This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

52305 

Vol. 83, No. 201 

Wednesday, October 17, 2018 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2017–0127; Product 

Identifier 2016–NM–161–AD; Amendment 

39–19447; AD 2018–20–13] 

RIN 2120–AA64 

Airworthiness Directives; The Boeing 

Company Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for all The 

Boeing Company Model 737 airplanes, 

excluding Model 737–100, –200, –200C, 

–300, –400, and –500 series airplanes; 

all Model 757–200, –200PF, –200CB, 

and –300 series airplanes; and all Model 

767–200, –300, –300F, and –400ER 

series airplanes. This AD was prompted 

by reports of latently failed motoroperated valve (MOV) actuators of the 

fuel shutoff valves. This AD requires 

replacing certain MOV actuators of the 

fuel shutoff valves for the left and right 

engines (on certain airplanes) and of the 

auxiliary power unit (APU) fuel shutoff 

valve (on Model 757 and Model 767 

airplanes); and revising the maintenance 

or inspection program to incorporate 

certain airworthiness limitations 

(AWLs). We are issuing this AD to 

address the unsafe condition on these 

products. 

DATES: This AD is effective November 

15, 2018. 

The Director of the Federal Register 

approved the incorporation by reference 

of certain publications listed in this AD 

as of November 15, 2018. 

ADDRESSES: For service information 

identified in this final rule, contact 

Boeing Commercial Airplanes, 

Attention: Contractual & Data Services 

(C&DS), 2600 Westminster Blvd., MC 

110–SK57, Seal Beach, CA 90740–5600; 

telephone: 562–797–1717; internet: 

https://www.myboeingfleet.com. You 

may view this service information at the 

FAA, Transport Standards Branch, 2200 

South 216th St., Des Moines, WA. For 

information on the availability of this 

material at the FAA, call 206–231–3195. 

It is also available on the internet at 

http://www.regulations.gov by searching 

for and locating Docket No. FAA–2017– 

0127. 

Examining the AD Docket 

You may examine the AD docket on 

the internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2017– 

0127; 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, 

the regulatory evaluation, any 

comments received, and other 

information. The address for Docket 

Operations (phone: 800–647–5527) is 

Docket Operations, U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue SE, Washington, DC 20590. 

FOR FURTHER INFORMATION CONTACT: Tak 

Kobayashi, Aerospace Engineer, 

Propulsion Section, FAA, Seattle ACO 

Branch, 2200 South 216th St., Des 

Moines, WA 98198; phone and fax: 206– 

231–3553; email: Takahisa.Kobayashi@

faa.gov. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 by adding an AD that would 

apply to all The Boeing Company Model 

737–600, –700, –700C, –800, –900, and 

–900ER series airplanes; Model 757 

airplanes; and Model 767 airplanes. The 

NPRM published in the Federal 

Register on March 9, 2017 (82 FR 

13073). The NPRM was prompted by 

reports of latently failed MOV actuators 

of the fuel shutoff valves. The NPRM 

proposed to require replacing certain 

MOV actuators of the fuel shutoff valves 

for the left and right engines (on all 

airplanes) and of the APU fuel shutoff 

valve (on Model 757 and Model 767 

airplanes); and revising the maintenance 

or inspection program, as applicable, to 

incorporate certain AWLs. 

We subsequently issued a 

supplemental NPRM (SNPRM) to amend 

14 CFR part 39 by adding an AD that 

would apply to all Model 737 airplanes, 

excluding Model 737–100, –200, –200C, 

–300, –400, and –500 series airplanes; 

and all Model 757 and 767 airplanes. 

The SNPRM published in the Federal 

Register on April 3, 2018 (83 FR 14207). 

The SNPRM proposed to add Model 

737–8 airplanes and future Model 737 

airplanes to the applicability. 

We are issuing this AD to address a 

latent failure of the actuator for the 

engine or APU fuel shutoff valves, 

which could result in the inability to 

shut off fuel to the engine or the APU, 

and, in case of certain engine or APU 

fires, could result in structural failure. 

Republication 

Editorial Note: Rule document 2018–21460 

was originally published on pages 51304 

through 51313 in the issue of Thursday, 

October 11, 2018. In that publication, on page 

51307, in the second column, in (c)(1), 

‘‘Estimated –200’’ should read ‘‘–200’’. The 

corrected document is published here in its 

entirety. 

Comments 

We gave the public the opportunity to 

participate in developing this final rule. 

The following presents the comments 

received on the SNPRM and the FAA’s 

response to each comment. 

Request To Exclude Model 737–8 and 

Future Model 737 

Boeing requested that we revise the 

proposed AD (in the SNPRM) to exclude 

Model 737–8 airplanes and future 

Model 737 airplanes, because MOV 

actuator part number MA30A1017 

(Boeing P/N S343T003–76) is the only 

certified MOV actuator for use on any 

future Model 737 airplanes as 

documented in the drawings and 

Illustrated Parts Catalog (IPC). The 

commenter stated that using 

airworthiness limitations to prohibit the 

use of parts with AD restrictions on one 

minor model series (Model 737 next 

generation (NG) airplanes) from being 

used on a different minor model series 

(Model 737–8 and future Model 737 

airplanes) that does not allow the use of 

the restricted parts is unnecessary and 

implies that certified configurations and 

ADs can be overridden via an Advisory 

Circular (AC) or other means. 

We disagree with the commenter’s 

request. The MOV actuator currently 

allowed on Model 737–8 and 737–9 

airplanes, part number MA30A1017 


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52306 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 

(Boeing P/N S343T003–76), is the only 

part number certificated on those 

models, as documented in the 

manufacturer’s drawings. However, 

manufacturer’s proprietary drawings are 

not readily available to all affected 

operators, and there is no prohibition 

against installing MOV actuator part 

numbers that were determined unsafe in 

this AD. We have been informed by 

operators that the practice of rotating 

physically interchangeable parts among 

airplanes is widespread, and even a key 

part of their operations. In the absence 

of an AD or AWL that restricts the 

installation of the affected parts, we 

cannot be assured that the unsafe 

condition will not be introduced to 

Model 737–8, 737–9, and future 737 

airplanes. In addition, ACs are advisory 

in nature and do not include mandatory 

actions. Therefore, ACs do not take 

precedence over ADs. We have not 

changed this AD regarding this issue. 

Request To Remove Requirement To 

Revise Maintenance Program 

Boeing requested that we remove 

paragraph (j) of the proposed AD and 

revise FAA AC 120–77 or other 

applicable advisory material to preclude 

installation of equipment that both 

Boeing and the FAA have determined 

cause a potential safety issue, against 

certified configurations. Boeing 

suggested that listing parts that are not 

approved for use on a given model sets 

a precedent that can become 

unmanageable, and that identifying 

parts that are acceptable for a given 

airplane and installation position is a 

more explicit and manageable approach. 

Boeing added that the use of AWLs to 

prohibit AD-driven part installations is 

unnecessary and implies that certified 

configurations and ADs can be 

overridden via an AC or other means. 

We disagree with the commenter’s 

request. The FAA is currently 

considering revising AC 120–77 to help 

prevent the rotation of parts as a minor 

alteration. However, ACs are advisory in 

nature and do not include mandatory 

actions. Therefore, ACs cannot prohibit 

the installation of unsafe equipment, 

and they do not take precedence over 

ADs. In addition, the practice of rotating 

parts is widespread, and revising the AC 

will not improve the situation in a 

timely manner. Certain MOV actuator 

part numbers have been identified to be 

unsafe for installation at certain 

locations. Since those part numbers 

continue to be available and acceptable 

for installation at certain other 

locations, we consider the use of AWLs 

to prohibit specific parts installation to 

be a reasonable way to address the 

safety concern in a timely manner. We 

have not changed this AD regarding this 

issue. 

Request To Clarify Affected Part 

Numbers 

FedEx requested that we revise 

paragraphs (h)(2) and (h)(3) of the 

proposed AD (in the SNPRM) to state 

that no replacement is necessary if the 

MOV actuator part number is one of the 

following alternative part numbers: AV– 

31–1 (Boeing P/N S343T003–111), 

MA11A1265 (Boeing P/N S343T003– 

14), or MA11A1265–1 (Boeing P/N 

S343T003–41). FedEx stated that the 

service information specified in 

paragraphs (h)(2) and (h)(3) of the 

proposed AD (in the SNPRM) explicitly 

state that those alternative MOV 

actuator part numbers are acceptable 

substitutes for P/N MA30A1017 (Boeing 

P/N S343T003–76). 

We disagree with the commenter’s 

request. However, we agree to clarify the 

requirements of paragraphs (h)(2) and 

(h)(3) of this AD. Paragraphs (h)(2) and 

(h)(3) of this AD require replacement of 

MOV actuator P/N MA20A2027 (Boeing 

P/N S343T003–56) and P/N 

MA30A1001 (Boeing P/N S343T003–66) 

with an acceptable MOV actuator part 

number. Those paragraphs do not state 

or imply that MOV actuator P/N AV– 

31–1 (Boeing P/N S343T003–111), P/N 

MA11A1265 (Boeing P/N S343T003– 

14), or P/N MA11A1265–1 (Boeing P/N 

S343T003–41) must be replaced. 

Therefore, we consider that adding the 

proposed statement is unnecessary. We 

have not changed this AD regarding this 

issue. 

Request To Add a Terminating Action 

Provision 

FedEx requested that we revise 

paragraphs (i)(2) and (i)(3) of the 

proposed AD (in the SNPRM) to state 

that the actuator installation would 

terminate the daily functional checks 

required by AWLs 28–AWL–ENG and 

28–AWL–APU. The commenter added 

that installation of MOV actuator part 

number MA30A1017 (Boeing P/N 

S343T003–76) or an acceptable 

alternative part number should 

substantially increase the safety value. 

We disagree with the commenter’s 

request. We have determined that 

accomplishing the applicable 

maintenance or inspection program 

revisions specified in paragraph (j) of 

this AD are the appropriate terminating 

actions. As discussed previously in the 

preamble of the SNPRM, we included 

the conditions (accomplishing the 

applicable maintenance or inspection 

program revisions) that would terminate 

the requirements of AD 2015–21–10, 

Amendment 39–18303 (80 FR 65130, 

October 26, 2015); AD 2015–19–04, 

Amendment 39–18267 (80 FR 55505, 

September 16, 2015); and AD 2015–21– 

09, Amendment 39–18302 (80 FR 

65121, October 26, 2015). Those ADs 

require incorporation of the AWLs that 

require repetitive inspections of specific 

MOV actuator part numbers installed at 

specific locations. The requirements of 

those ADs may be terminated if the 

applicable conditions specified in 

paragraph (m) of this AD are met. We 

have not changed this AD regarding this 

issue. 

Request To Refer to Latest Service 

Information 

Southwest Airlines requested that we 

refer to the latest revisions of the 

airworthiness limitations documents. 

We agree with the commenter’s 

request and have revised this AD to 

refer to the current airworthiness 

limitations as the appropriate source of 

service information, and have included 

earlier revisions of the service 

information as credit in this AD. There 

are no changes to the required actions 

of this AD because the tasks that must 

be incorporated into the maintenance or 

inspection program are not changed in 

Boeing 737–600/700/700C/800/900/ 

900ER Special Compliance Items/ 

Airworthiness Limitations, D626A001– 

9–04, Revision June 2018; Boeing 757 

Maintenance Planning Data (MPD) 

Document, Section 9, Airworthiness 

Limitations (AWLS) and Certification 

Maintenance Requirements (CMRs), 

D622N001–9, Revision May 2018; or 

Boeing 767–200/300/300F/400 Special 

Compliance Items/Airworthiness 

Limitations, D622T001–9–04, Revision 

March 2018; except for Task 28–AWL– 

23 for Model 767–200, –300, –300F, and 

–400ER series airplanes, which adds 

instructions that further describe the 

conditions for performing electrical 

bonding resistance measurements, in 

addition to being more descriptive 

regarding cap seal application. 

Conclusion 

We reviewed the relevant data, 

considered the comments received, and 

determined that air safety and the 

public interest require adopting this 

final rule with the changes described 

previously and minor editorial changes. 

We have determined that these minor 

changes: 

• Are consistent with the intent that 

was proposed in the SNPRM for 

addressing the unsafe condition; and 

• Do not add any additional burden 

upon the public than was already 

proposed in the SNPRM. 

We also determined that these 

changes will not increase the economic 


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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 52307 

burden on any operator or increase the 

scope of this final rule. 

Related Service Information Under 1 

CFR Part 51 

We reviewed the following service 

information. 

• Boeing Service Bulletin 737–28– 

1314, dated November 17, 2014, 

describes procedures for installing new 

MOV actuators of the fuel shutoff valves 

for the left and right engines on Model 

737–600, –700, –700C, –800, –900, and 

–900ER series airplanes. 

• Boeing 737–600/700/700C/800/900/ 

900ER Special Compliance Items/ 

Airworthiness Limitations, D626A001– 

9–04, Revision June 2018, describes 

AWLs for fuel tank ignition prevention 

on Model 737–600, –700, –700C, –800, 

–900, and –900ER series airplanes. 

• Boeing Special Attention Service 

Bulletin 757–28–0138, Revision 1, dated 

June 19, 2017, describes procedures for 

installing new MOV actuators of the fuel 

shutoff valves for the left and right 

engines, and of the APU fuel shutoff 

valve, on Model 757 airplanes. 

• Boeing 757 Maintenance Planning 

Data (MPD) Document, Section 9, 

Airworthiness Limitations (AWLs) and 

Certification Maintenance Requirements 

(CMRs), D622N001–9, Revision May 

2018, describes AWLs for fuel tank 

ignition prevention on Model 757 

airplanes. 

• Boeing Service Bulletin 767–28– 

0115, Revision 1, dated June 2, 2016, 

describes procedures for installing new 

MOV actuators of the fuel shutoff valves 

for the left and right engines, and of the 

APU fuel shutoff valve, on Model 767 

airplanes. 

• Boeing 767–200/300/300F/400 

Special Compliance Items/ 

Airworthiness Limitations, D622T001– 

9–04, Revision March 2018, describes 

AWLs for fuel tank ignition prevention 

on Model 767 airplanes. 

This service information 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 

We estimate that this AD affects 2,557 

airplanes of U.S. registry. We estimate 

the following costs to comply with this 

AD: 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per product Cost on U.S. operators 

Inspection and replacement Model 737 (1,440 

airplanes).

Up to 6 work-hours × $85 

per hour = Up to $510.

Up to $12,000 ................... Up to $12,510 ................... Up to $18,014,400. 

Inspection and replacement Model 757 (675 

airplanes).

Up to 9 work-hours × $85 

per hour = Up to $765.

Up to $18,000 ................... Up to $18,765 ................... Up to $12,666,375. 

Inspection and replacement Model 767 (442 

airplanes).

Up to 9 work-hours × $85 

per hour = Up to $765.

Up to $18,000 ................... Up to $18,765 ................... Up to $8,294,130. 

For the maintenance/inspection 

program revision, we have determined 

that this action takes an average of 90 

work-hours per operator, although we 

recognize that this number may vary 

from operator to operator. In the past, 

we have estimated that this action takes 

1 work-hour per airplane. Since 

operators incorporate maintenance or 

inspection program changes for their 

affected fleets, we have determined that 

a per-operator estimate is more accurate 

than a per-airplane estimate. Therefore, 

we estimate the total cost per operator 

to be $7,650 (90 work-hours × $85 per 

work-hour). 

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. 

We are 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 develop on 

products identified in this rulemaking 

action. 

This AD is issued in accordance with 

authority delegated by the Executive 

Director, Aircraft Certification Service, 

as authorized by FAA Order 8000.51C. 

In accordance with that order, issuance 

of ADs is normally a function of the 

Compliance and Airworthiness 

Division, but during this transition 

period, the Executive Director has 

delegated the authority to issue ADs 

applicable to transport category 

airplanes and associated appliances to 

the Director of the System Oversight 

Division. 

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) Is not a ‘‘significant rule’’ under 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) 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. 

Adoption of 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. 


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52308 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2018–20–13 The Boeing Company: 

Amendment 39–19447; Docket No. 

FAA–2017–0127; Product Identifier 

2016–NM–161–AD. 

(a) Effective Date 

This AD is effective November 15, 2018. 

(b) Affected ADs 

This AD affects AD 2015–21–09, 

Amendment 39–18302 (80 FR 65121, October 

26, 2015) (‘‘AD 2015–21–09’’); AD 2015–19– 

04, Amendment 39–18267, (80 FR 55505, 

September 16, 2015) (‘‘AD 2015–19–04’’); 

and AD 2015–21–10, Amendment 39–18303 

(80 FR 65130, October 26, 2015) (‘‘AD 2015– 

21–10’’). 

(c) Applicability 

This AD applies to all The Boeing 

Company airplanes, certificated in any 

category, identified in paragraphs (c)(1), 

(c)(2), and (c)(3) of this AD. 

(1) Model 737 airplanes, excluding Model 

737–100, –200, –200C, –300, –400, and –500 

series airplanes. 

(2) Model 757–200, –200PF, –200CB, and 

–300 series airplanes. 

(3) Model 767–200, –300, –300F, and 

–400ER series airplanes. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 28; Fuel. 

(e) Unsafe Condition 

This AD was prompted by reports of 

latently failed motor-operated valve (MOV) 

actuators of the fuel shutoff valves. We are 

issuing this AD to prevent a latent failure of 

the actuator for the engine or auxiliary power 

unit (APU) fuel shutoff valves, which could 

result in the inability to shut off fuel to the 

engine or the APU, and, in case of certain 

engine or APU fires, could result in structural 

failure. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Inspection To Determine Part Number 

(P/N) 

(1) For Model 737–600, –700, –700C, –800, 

–900, and –900ER series airplanes: Within 8 

years after the effective date of this AD, do 

an inspection to determine the part numbers 

of the MOV actuators of the fuel shutoff 

valves for the left and right engines, in 

accordance with the Accomplishment 

Instructions of Boeing Service Bulletin 737– 

28–1314, dated November 17, 2014. A review 

of airplane maintenance records is acceptable 

in lieu of this inspection if the part number 

of the MOV actuator at each location can be 

conclusively determined from that review. 

(2) For airplanes identified in paragraphs 

(c)(2) and (c)(3) of this AD: Within 8 years 

after the effective date of this AD, do an 

inspection to determine the part numbers of 

the MOV actuators of the fuel shutoff valves 

for the left and right engines, and of the APU 

fuel shutoff valve, in accordance with the 

Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 757–28– 

0138, Revision 1, dated June 19, 2017 (‘‘SB 

757–28–0138 R1’’); or Boeing Service 

Bulletin 767–28–0115, Revision 1, dated June 

2, 2016 (‘‘SB 767–28–0115 R1’’); as 

applicable. A review of airplane maintenance 

records is acceptable in lieu of this 

inspection if the part number of the MOV 

actuator at each location can be conclusively 

determined from that review. 

(h) Replacement 

(1) For Model 737–600, –700, –700C, –800, 

–900, and –900ER series airplanes on which 

any MOV actuator having P/N MA20A2027 

or P/N MA30A1001 (Boeing P/N S343T003– 

56 or Boeing P/N S343T003–66, 

respectively), is found during the inspection 

required by paragraph (g)(1) of this AD: 

Within 8 years after the effective date of this 

AD, replace each affected MOV actuator with 

an MOV actuator having P/N MA30A1017 

(Boeing P/N S343T003–76), in accordance 

with the Accomplishment Instructions of 

Boeing Service Bulletin 737–28–1314, dated 

November 17, 2014. Where Boeing Service 

Bulletin 737–28–1314, dated November 17, 

2014, specifies the installation of a new MOV 

actuator, this AD allows the installation of a 

new or serviceable MOV actuator. While not 

required by this AD, the Accomplishment 

Instructions specified in Boeing Service 

Bulletin 737–28–1314, dated November 17, 

2014, for replacing MOV actuators having 

Boeing P/N S343T003–66 or Boeing P/N 

S343T003–56 may be used for replacing 

MOV actuators having P/N MA20A1001–1 

(Boeing P/N S343T003–39). 

(2) For airplanes identified in paragraph 

(c)(2) of this AD on which any MOV actuator 

having P/N MA20A2027 or P/N MA30A1001 

(Boeing P/N S343T003–56 or Boeing P/N 

S343T003–66, respectively) is found during 

the inspection required by paragraph (g)(2) of 

this AD: Within 8 years after the effective 

date of this AD, replace each affected MOV 

actuator with an MOV actuator having P/N 

MA30A1017 (Boeing P/N S343T003–76), P/N 

AV–31–1 (Boeing P/N S343T003–111), or P/ 

N MA11A1265–1 (Boeing P/N S343T003–41), 

in accordance with the Accomplishment 

Instructions of SB 757–28–0138 R1. Where 

SB 757–28–0138 R1 specifies the installation 

of a new MOV actuator, this AD allows the 

installation of a new or serviceable MOV 

actuator. While not required by this AD, the 

Accomplishment Instructions specified in SB 

757–28–0138 R1 for replacing MOV actuators 

having Boeing P/N S343T003–66 or Boeing 

P/N S343T003–56 may be used for replacing 

MOV actuators having P/N MA20A1001–1 

(Boeing P/N S343T003–39). 

(3) For airplanes identified in paragraph 

(c)(3) of this AD on which any MOV actuator 

having P/N MA20A2027 (Boeing P/N 

S343T003–56) or P/N MA30A1001 (Boeing 

P/N S343T003–66) is found during the 

inspection required by paragraph (g)(2) of 

this AD: Within 8 years after the effective 

date of this AD, replace each affected MOV 

actuator with an MOV actuator having P/N 

MA30A1017 (Boeing P/N S343T003–76), P/N 

AV–31–1 (Boeing P/N S343T003–111), P/N 

MA11A1265 (Boeing P/N S343T003–14), or 

P/N MA11A1265–1 (Boeing P/N S343T003– 

41), in accordance with the Accomplishment 

Instructions of SB 767–28–0115 R1. Where 

SB 767–28–0115 R1 specifies the installation 

of a new MOV actuator, this AD allows the 

installation of a new or serviceable MOV 

actuator. While not required by this AD, the 

Accomplishment Instructions specified in SB 

767–28–0115 R1, for replacing MOV 

actuators having Boeing P/N S343T003–66 or 

Boeing P/N S343T003–56 may be used for 

replacing MOV actuators having P/N 

MA20A1001–1 (Boeing P/N S343T003–39). 

(i) Maintenance or Inspection Program 

Revision 

(1) For Model 737–600, –700, –700C, –800, 

–900, and –900ER series airplanes with an 

original certificate of airworthiness or 

original export certificate of airworthiness 

issued on or before the effective date of this 

AD: Prior to or concurrently with the actions 

required by paragraph (h)(1) of this AD or 

within 30 days after the effective date of this 

AD, whichever is later, revise the 

maintenance or inspection program, as 

applicable, to add the airworthiness 

limitations (AWLs) specified in paragraphs 

(i)(1)(i), (i)(1)(ii), and (i)(1)(iii) of this AD. 

The initial compliance time for 

accomplishing the actions required by AWL 

No. 28–AWL–24 is within 6 years since the 

most recent inspection was performed in 

accordance with AWL No. 28–AWL–24, or 

within 6 years since the actions specified in 

Boeing Alert Service Bulletin 737–28A1207 

were accomplished, whichever is later. 

(i) AWL No. 28–AWL–21, Motor Operated 

Valve (MOV) Actuator—Lightning and Fault 

Current Protection Electrical Bond, as 

specified in Boeing 737–600/700/700C/800/ 

900/900ER Special Compliance Items/ 

Airworthiness Limitations, D626A001–9–04, 

Revision June 2018. 

(ii) AWL No. 28–AWL–22, Motor Operated 

Valve (MOV) Actuator—Electrical Design 

Feature, as specified in Boeing 737–600/700/ 

700C/800/900/900ER Special Compliance 

Items/Airworthiness Limitations, D626A001– 

9–04, Revision June 2018. 

(iii) AWL No. 28–AWL–24, Spar Valve 

Motor Operated Valve (MOV) Actuator— 

Lightning and Fault Current Protection 

Electrical Bond, as specified in Boeing 737– 

600/700/700C/800/900/900ER Special 

Compliance Items/Airworthiness 

Limitations, D626A001–9–04, Revision June 

2018. 

(2) For airplanes identified in paragraph 

(c)(2) of this AD: Prior to or concurrently 

with the actions required by paragraph (h)(2) 

of this AD, revise the maintenance or 

inspection program, as applicable, to add the 

AWLs specified in paragraphs (i)(2)(i), 

(i)(2)(ii), and (i)(2)(iii) of this AD. The initial 

compliance time for accomplishing the 

actions required by AWL No. 28–AWL–25 is 

within 6 years since the most recent 

inspection was performed in accordance with 

AWL No. 28–AWL–25, or within 6 years 

since the actions specified in Boeing Alert 

Service Bulletin 757–28A0088 were 

accomplished, whichever is later. 

(i) AWL No. 28–AWL–23, Motor Operated 

Valve (MOV) Actuator—Lightning and Fault 


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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 52309 

Current Protection Electrical Bond, as 

specified in Boeing 757 Maintenance 

Planning Data (MPD) Document, Section 9, 

Airworthiness Limitations (AWLs) and 

Certification Maintenance Requirements 

(CMRs), D622N001–9, Revision May 2018. 

(ii) AWL No. 28–AWL–24, MOV 

Actuator—Electrical Design Feature, as 

specified in Boeing 757 Maintenance 

Planning Data (MPD) Document, Section 9, 

Airworthiness Limitations (AWLs) and 

Certification Maintenance Requirements 

(CMRs), D622N001–9, Revision May 2018. 

(iii) AWL No. 28–AWL–25, Motor 

Operated Valve (MOV) Actuator—Lightning 

and Fault Current Protection Electrical Bond, 

as specified in Boeing 757 Maintenance 

Planning Data (MPD) Document, Section 9, 

Airworthiness Limitations (AWLs) and 

Certification Maintenance Requirements 

(CMRs), D622N001–9, Revision May 2018. 

(3) For airplanes identified in paragraph 

(c)(3) of this AD with an original certificate 

of airworthiness or original export certificate 

of airworthiness issued on or before the 

effective date of this AD: Prior to or 

concurrently with the actions required by 

paragraph (h)(3) of this AD, revise the 

maintenance or inspection program, as 

applicable, to add the AWLs specified in 

paragraphs (i)(3)(i) and (i)(3)(ii) of this AD. 

(i) AWL No. 28–AWL–23, Motor Operated 

Valve (MOV) Actuator—Lightning and Fault 

Current Protection Electrical Bond, as 

specified in Boeing 767–200/300/300F/400 

Special Compliance Items/Airworthiness 

Limitations, D622T001–9–04, Revision 

March 2018. 

(ii) AWL No. 28–AWL–24, Motor Operated 

Valve (MOV) Actuator—Electrical Design 

Feature, as specified in Boeing 767–200/300/ 

300F/400 Special Compliance Items/ 

Airworthiness Limitations, D622T001–9–04, 

Revision March 2018. 

(j) Maintenance or Inspection Program 

Revision for Parts Installation Prohibition 

(1) For Model 737–600, –700, –700C, –800, 

–900, and –900ER series airplanes: After 

accomplishing the actions required by 

paragraphs (g)(1), (h)(1), and (i)(1) of this AD, 

as applicable, on all airplanes in an 

operator’s fleet, and within 8 years after the 

effective date of the AD, revise the 

maintenance or inspection program, as 

applicable, by incorporating the AWL 

specified in figure 1 to paragraph (j)(1) of this 

AD. 

BILLING CODE 1301–00–D 

(2) For airplanes identified in paragraph 

(c)(2) of this AD: After accomplishing the 

actions required by paragraphs (g)(2), (h)(2), 

and (i)(2) of this AD, as applicable, on all 

airplanes in an operator’s fleet, and within 8 

years after the effective date of the AD, revise 

the maintenance or inspection program, as 

applicable, by incorporating the AWL 

specified in figure 2 to paragraph (j)(2) of this 

AD. 


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52310 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 

(3) For airplanes identified in paragraph 

(c)(3) of this AD: After accomplishing the 

actions required by paragraphs (g)(2), (h)(3), 

and (i)(3) of this AD, as applicable, on all 

airplanes in an operator’s fleet, and within 8 

years after the effective date of the AD, revise 

the maintenance or inspection program, as 

applicable, by incorporating the AWL 

specified in figure 3 to paragraph (j)(3) of this 

AD. 

(4) For airplanes identified in paragraph 

(c)(1) of this AD, excluding Model 737–600, 

–700, –700C, –800, –900, and –900ER series 

airplanes: Within 30 days since the date of 

issuance of the original standard 

airworthiness certificate or the date of 

issuance of the original export certificate of 

airworthiness, or within 30 days after the 

effective date of this AD, whichever is later, 

revise the maintenance or inspection 

program, as applicable, by incorporating the 

AWL specified in figure 4 to paragraph (j)(4) 

of this AD. 


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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 52311 

BILLING CODE 1301–00–C 

(k) No Alternative Actions, Intervals, and 

Critical Design Configuration Control 

Limitations (CDCCLs) 

(1) After the maintenance or inspection 

program has been revised as required by 

paragraph (i) of this AD, no alternative 

actions (e.g., inspections), intervals, or 

CDCCLs, may be used unless the actions, 

intervals, and CDCCLs are approved as an 

alternative method of compliance (AMOC) in 

accordance with the procedures specified in 

paragraph (o) of this AD. 

(2) After the maintenance or inspection 

program has been revised as required by 

paragraph (j) of this AD, no alternative 

actions (e.g., inspections), intervals, or 

CDCCLs, may be used unless the actions, 

intervals, and CDCCLs are approved as an 

AMOC in accordance with the procedures 

specified in paragraph (o) of this AD. 

(l) Parts Installation Prohibition 

(1) For Model 737–600, –700, –700C, –800, 

–900, and –900ER series airplanes: As of the 

effective date of this AD, no person may 

replace an MOV actuator having P/N 

MA30A1017 (Boeing P/N S343T003–76) with 

an MOV actuator having P/N MA20A2027 or 

P/N MA30A1001 (Boeing P/N S343T003–56 

or Boeing P/N S343T003–66, respectively) for 

the left engine and right engine fuel shutoff 

valves. 

(2) For airplanes identified in paragraph 

(c)(2) of this AD: As of the effective date of 

this AD, no person may replace an MOV 

actuator having P/N AV–31–1 (Boeing P/N 

S343T003–111), P/N MA11A1265 (Boeing P/ 

N S343T003–14), P/N MA11A1265–1 (Boeing 

P/N S343T003–41), or P/N MA30A1017 

(Boeing P/N S343T003–76) with an MOV 

actuator having P/N MA30A1001 (Boeing 

P/N S343T003–66) or P/N MA20A2027 

(Boeing P/N S343T003–56) for the left engine 

and right engine fuel shutoff valves and the 

APU fuel shutoff valve. 

(3) For airplanes identified in paragraph 

(c)(3) of this AD: As of the effective date of 

this AD, no person may replace an MOV 

actuator having P/N AV–31–1 (Boeing P/N 

S343T003–111), P/N MA11A1265 (Boeing P/ 

N S343T003–14), P/N MA11A1265–1 (Boeing 

P/N S343T003–41), or P/N MA30A1017 

(Boeing P/N S343T003–76) with an MOV 

actuator having P/N MA30A1001 (Boeing 

P/N S343T003–66) or P/N MA20A2027 

(Boeing P/N S343T003–56) for the left engine 

and right engine fuel shutoff valves and the 

APU fuel shutoff valve. 


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52312 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 

(4) For airplanes identified in paragraph 

(c)(1) of this AD, excluding Model 737–600, 

–700, –700C, –800, –900, and –900ER series 

airplanes: As of the effective date of this AD, 

no person may install an MOV actuator 

having P/N MA20A1001–1 (Boeing P/N 

S343T003–39) or replace an MOV actuator 

with an MOV actuator having P/N 

MA20A2027 or P/N MA30A1001 (Boeing 

P/N S343T003–56 or Boeing P/N S343T003– 

66, respectively) for the left engine and right 

engine fuel shutoff valves. 

(m) Terminating Action 

(1) For Model 737–600, –700, –700C, –800, 

–900, and –900ER series airplanes: 

Accomplishing the actions required by 

paragraph (j)(l) of this AD terminates the 

requirements of paragraph (l)(1) of this AD 

and all requirements of AD 2015–21–10. 

(2) For airplanes identified in paragraph 

(c)(2) of this AD: Accomplishing the action 

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

terminates the requirements of paragraph 

(l)(2) of this AD and all requirements of AD 

2015–19–04. 

(3) For airplanes identified in paragraph 

(c)(3) of this AD: Accomplishing the action 

required by paragraph (j)(3) of this AD 

terminates the requirements of paragraph 

(l)(3) of this AD and all requirements of AD 

2015–21–09. 

(4) For airplanes identified in paragraph 

(c)(1) of this AD, excluding Model 737–600, 

–700, –700C, –800, –900, and –900ER series 

airplanes: Accomplishing the action required 

by paragraph (j)(4) of this AD terminates the 

requirements of paragraph (l)(4) of this AD. 

(n) Credit for Previous Actions 

(1) This paragraph provides credit for the 

actions specified in paragraph (g)(2) or (h)(2) 

of this AD, as applicable, if those actions 

were performed before the effective date of 

this AD using Boeing Special Attention 

Service Bulletin 757–28–0138, dated May 18, 

2016. 

(2) This paragraph provides credit for the 

actions specified in paragraph (g)(2) or (h)(3) 

of this AD, as applicable, if those actions 

were performed before the effective date of 

this AD using Boeing Service Bulletin 767– 

28–0115, dated September 10, 2015. 

(3) For Model 737–600, –700, –700C, –800, 

–900, and –900ER series airplanes with an 

original certificate of airworthiness or 

original export certificate of airworthiness 

issued on or before the effective date of this 

AD, this paragraph provides credit for the 

actions specified in paragraph (i)(1) of this 

AD if those actions were performed before 

the effective date of this AD using Boeing 

737–600/700/700C/800/900/900ER Special 

Compliance Items/Airworthiness 

Limitations, D626A001–9–04, Revision July 

2016, Revision September 2016, Revision 

January 2017, Revision April 2018, or 

Revision May 2018; or Boeing 737–600/700/ 

700C/800/900/900ER Maintenance Planning 

Data (MPD) Document, Section 9, 

Airworthiness Limitations (AWLs) and 

Certification Maintenance Requirements 

(CMRs), D626A001–CMR, Revision October 

2014, Revision November 2014, Revision 

January 2015, or Revision April 2016. 

(4) For airplanes identified in paragraph 

(c)(2) of this AD, this paragraph provides 

credit for the actions specified in paragraph 

(i)(2) of this AD if those actions were 

performed before the effective date of this AD 

using Boeing 757 Maintenance Planning Data 

(MPD) Document, Section 9, Airworthiness 

Limitations (AWLs) and Certification 

Maintenance Requirements (CMRs), 

D622N001–9, Revision January 2016, 

Revision July 2016, or Revision February 

2017. 

(5) For airplanes identified in paragraph 

(c)(3) of this AD with an original certificate 

of airworthiness or original export certificate 

of airworthiness issued on or before the 

effective date of this AD, this paragraph 

provides credit for the actions specified in 

paragraph (i)(3) of this AD if those actions 

were performed before the effective date of 

this AD using Boeing 767 Special 

Compliance Items/Airworthiness 

Limitations, D622T001–9–04, Revision July 

2015, Revision March 2016, Revision May 

2016, Revision May 2016 R1, or Revision 

June 2016; or Boeing 767–200/300/300F/400 

Special Compliance Items/Airworthiness 

Limitations, D622T001–9–04, Revision 

January 2018. 

(6) For airplanes identified in paragraph 

(c)(3) of this AD with an original certificate 

of airworthiness or original export certificate 

of airworthiness issued on or before the 

effective date of this AD, this paragraph 

provides credit for the actions specified in 

paragraph (i)(3)(ii) of this AD if those actions 

were performed before the effective date of 

this AD using Boeing 767 Special 

Compliance Items/Airworthiness 

Limitations, D622T001–9–04, Revision 

October 2014. 

(o) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle ACO 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 

certification office, send it to the attention of 

the person identified in paragraph (p)(1) of 

this AD. Information may be emailed to: 9- 

ANM-Seattle-ACO-AMOC-Requests@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. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair, 

modification, or alteration required by this 

AD if it is approved by the Boeing 

Commercial Airplanes Organization 

Designation Authorization (ODA) that has 

been authorized by the Manager, Seattle ACO 

Branch, to make those findings. To be 

approved, the repair method, modification 

deviation, or alteration deviation must meet 

the certification basis of the airplane, and the 

approval must specifically refer to this AD. 

(4) For service information that contains 

steps that are labeled as Required for 

Compliance (RC), the provisions of 

paragraphs (o)(4)(i) and (o)(4)(ii) of this AD 

apply. 

(i) The steps labeled as RC, including 

substeps under an RC step and any figures 

identified in an RC step, must be done to 

comply with the AD. If a step or substep is 

labeled ‘‘RC Exempt,’’ then the RC 

requirement is removed from that step or 

substep. An AMOC is required for any 

deviations to RC steps, including substeps 

and identified figures. 

(ii) Steps not labeled as RC may be 

deviated from using accepted methods in 

accordance with the operator’s maintenance 

or inspection program without obtaining 

approval of an AMOC, provided the RC steps, 

including substeps and identified figures, can 

still be done as specified, and the airplane 

can be put back in an airworthy condition. 

(p) Related Information 

(1) For more information about this AD, 

contact Tak Kobayashi, Aerospace Engineer, 

Propulsion Section, FAA, Seattle ACO 

Branch, 2200 South 216th St., Des Moines, 

WA 98198; phone and fax: 206–231–3553; 

email: Takahisa.Kobayashi@faa.gov. 

(2) Service information identified in this 

AD that is not incorporated by reference is 

available at the addresses specified in 

paragraphs (q)(3) and (q)(4) of this AD. 

(q) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) Boeing 737–600/700/700C/800/900/ 

900ER Special Compliance Items/ 

Airworthiness Limitations, D626A001–9–04, 

Revision June 2018. 

(ii) Boeing 757 Maintenance Planning Data 

(MPD) Document, Section 9, Airworthiness 

Limitations (AWLs) and Certification 

Maintenance Requirements (CMRs), 

D622N001–9, Revision May 2018. 

(iii) Boeing 767–200/300/300F/400ER 

Special Compliance Items/Airworthiness 

Limitations, D622T001–9–04, Revision 

March 2018. 

(iv) Boeing Service Bulletin 737–28–1314, 

dated November 17, 2014. 

(v) Boeing Service Bulletin 767–28–0115, 

Revision 1, dated June 2, 2016. 

(vi) Boeing Special Attention Service 

Bulletin 757–28–0138, Revision 1, dated June 

19, 2017. 

(3) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Contractual & Data 

Services (C&DS), 2600 Westminster Blvd., 

MC 110–SK57, Seal Beach, CA 90740–5600; 

telephone: 562–797–1717; internet: https://

www.myboeingfleet.com. 

(4) You may view this service information 

at the FAA, Transport Standards Branch, 

2200 South 216th St., Des Moines, WA. For 

information on the availability of this 

material at the FAA, call 206–231–3195. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 


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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Rules and Regulations 52313 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Des Moines, Washington, on 

September 14, 2018. 

John P. Piccola, 

Acting Director, System Oversight Division, 

Aircraft Certification Service. 

[FR Doc. R1–2018–21460 Filed 10–16–18; 8:45 am] 

BILLING CODE 1301–00–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2018–N–3596] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Herpes Virus Nucleic Acid-Based 

Cutaneous and Mucocutaneous Lesion 

Panel 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the herpes virus nucleic 

acid-based cutaneous and 

mucocutaneous lesion panel 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 herpes 

virus nucleic acid-based cutaneous and 

mucocutaneous lesion panel’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, 

in part by reducing regulatory burdens. 

DATES: This order is effective October 

17, 2018. The classification was 

applicable on May 13, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Scott McFarland, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4676, Silver Spring, 

MD, 20993–0002, 301–796–6217, 

scott.mcfarland@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

herpes virus nucleic acid-based 

cutaneous and mucocutaneous lesion 

panel 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 

reducing regulatory burdens 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 (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 

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). 

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. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation, in part by 

reducing regulatory burdens. 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 21 

U.S.C. 360c(f)(2)(B)(i)). 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 21 

U.S.C. 360c(i), 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 February 7, 2014, finding the LyraTM

Direct HSV 1 + 2/VZV Assay 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 February 21, 2014, Quidel 

Corporation submitted a request for De 

Novo classification of the LyraTM Direct 

HSV 1 + 2/VZV Assay. 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 general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on May 13, 2014, FDA 

issued an order to the requestor 

classifying the device into class II. FDA 


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