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173 

Federal Aviation Administration, DOT 

§ 21.616 

(b) The accountable manager speci-

fied in paragraph (a) of this section 
must be responsible within the appli-
cant’s or production approval holder’s 
organization for, and have authority 
over, all production operations con-
ducted under this part. The account-
able manager must confirm that the 
procedures described in the quality 
manual required by § 21.608 are in place 
and that the production approval hold-
er satisfies the requirements of the ap-
plicable regulations of subchapter C, 
Aircraft. The accountable manager 
must serve as the primary contact with 
the FAA. 

[Doc. No. FAA–2013–0933, Amdt. 21–98, 80 FR 
59032, Oct. 1, 2015] 

§ 21.607

Quality system. 

Each applicant for or holder of a TSO 

authorization must establish a quality 
system that meets the requirements of 
§ 21.137. 

§ 21.608

Quality manual. 

Each applicant for or holder of a TSO 

authorization must provide a manual 
describing its quality system to the 
FAA for approval. The manual must be 
in the English language and retrievable 
in a form acceptable to the FAA. 

§ 21.609

Location of or change to man-

ufacturing facilities. 

(a) An applicant may obtain a TSO 

authorization for manufacturing facili-
ties located outside of the United 
States if the FAA finds no undue bur-
den in administering the applicable re-
quirements of Title 49 U.S.C. and this 
subchapter. 

(b) The TSO authorization holder 

must obtain FAA approval before mak-
ing any changes to the location of any 
of its manufacturing facilities. 

(c) The TSO authorization holder 

must immediately notify the FAA, in 
writing, of any change to the manufac-
turing facilities that may affect the in-
spection, conformity, or airworthiness 
of its product or article. 

§ 21.610

Inspections and tests. 

Each applicant for or holder of a TSO 

authorization must allow the FAA to 
inspect its quality system, facilities, 
technical data, and any manufactured 
articles and witness any tests, includ-

ing any inspections or tests at a sup-
plier facility, necessary to determine 
compliance with this subchapter. 

§ 21.611

Issuance. 

If the FAA finds that the applicant 

complies with the requirements of this 
subchapter, the FAA issues a TSO au-
thorization to the applicant (including 
all TSO deviations granted to the ap-
plicant). 

§ 21.613

Duration. 

(a) A TSO authorization or letter of 

TSO design approval is effective until 
surrendered, withdrawn, or otherwise 
terminated by the FAA. 

(b) If a TSO is revised or canceled, 

the holder of an affected FAA letter of 
acceptance of a statement of conform-
ance, TSO authorization, or letter of 
TSO design approval may continue to 
manufacture articles that meet the 
original TSO without obtaining a new 
acceptance, authorization, or approval 
but must comply with the require-
ments of this chapter. 

§ 21.614

Transferability. 

The holder of a TSO authorization or 

letter of TSO design approval may not 
transfer the TSO authorization or let-
ter of TSO design approval. 

§ 21.616

Responsibility of holder. 

Each holder of a TSO authorization 

must— 

(a) Amend the document required by 

§ 21.605 as necessary to reflect changes 
in the organization and provide these 
amendments to the FAA. 

(b) Maintain a quality system in 

compliance with the data and proce-
dures approved for the TSO authoriza-
tion; 

(c) Ensure that each manufactured 

article conforms to its approved design, 
is in a condition for safe operation, and 
meets the applicable TSO; 

(d) Mark the TSO article for which 

an approval has been issued. Marking 
must be in accordance with part 45 of 
this chapter, including any critical 
parts; 

(e) Identify any portion of the TSO 

article (e.g., sub-assemblies, compo-
nent parts, or replacement articles) 
that leave the manufacturer’s facility 

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174 

14 CFR Ch. I (1–1–24 Edition) 

§ 21.618 

as FAA approved with the manufactur-
er’s part number and name, trademark, 
symbol, or other FAA approved manu-
facturer’s identification; 

(f) Have access to design data nec-

essary to determine conformity and 
airworthiness for each article produced 
under the TSO authorization. The man-
ufacturer must retain this data until it 
no longer manufactures the article. At 
that time, copies of the data must be 
sent to the FAA; 

(g) Retain its TSO authorization and 

make it available to the FAA upon re-
quest; and 

(h) Make available to the FAA infor-

mation regarding all delegation of au-
thority to suppliers. 

§ 21.618

Approval for deviation. 

(a) Each manufacturer who requests 

approval to deviate from any perform-
ance standard of a TSO must show that 
factors or design features providing an 
equivalent level of safety compensate 
for the standards from which a devi-
ation is requested. 

(b) The manufacturer must send re-

quests for approval to deviate, together 
with all pertinent data, to the FAA. If 
the article is manufactured under the 
authority of a foreign country or juris-
diction, the manufacturer must send 
requests for approval to deviate, to-
gether with all pertinent data, through 
the civil aviation authority of that 
country or jurisdiction to the FAA. 

[Docket No. FAA–2006–25877, Amdt. 21–92, 74 
FR 53392, Oct. 16, 2009, as amended by Doc. 
No. FAA–2018–0119, Amdt. 21–101, 83 FR 9169, 
Mar. 5, 2018] 

§ 21.619

Design changes. 

(a) 

Minor changes by the manufacturer 

holding a TSO authorization. The manu-
facturer of an article under an author-
ization issued under this part may 
make minor design changes (any 
change other than a major change) 
without further approval by the FAA. 
In this case, the changed article keeps 
the original model number (part num-
bers may be used to identify minor 
changes) and the manufacturer must 
forward to the FAA, any revised data 
that are necessary for compliance with 
§ 21.603(a). 

(b) 

Major changes by the manufacturer 

holding a TSO authorization. Any design 

change by the manufacturer extensive 
enough to require a substantially com-
plete investigation to determine com-
pliance with a TSO is a major change. 
Before making a major change, the 
manufacturer must assign a new type 
or model designation to the article and 
apply for an authorization under 
§ 21.603. 

(c) 

Changes by persons other than the 

manufacturer.  No design change by any 
person (other than the manufacturer 
who provided the statement of con-
formance for the article) is eligible for 
approval under this part unless the per-
son seeking the approval is a manufac-
turer and applies under § 21.603(a) for a 
separate TSO authorization. Persons 
other than a manufacturer may obtain 
approval for design changes under part 
43 or under the applicable airworthi-
ness regulations of this chapter. 

[Docket No. FAA–2006–25877, Amdt. 21–92, 74 
FR 53392, Oct. 16, 2009, as amended by Doc. 
No. FAA–2018–0119, Amdt. 21–101, 83 FR 9169, 
Mar. 5, 2018; Doc. No. FAA–2022–1355, Amdt. 
21–106, 87 FR 75710, Dec. 9, 2022] 

§ 21.620

Changes in quality system. 

After the issuance of a TSO author-

ization— 

(a) Each change to the quality sys-

tem is subject to review by the FAA; 
and 

(b) The holder of the TSO authoriza-

tion must immediately notify the FAA, 
in writing, of any change that may af-
fect the inspection, conformity, or air-
worthiness of its article. 

§ 21.621

Issue of letters of TSO design 

approval: Import articles. 

(a) The FAA may issue a letter of 

TSO design approval for an article— 

(1) Designed and manufactured in a 

foreign country or jurisdiction subject 
to the export provisions of an agree-
ment with the United States for the ac-
ceptance of these articles for import; 
and 

(2) For import into the United States 

if— 

(i) The State of Design certifies that 

the article has been examined, tested, 
and found to meet the applicable TSO 
or the applicable performance stand-
ards of the State of Design and any 
other performance standards the FAA 
may prescribe to provide a level of 

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