD–2023–00694–A; Amendment 

39–22800; AD 2024–15–09] 

RIN 2120–AA64 

Airworthiness Directives; Textron 

Aviation Inc. (Type Certificate 

Previously Held by Cessna Aircraft 

Company) Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: The FAA is adopting a new 

airworthiness directive (AD) for Textron 

Aviation Inc. (Textron) (type certificate 

previously held by Cessna Aircraft 

Company) Model 525, 525A, and 525B 

airplanes with Tamarack active 

technology load alleviation system 

(ATLAS) winglets installed per 

Supplemental Type Certificate (STC) 

No. SA03842NY. This AD was 

prompted by a report of the potential for 

a failure of the ATLAS system in which 

a loss of load alleviation would be unannunciated. This AD requires 

installing placards on the left-hand 

inboard edge of the Tamarack active 

camber surface (TACS) and revising the 

existing airplane flight manual (AFM) 

for your airplane. The FAA is issuing 

this AD to address the unsafe condition 

on these products. 

DATES: This AD is effective October 22, 

2024. 

The Director of the Federal Register 

approved the incorporation by reference 

of certain publications listed in this AD 

as of October 22, 2024. 

ADDRESSES: 

AD Docket: You may examine the AD 

docket at regulations.gov under Docket 

No. FAA–2024–0470; or in person at 

Docket Operations between 9 a.m. and 

5 p.m., Monday through Friday, except 

Federal holidays. The AD docket 

contains this final rule, any comments 

received, and other information. The 

address for Docket Operations is U.S. 

Department of Transportation, Docket 

Operations, M–30, West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Avenue SE, Washington, DC 

20590. 

Material Incorporated by Reference: 

• 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. 

• You may view this material at the 

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. It is also 

available at regulations.gov under 

Docket No. FAA–2024–0470. 

FOR FURTHER INFORMATION CONTACT: 

Anthony Caldejon, Aviation Safety 

Engineer, FAA, 3960 Paramount 

Boulevard, Lakewood, CA 90712; 

phone: (206) 231–3534; email: 

anthony.v.caldejon@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The FAA issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 by adding an AD that would 

apply to Textron (type certificate 

previously held by Cessna Aircraft 

Company) Model 525, 525A, and 525B 

airplanes with Tamarack ATLAS 

winglets installed per STC No. 

SA03842NY. The NPRM published in 

the Federal Register on March 22, 2024 

(89 FR 20354). The NPRM was 

prompted by a report that while 

accomplishing a reliability 

improvement program, Tamarack 

discovered the potential for a failure of 

the ATLAS system in which a loss of 

load alleviation would be unannunciated. The manufacturer’s 

investigation revealed that failure of 

either of one of a pair of opto-isolators 

within the ATLAS Control Unit (ACU) 

can prevent an enable signal from being 

sent to the TACS Control Units (TCUs). 

The ATLAS system is installed on 

Textron Model 525, 525A, and 525B 

airplanes under STC No. SA03842NY 

and lessens the increased wing loads 

associated with the installation of 

winglets. The ATLAS is designed to 

detect flight conditions and modify 

airflow at the wing tip accordingly. The 

ATLAS will draw power constantly to 

operate the logic circuit and provide 

power to the actuators to maintain 

TACS position. 

The TCUs include the linear electric 

actuators and motor controllers that 

move the TACS. Since the enable 

signals are not monitored after the optoisolators, the ACU cannot detect 

whether the generated signal is reaching 

the TCUs. The TCUs rely on the enable 

signal to determine whether to respond 

to commands from the ACU. If one of 

the opto-isolators fails, the ACU would 

not be able to detect that the TCUs were 

not enabled and the TCUs would not 

respond to commands from the ACU. 

Thus, the system would be operating in 

a mode of un-annunciated loss of load 

alleviation. The flight crew would be 

unaware of a malfunction of the load 

alleviation function of ATLAS and 

could fly the airplane into conditions 

that exceed the limit load. In addition, 

fatigue concerns could result in cracking 

of the airplane’s primary structure. If 

not addressed, this condition could 

result in loss of continued safe flight 

and landing of the airplane. 

In the NPRM, the FAA proposed to 

require installing placards on the lefthand inboard edge of the TACS to 

enhance visibility of TACS movement 

during night operations and revising the 

existing AFM for your airplane to 

include instructions for pre-flight 

checks of the ATLAS system before taxi. 

The FAA is issuing this AD to address 

the unsafe condition on these products. 

Discussion of Final Airworthiness 

Directive 

Comments 

The FAA received comments from 

three commenters. Two of the 

commenters were individuals who 

supported the NPRM. The third 

commenter was Tamarack. The 

following presents the comments 

received on the NPRM from Tamarack 

and the FAA’s response to each 

comment. 

Request To Clarify What Prompted the 

NPRM 

Tamarack requested that the FAA 

correct the SUMMARY and paragraph 

(e), ‘‘Unsafe Condition,’’ which state 

that the NPRM was prompted by a 

report of an un-annunciated failure of 

the ATLAS system. Tamarack 

commented that this statement is not 

accurate because even though Tamarack 

reported the design deficiency to the 

FAA under 14 CFR 21.3, ‘‘Reporting of 

failures, malfunctions, and defects,’’ 

there had not been any actual failures of 

the ATLAS system in the fleet. 

Tamarack stated that the ‘‘Background’’ 

section of the NPRM more accurately 

explains that, while accomplishing a 

reliability improvement program, 

Tamarack discovered the potential for a 

failure of the ATLAS system in which 

a loss of load alleviation would be unannunciated. 

The FAA agrees to correct the 

language identified by the commenter 

and has revised the SUMMARY and 

paragraph (e) of this AD accordingly. 

Request To Revise ‘‘Proposed AD 

Requirements in This NPRM’’ Section 

Tamarack requested that the FAA 

revise the ‘‘Proposed AD Requirements 

in This NPRM’’ section of the NPRM to 

specify who can accomplish the 

required actions. Tamarack stated that it 

is unclear whether a pilot can install the 


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placards on the left-hand inboard edge 

of the TACS or whether the placards 

must be installed by a certificated 

airframe and powerplant (A&P) 

mechanic. 

Paragraph (g) of this AD only allows 

a pilot to do the revision to the AFM 

required by paragraph (g)(2) of this AD 

and does not allow a pilot to do the 

installation of placards required by 

paragraph (g)(1) of this AD. An FAAcertificated A&P mechanic or repair 

station must install the placards on the 

left-hand inboard edge of the TACS. The 

FAA has not revised the ‘‘Proposed AD 

Requirements in This NPRM’’ section as 

requested by the commenter because 

that section of the NPRM is not carried 

over into this final rule. 

Request To Revise ‘‘FAA’s 

Determination’’ Section of the NPRM 

Tamarack requested that the FAA 

revise the ‘‘FAA’s Determination’’ 

section of the NPRM, which states that 

the FAA has determined that the unsafe 

condition is likely to exist or develop on 

other products of the same type design. 

Tamarack stated that the probability of 

the unsafe condition is ‘‘remote’’ and 

not ‘‘likely’’ and therefore using ‘‘likely’’ 

misrepresents the probability of the 

identified unsafe condition occurring in 

the fleet. 

The FAA disagrees. The ‘‘FAA’s 

Determination’’ section of the NPRM 

correlates to the FAA’s finding under 14 

CFR 39.5, which states the conditions 

that must be present when the FAA 

issues an AD. If an unsafe condition 

only exists on one product and is not 

likely to exist or develop on other 

products of the same type design, or if 

there are no other existing products of 

the same type design, the FAA will 

accomplish corrective action through 

means other than an AD. The FAA’s 

finding under 14 CFR 39.5 is unrelated 

to the probability of the failure 

condition described by the commenter. 

The FAA did not revise this final rule 

regarding this issue. 

Conclusion 

The FAA reviewed the relevant data, 

considered any comments received, and 

determined that air safety requires 

adopting this AD as proposed. 

Accordingly, the FAA is issuing this AD 

to address the unsafe condition on these 

products. Except for the change 

described previously, this AD is 

adopted as proposed in the NPRM. 

Material Incorporated by Reference 

Under 1 CFR Part 51 

The FAA reviewed Tamarack 

Aerospace Atlas Service Bulletin 

SBATLAS–57–06, Issue A, dated April 

19, 2023. This material specifies 

procedures for installing placards on the 

left-hand inboard edge of the TACS to 

enhance visibility of TACS movement 

during night operations. 

The FAA also reviewed the following 

AFM supplements, which contain, 

among other items, instructions for preflight checks of the ATLAS system 

before taxi. These documents are 

distinct because they apply to different 

airplane models. 

• Tamarack Aerospace Cessna 

Citation Model 525, 525–0001 thru 

–0359, AFM Supplement TAG–1101– 

0099 CA/DD/M023, Tamarack Active 

Technology Load Alleviation System 

(Atlas) Winglets, Issue D, dated 

September 20, 2023. 

• Tamarack Aerospace Cessna 

Citation Model 525, 525–0360 through 

–0599, AFM Supplement TAG–1101– 

1099 CA/DD/M037, Tamarack Active 

Technology Load Alleviation System 

(Atlas) Winglets, Issue D, dated 

September 20, 2023. 

• Tamarack Aerospace Cessna 

Citation Model 525, 525–0600 through 

–0684 and –0686 through –0701, AFM 

Supplement TAG–1101–P099 CA/DD/ 

M038, Tamarack Active Technology 

Load Alleviation System (Atlas) 

Winglets, Issue D, dated September 20, 

2023. 

• Tamarack Aerospace Cessna 

Citation Model 525, 525–0685 and 

–0800 and on, AFM Supplement TAG– 

1101–M099 CA/DD/M088, Tamarack 

Active Technology Load Alleviation 

System (Atlas) Winglets, Issue D, 

September 20, 2023. 

• Tamarack Aerospace Cessna 

Citation Model 525A, 525A–0001 thru 

–0299, AFM Supplement TAG–1102– 

0099 CAS/AFM0003, Tamarack Active 

Technology Load Alleviation System 

(Atlas) Winglets, Issue C, September 20, 

2023. 

• Tamarack Aerospace Cessna 

Citation Model 525A, 525A–0300 and 

on, AFM Supplement TAG–1102–P099 

CAS/AFM0004, Tamarack Active 

Technology Load Alleviation System 

(Atlas) Winglets, Issue C, September 20, 

2023. 

• Tamarack Aerospace Cessna 

Citation Jet Model 525B, 525B–0001 

thru 525B–0056 and 525B–0058 thru 

525B–0450, AFM Supplement TAG– 

1103–0099 CAS/AFM0001, Tamarack 

Active Technology Load Alleviation 

System (Atlas) Winglets, Issue C, 

September 20, 2023. 

• Tamarack Aerospace Cessna 

Citation Jet 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. 

This material is reasonably available 

because the interested parties have 

access to it through their normal course 

of business or by the means identified 

in the ADDRESSES section. 

Costs of Compliance 

The FAA estimates that this AD 

affects 148 airplanes of U.S. registry. 

The FAA estimates the following 

costs to comply with this AD: 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per 

product 

Cost on U.S. 

operators 

Install placards ................................................ 0.5 work-hour × $85 per hour = $42.50 ......... $20 $62.50 $9,250 

Revise AFM .................................................... 1 work-hour × $85 per hour = $85 ................. 0 85 12,580 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. Subtitle VII: 

Aviation Programs, describes in more 

detail the scope of the Agency’s 

authority. 

The FAA is issuing this rulemaking 

under the authority described in 

Subtitle VII, Part A, Subpart III, Section 

44701: General requirements. Under 

that section, Congress charges the FAA 

with promoting safe flight of civil 

aircraft in air commerce by prescribing 

regulations for practices, methods, and 

procedures the Administrator finds 

necessary for safety in air commerce. 

This regulation is within the scope of 

that authority because it addresses an 

unsafe condition that is likely to exist or 


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develop on products identified in this 

rulemaking action. 

Regulatory Findings 

This AD will not have federalism 

implications under Executive Order 

13132. This AD will not have a 

substantial direct effect on the States, on 

the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify that this AD: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Will not affect intrastate aviation 

in Alaska, and 

(3) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive: 

2024–15–09 Textron Aviation Inc. (Type 

Certificate Previously Held by Cessna 

Aircraft Company): Amendment 39– 

22800; Docket No. FAA–2024–0470; 

Project Identifier AD–2023–00694–A. 

(a) Effective Date 

This airworthiness directive (AD) is 

effective October 22, 2024. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Textron Aviation Inc. 

(type certificate previously held by Cessna 

Aircraft Company) Model 525, 525A, and 

525B airplanes, all serial numbers (S/Ns), 

certificated in any category, with Tamarack 

active technology load alleviation system 

(ATLAS) winglets installed in accordance 

with Supplemental Type Certificate No. 

SA03842NY. 

(d) Subject 

Joint Aircraft System Component (JASC) 

Code 2770, Gust Lock/Damper System 

(e) Unsafe Condition 

This AD was prompted by a report of the 

potential for a failure of the ATLAS system 

in which a loss of load alleviation would be 

un-annunciated. The FAA is issuing this AD 

to address un-annunciated loss of load 

alleviation which, if not addressed, could 

lead to the flight crew flying the airplane into 

conditions that exceed the limit load, as well 

as fatigue cracking in the airplane’s primary 

structure. This could result in loss of 

continued safe flight and landing of the 

airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Actions 

Within 60 hours time-in-service or 6 

months after the effective date of this AD, 

whichever occurs first, do the actions 

required by paragraphs (g)(1) and (2) of this 

AD. 

(1) Install placards on the left-hand 

Tamarack active camber surface (TACS) in 

accordance with steps 1 through 3 of the 

Accomplishment Instructions in Tamarack 

Aerospace Atlas Service Bulletin SBATLAS– 

57–06, Issue A, dated April 19, 2023. 

(2) Revise the Normal Procedures section 

of the existing airplane flight manual (AFM) 

for your airplane by adding the information 

in Figure 1 to paragraph (g)(2) of this AD 

under ‘‘Before Taxi’’ or by incorporating the 

AFM supplement applicable to your airplane 

identified in Figure 2 to paragraph (g)(2) of 

this AD. Using a different document with 

information identical to this information 

under ‘‘Before Taxi’’ in the AFM for your 

airplane is acceptable for compliance with 

the requirements of this paragraph. The 

owner/operator (pilot) holding at least a 

private pilot certificate may revise the 

existing AFM for your airplane and must 

enter compliance with the applicable 

paragraph of this AD into the airplane 

maintenance records in accordance with 14 

CFR 43.9(a) and 91.417(a)(2)(v). The record 

must be maintained as required by 14 CFR 

91.417, 121.380, or 135.439. 

FIGURE 1 TO PARAGRAPH (g)(2)—ATLAS CHECK PROCEDURE

Before Taxi 

WARNING 

The TACS should move rapidly and forcefully trailing edge up and return to the neutral position when the ATLAS first receives 

power. Be sure that all personnel and equipment are clear before moving switch to the ON position. 

ATLAS System ................................................................................................................................................................ CHECK 

(Test that the ATLAS is working properly.) 

a. In poor light or dark conditions, turn on left side reading light. 

b. In poor light or dark conditions, turn on Wing Inspection Light. 

c. ATLAS INOP Button—Press 3 times within 3 seconds. ATLAS INOP Button light will flash 3 times when system goes through BIT 

(Built In Test). 

WARNING 

The TACS should move rapidly and forcefully trailing edge up and return to the neutral position when running the BIT function. Be sure that all personnel and equipment are clear before pressing. 

d. TACS ........................................................................................................................................................................... CHECK MOVEMENT 

Both TACS should rapidly move up and return to the neutral position. 

i. If the TACS do not move after completing step c., this may indicate that ATLAS is not functioning normally. 

ii. Refer to Abnormal Procedure ATLAS INOPERATIVE ON THE GROUND (TACS DO NOT MOVE IN BIT). 

e. Wait approximately 10 seconds. 

f. ATLAS INOP Button light ............................................................................................................................................. CHECK OFF 

g. If left side reading light is illuminated, turn off at pilot’s discretion. 

h. If Wing Inspection Light is illuminated, turn off at pilot’s discretion. 

NOTE 

If annunciator remains illuminated, or if the TACS do not move, a fault has been identified in the system. In either case refer to Abnormal Procedures ATLAS INOPERATIVE ON THE GROUND. 


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FIGURE 2 TO PARAGRAPH (g)(2)—TAMARACK ATLAS AFM SUPPLEMENTS

Model and S/N Tamarack ATLAS AFM supplement 

Model 525, S/Ns 525–0001 through 525–0359 inclusive ........................ Paragraph 3A, ATLAS System, under ‘‘Before Taxiing’’ in the Normal 

Procedures section of Cessna Citation Model 525, 525–0001 thru 

–0359, AFM Supplement TAG–1101–0099 CA/DD/M023, Tamarack 

Active Technology Load Alleviation System (Atlas) Winglets, Issue D, 

dated September 20, 2023. 

Model 525, S/Ns 525–0360 through 525–0599 inclusive ........................ Paragraph 3A, ATLAS System, under ‘‘Before Taxi’’ in the Normal Procedures section of Cessna Citation Model 525, 525–0360 thru 

–0599, AFM Supplement TAG–1101–1099 CA/DD/M037, Tamarack 

Active Technology Load Alleviation System (Atlas) Winglets, Issue D, 

dated September 20, 2023. 

Model 525, S/Ns 525–0600 through 525–0684 inclusive and S/Ns 525– 

0686 through 525–0701 inclusive.

Paragraph 1A, ATLAS System, under ‘‘Before Taxi’’ in the Normal Procedures section of Cessna Citation Model 525, 525–0600 through 

–0684 and –0686 through –0701, AFM Supplement TAG–1101– 

P099 CA/DD/M038, Tamarack Active Technology Load Alleviation 

System (Atlas) Winglets, Issue D, dated September 20, 2023. 

Model 525, S/N 525–0685 and S/Ns 525–0800 and larger .................... Paragraph 9A, ATLAS System, under ‘‘Before Taxi’’ in the Normal Procedures section of Cessna Citation Model 525, 525–0685 and –0800 

and on, AFM Supplement TAG–1101–M099 CA/DD/M088, Tamarack 

Active Technology Load Alleviation System (Atlas) Winglets, Issue D, 

dated September 20, 2023. 

Model 525A, S/Ns 525A–0001 through 525–0299 inclusive ................... Paragraph 3A, ATLAS System, under ‘‘Before Taxi’’ in the Normal Procedures section of Cessna Citation Model 525A, 525A–0001 thru 

–0299, AFM Supplement TAG–1102–0099 CAS/AFM0003, Tamarack Active Technology Load Alleviation System (Atlas) Winglets, 

Issue C, dated September 20, 2023. 

Model 525A, S/Ns 525A–0300 and larger ............................................... Paragraph 1A, ATLAS System, under ‘‘Before Taxi’’ in the Normal Procedures section of Cessna Citation Model 525A, 525A–0300 and on, 

AFM Supplement TAG–1102–P099 CAS/AFM0004, Tamarack Active 

Technology Load Alleviation System (Atlas) Winglets, Issue C, dated 

September 20, 2023. 

Model 525B, S/Ns 525B–0001 through 525B–0056 inclusive and S/Ns 

525B–0058 through 525B–0450 inclusive.

Paragraph 1A, ATLAS System, under ‘‘Before Taxi’’ in the Normal Procedures section of Cessna CitationJet Model 525B, 525B–0001 thru 

525B–0056 and 525B–0058 thru 525B–0450, AFM Supplement 

TAG–1103–0099 CAS/AFM0001, Tamarack Active Technology Load 

Alleviation System (Atlas) Winglets, Issue C, dated September 20, 

2023. 

Model 525B, S/N 525B–0057 and S/Ns 525B–0451 and larger ............. Paragraph 9A, ATLAS System, under ‘‘Before Taxi’’ in the Normal Procedures section of 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, dated September 20, 2023. 

(h) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, West Certification 

Branch, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. In 

accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the West Certification 

Branch, send it to the attention of the person 

identified in paragraph (i) of this AD and 

email it to 9-ANM-Seattle-ACO-AMOCRequests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local Flight Standards District Office/ 

certificate holding district office. 

(i) Related Information 

For more information about this AD, 

contact Anthony Caldejon, Aviation Safety 

Engineer, FAA, 3960 Paramount Boulevard, 

Lakewood, CA 90712; phone: (206) 231– 

3534; email: anthony.v.caldejon@faa.gov. 

(j) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

the material listed in this paragraph under 5 

U.S.C. 552(a) and 1 CFR part 51. 

(2) You must use this material as 

applicable to do the actions required by this 

AD, unless the AD specifies otherwise. 

(i) Tamarack Aerospace Atlas Service 

Bulletin SBATLAS–57–06, Issue A, dated 

April 19, 2023. 

(ii) Tamarack Aerospace Cessna Citation 

Model 525, 525–0001 thru –0359, Airplane 

Flight Manual (AFM) Supplement TAG– 

1101–0099 CA/DD/M023, Tamarack Active 

Technology Load Alleviation System (Atlas) 

Winglets, Issue D, dated September 20, 2023. 

(iii) Tamarack Aerospace Cessna Citation 

Model 525, 525–0360 thru –0599, AFM 

Supplement TAG–1101–1099 CA/DD/M037, 

Tamarack Active Technology Load 

Alleviation System (Atlas) Winglets, Issue D, 

dated September 20, 2023. 

(iv) Tamarack Aerospace Cessna Citation 

Model 525, 525–0600 through –0684 and 

–0686 through –0701, AFM Supplement 

TAG–1101–P099 CA/DD/M038, Tamarack 

Active Technology Load Alleviation System 

(Atlas) Winglets, Issue D, dated September 

20, 2023. 

(v) Tamarack Aerospace Cessna Citation 

Model 525, 525–0685 and –0800 and on, 

AFM Supplement TAG–1101–M099 CA/DD/ 

M088, Tamarack Active Technology Load 

Alleviation System (Atlas) Winglets, Issue D, 

September 20, 2023. 

(vi) Tamarack Aerospace Cessna Citation 

Model 525A, 525A–0001 thru –0299, AFM 

Supplement TAG–1102–0099 CAS/ 

AFM0003, Tamarack Active Technology 

Load Alleviation System (Atlas) Winglets, 

Issue C, September 20, 2023. 

(vii) Tamarack Aerospace Cessna Citation 

Model 525A, 525A–0300 and on, AFM 

Supplement TAG–1102–P099 CAS/ 

AFM0004, Tamarack Active Technology 

Load Alleviation System (Atlas) Winglets, 

Issue C, September 20, 2023. 

(viii) Tamarack Aerospace Cessna 

CitationJet Model 525B, 525B–0001 thru 

525B–0056 and 525B–0058 thru 525B–0450, 

AFM Supplement TAG–1103–0099 CAS/ 

AFM0001, Tamarack Active Technology 

Load Alleviation System (Atlas) Winglets, 

Issue C, September 20, 2023. 


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(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 


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