Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40971 

AIRAC date State City Airport FDC No. FDC date Subject 

13-Sep-18 ....... FL Fort Lauderdale ..... Fort Lauderdale/Hollywood 

Intl.

8/8174 7/10/18 ILS OR LOC RWY 10L, Amdt 24. 

13-Sep-18 ....... FL Fort Lauderdale ..... Fort Lauderdale/Hollywood 

Intl.

8/8183 7/10/18 ILS OR LOC RWY 10R, Amdt 1. 

13-Sep-18 ....... FL Fort Lauderdale ..... Fort Lauderdale/Hollywood 

Intl.

8/8189 7/10/18 ILS OR LOC RWY 28R, Amdt 

11. 

13-Sep-18 ....... FL Fort Lauderdale ..... Fort Lauderdale/Hollywood 

Intl.

8/8201 7/10/18 RNAV (GPS) RWY 10R, Amdt 1. 

13-Sep-18 ....... FL Fort Lauderdale ..... Fort Lauderdale/Hollywood 

Intl.

8/8211 7/10/18 RNAV (GPS) RWY 28L, Amdt 1. 

13-Sep-18 ....... FL Fort Lauderdale ..... Fort Lauderdale/Hollywood 

Intl.

8/8232 7/10/18 RNAV (RNP) Y RWY 10L, Amdt 

1A. 

13-Sep-18 ....... FL Fort Lauderdale ..... Fort Lauderdale/Hollywood 

Intl.

8/8240 7/10/18 RNAV (GPS) Y RWY 28R, Amdt 

4. 

13-Sep-18 ....... FL Fort Lauderdale ..... Fort Lauderdale/Hollywood 

Intl.

8/8244 7/10/18 RNAV (GPS) Z RWY 10L, Amdt 

4. 

13-Sep-18 ....... GA Calhoun ................. Tom B David Fld .................... 8/8262 7/23/18 RNAV (GPS) RWY 35, Amdt 1B. 

13-Sep-18 ....... GA Calhoun ................. Tom B David Fld .................... 8/8265 7/23/18 RNAV (GPS) RWY 17, Amdt 1A. 

13-Sep-18 ....... AL Mobile .................... Mobile Downtown .................. 8/8670 7/10/18 RNAV (GPS) RWY 14, Amdt 2. 

13-Sep-18 ....... NJ Ocean City ............. Ocean City Muni .................... 8/8675 7/10/18 GPS RWY 6, Orig-B. 

13-Sep-18 ....... NJ Ocean City ............. Ocean City Muni .................... 8/8676 7/10/18 VOR–A, Orig-B. 

13-Sep-18 ....... TX Houston ................. David Wayne Hooks Memorial.8/8861 7/25/18 RNAV (GPS) RWY 35L, Amdt 

1C. 

13-Sep-18 ....... TX Houston ................. David Wayne Hooks Memorial.8/8862 7/25/18 RNAV (GPS) RWY 17R, Amdt 

1D. 

13-Sep-18 ....... TX Houston ................. David Wayne Hooks Memorial.8/8863 7/25/18 LOC RWY 17R, Amdt 3D. 

13-Sep-18 ....... OK Oklahoma City ....... Will Rogers World .................. 8/9620 7/23/18 VOR RWY 17L, Amdt 2. 

13-Sep-18 ....... KS Independence ........ Independence Muni ............... 8/9691 7/23/18 RNAV (GPS) RWY 17, Amdt 2. 

13-Sep-18 ....... MN Moose Lake ........... Moose Lake Carlton County .. 8/9703 7/25/18 NDB RWY 4, Amdt 1. 

[FR Doc. 2018–17616 Filed 8–16–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 31206; Amdt. No. 3811] 

Standard Instrument Approach 

Procedures, and Takeoff Minimums 

and Obstacle Departure Procedures; 

Miscellaneous Amendments 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This rule establishes, amends, 

suspends, or removes Standard 

Instrument Approach Procedures 

(SIAPs) and associated Takeoff 

Minimums and Obstacle Departure 

Procedures (ODPs) for operations at 

certain airports. These regulatory 

actions are needed because of the 

adoption of new or revised criteria, or 

because of changes occurring in the 

National Airspace System, such as the 

commissioning of new navigational 

facilities, adding new obstacles, or 

changing air traffic requirements. These 

changes are designed to provide safe 

and efficient use of the navigable 

airspace and to promote safe flight 

operations under instrument flight rules 

at the affected airports. 

DATES: This rule is effective August 17, 

2018. The compliance date for each 

SIAP, associated Takeoff Minimums, 

and ODP is specified in the amendatory 

provisions. 

The incorporation by reference of 

certain publications listed in the 

regulations is approved by the Director 

of the Federal Register as of August 17, 

2018. 

ADDRESSES: Availability of matters 

incorporated by reference in the 

amendment is as follows: 

For Examination 

1. U.S. Department of Transportation, 

Docket Ops–M30, 1200 New Jersey 

Avenue SE, West Bldg., Ground Floor, 

Washington, DC 20590–0001. 

2. The FAA Air Traffic Organization 

Service Area in which the affected 

airport is located; 

3. The office of Aeronautical 

Navigation Products, 6500 South 

MacArthur Blvd., Oklahoma City, OK 

73169 or, 

4. The National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal_register/code_of_federal_

regulations/ibr_locations.html. 

Availability 

All SIAPs and Takeoff Minimums and 

ODPs are available online free of charge. 

Visit the National Flight Data Center at 

nfdc.faa.gov to register. Additionally, 

individual SIAP and Takeoff Minimums 

and ODP copies may be obtained from 

the FAA Air Traffic Organization 

Service Area in which the affected 

airport is located. 

FOR FURTHER INFORMATION CONTACT: 

Thomas J. Nichols, Flight Procedure 

Standards Branch (AFS–420), Flight 

Technologies and Programs Divisions, 

Flight Standards Service, Federal 

Aviation Administration, Mike 

Monroney Aeronautical Center, 6500 

South MacArthur Blvd., Oklahoma City, 

OK 73169 (Mail Address: P.O. Box 

25082, Oklahoma City, OK 73125) 

Telephone: (405) 954–4164. 

SUPPLEMENTARY INFORMATION: This rule 

amends Title 14 of the Code of Federal 

Regulations, part 97 (14 CFR part 97), by 

establishing, amending, suspending, or 

removes SIAPS, Takeoff Minimums 

and/or ODPS. The complete regulatory 

description of each SIAP and its 

associated Takeoff Minimums or ODP 

for an identified airport is listed on FAA 

form documents which are incorporated 

by reference in this amendment under 5 

U.S.C. 552(a), 1 CFR part 51, and 14 

CFR part 97.20. The applicable FAA 

forms are FAA Forms 8260–3, 8260–4, 


daltland on DSKBBV9HB2PROD with RULES
40972 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

8260–5, 8260–15A, and 8260–15B when 

required by an entry on 8260–15A. 

The large number of SIAPs, Takeoff 

Minimums and ODPs, their complex 

nature, and the need for a special format 

make publication in the Federal 

Register expensive and impractical. 

Further, airmen do not use the 

regulatory text of the SIAPs, Takeoff 

Minimums or ODPs, but instead refer to 

their graphic depiction on charts 

printed by publishers of aeronautical 

materials. Thus, the advantages of 

incorporation by reference are realized 

and publication of the complete 

description of each SIAP, Takeoff 

Minimums and ODP listed on FAA form 

documents is unnecessary. This 

amendment provides the affected CFR 

sections and specifies the types of 

SIAPs, Takeoff Minimums and ODPs 

with their applicable effective dates. 

This amendment also identifies the 

airport and its location, the procedure, 

and the amendment number. 

Availability and Summary of Material 

Incorporated by Reference 

The material incorporated by 

reference is publicly available as listed 

in the ADDRESSES section. 

The material incorporated by 

reference describes SIAPS, Takeoff 

Minimums and/or ODPS as identified in 

the amendatory language for part 97 of 

this final rule. 

The Rule 

This amendment to 14 CFR part 97 is 

effective upon publication of each 

separate SIAP, Takeoff Minimums and 

ODP as Amended in the transmittal. 

Some SIAP and Takeoff Minimums and 

textual ODP amendments may have 

been issued previously by the FAA in a 

Flight Data Center (FDC) Notice to 

Airmen (NOTAM) as an emergency 

action of immediate flight safety relating 

directly to published aeronautical 

charts. 

The circumstances that created the 

need for some SIAP and Takeoff 

Minimums and ODP amendments may 

require making them effective in less 

than 30 days. For the remaining SIAPs 

and Takeoff Minimums and ODPs, an 

effective date at least 30 days after 

publication is provided. 

Further, the SIAPs and Takeoff 

Minimums and ODPs contained in this 

amendment are based on the criteria 

contained in the U.S. Standard for 

Terminal Instrument Procedures 

(TERPS). In developing these SIAPs and 

Takeoff Minimums and ODPs, the 

TERPS criteria were applied to the 

conditions existing or anticipated at the 

affected airports. Because of the close 

and immediate relationship between 

these SIAPs, Takeoff Minimums and 

ODPs, and safety in air commerce, I find 

that notice and public procedure under 

5 U.S.C. 553(b) are impracticable and 

contrary to the public interest and, 

where applicable, under 5 U.S.C. 553(d), 

good cause exists for making some 

SIAPs effective in less than 30 days. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. It, therefore—(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); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. For the same 

reason, the FAA certifies that this 

amendment will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 97 

Air traffic control, Airports, 

Incorporation by reference, Navigation 

(air). 

Issued in Washington, DC, on July 27, 

2018. 

Rick Domingo, 

Executive Director, Flight Standards Service. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me, Title 14, 

Code of Federal Regulations, Part 97 (14 

CFR part 97) is amended by 

establishing, amending, suspending, or 

removing Standard Instrument 

Approach Procedures and/or Takeoff 

Minimums and Obstacle Departure 

Procedures effective at 0901 UTC on the 

dates specified, as follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40106, 40113, 40114, 40120, 44502, 44514, 

44701, 44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

Effective 13 September 2018 

Ketchikan, AK, Ketchikan Intl, RNAV (GPS) 

RWY 29, Orig 

Ketchikan, AK, Ketchikan Intl, RNAV (GPS)- 

B, Amdt 1 

Geneva, AL, Geneva Muni, Takeoff 

Minimums and Obstacle DP, Amdt 1 

Fayetteville, AR, Drake Field, LDA RWY 34, 

Amdt 5 

Fayetteville, AR, Drake Field, VOR/DME–B, 

Orig-B, CANCELED 

Oakland, CA, Metropolitan Oakland Intl, 

RNAV (RNP) Z RWY 12, Amdt 2 

San Francisco, CA, San Francisco Intl, ILS 

OR LOC RWY 19L, Amdt 22 

San Francisco, CA, San Francisco Intl, RNAV 

(GPS) RWY 19R, Amdt 3 

Watsonville, CA, Watsonville Muni, Takeoff 

Minimums and Obstacle DP, Amdt 5A 

Watsonville, CA, Watsonville Muni, 

WATSONVILLE FOUR, Graphic DP 

Augusta, GA, Daniel Field, RNAV (GPS) 

RWY 5, Orig 

Cedartown, GA, Polk County Airport— 

Cornelius Moore Field, RNAV (GPS) RWY 

10, Orig-B 

Cedartown, GA, Polk County Airport— 

Cornelius Moore Field, RNAV (GPS) RWY 

28, Orig-B 

Paris, ID, Bear Lake County, RNAV (GPS) 

RWY 10, Orig 

Paris, ID, Bear Lake County, RNAV (GPS) 

RWY 28, Orig 

Paris, ID, Bear Lake County, Takeoff 

Minimums and Obstacle DP, Orig 

Bolingbrook, IL, Bolingbrook’s Clow Intl, 

RNAV (GPS)-B, Amdt 1A 

Bolingbrook, IL, Bolingbrook’s Clow Intl, 

VOR–A, Amdt 1A 

Springfield, IL, Abraham Lincoln Capital, ILS 

OR LOC RWY 22, Amdt 9C 

French Lick, IN, French Lick Muni, RNAV 

(GPS) RWY 8, Amdt 1C 

French Lick, IN, French Lick Muni, RNAV 

(GPS) RWY 26, Orig-C 

Indianapolis, IN, Indianapolis Rgnl, RNAV 

(GPS) RWY 34, Amdt 1B 

Topeka, KS, Topeka Rgnl, TACAN RWY 13, 

Amdt 4B 

New Roads, LA, False River Rgnl, LOC RWY 

36, Amdt 2 

New Roads, LA, False River Rgnl, NDB RWY 

36, Amdt 2A, CANCELED 

New Roads, LA, False River Rgnl, RNAV 

(GPS) RWY 18, Amdt 1 

New Roads, LA, False River Rgnl, RNAV 

(GPS) RWY 36, Amdt 1 

Boston, MA, General Edward Lawrence 

Logan Intl, RNAV (GPS) RWY 4R, Amdt 2B 

Detroit, MI, Detroit Metropolitan Wayne 

County, ILS OR LOC RWY 4R, ILS RWY 4R 

SA CAT I, ILS RWY 4R CAT II, ILS RWY 

4R CAT III, Amdt 19A 

Detroit, MI, Detroit Metropolitan Wayne 

County, ILS PRM RWY 4R (CLOSE 

PARALLEL), ILS PRM RWY 4R (CLOSE 

PARALLEL) SA CAT I, ILS PRM RWY 4R 

(CLOSE PARALLEL) CAT II, ILS PRM 

RWY 4R (CLOSE PARALLEL) CAT III, 

Amdt 3A 

Greenville, MI, Greenville Muni, Takeoff 

Minimums and Obstacle DP, Amdt 2B 

Marquette, MI, Sawyer Intl, ILS OR LOC 

RWY 1, Amdt 1 

Marquette, MI, Sawyer Intl, RNAV (GPS) 

RWY 1, Amdt 1 

Marquette, MI, Sawyer Intl, RNAV (GPS) 

RWY 19, Amdt 2 

Marquette, MI, Sawyer Intl, VOR RWY 19, 

Amdt 1 

Hinckley, MN, Field of Dreams, RNAV (GPS) 

RWY 24, Orig-A, CANCELED 

Red Wing, MN, Red Wing Rgnl, Takeoff 

Minimums and Obstacle DP, Amdt 2A 

Bismarck, ND, Bismarck Muni, ILS OR LOC 

RWY 31, Amdt 34A 


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Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40973 

Garrison, ND, Garrison Muni, RNAV (GPS) 

RWY 13, Amdt 2 

Garrison, ND, Garrison Muni, RNAV (GPS) 

RWY 31, Amdt 2 

Manchester, NH, Manchester, Takeoff 

Minimums and Obstacle DP, Amdt 10B 

Mesquite, NV, Mesquite, RNAV (GPS) Y 

RWY 2, Orig 

Mesquite, NV, Mesquite, RNAV (GPS) Z 

RWY 2, Orig 

Mesquite, NV, Mesquite, Takeoff Minimums 

and Obstacle DP, Orig 

Minden, NV, Minden-Tahoe, RNAV (GPS)-A, 

Amdt 1 

Minden, NV, Minden-Tahoe, RNAV (GPS)-B, 

Amdt 1 

Columbus, OH, Bolton Field, ILS OR LOC 

RWY 4, Amdt 5A 

Columbus, OH, Bolton Field, NDB RWY 4, 

Amdt 7A 

Columbus, OH, Bolton Field, RNAV (GPS) 

RWY 4, Orig-B 

Lebanon, OH, Warren County/John Lane 

Field, NDB–A, Amdt 6 

Idabel, OK, Mc Curtain County Rgnl, RNAV 

(GPS) RWY 2, Amdt 1 

Idabel, OK, Mc Curtain County Rgnl, RNAV 

(GPS) RWY 20, Amdt 1 

Corvallis, OR, Corvallis Muni, ILS OR LOC 

RWY 17, Amdt 5 

Corvallis, OR, Corvallis Muni, RNAV (GPS) 

RWY 35, Amdt 3 

Corvallis, OR, Corvallis Muni, VOR RWY 17, 

Amdt 8 

Corvallis, OR, Corvallis Muni, VOR RWY 35, 

Amdt 12 

Corvallis, OR, Corvallis Muni, VOR–A, Amdt 

11 

Borger, TX, Hutchinson County, RNAV (GPS) 

RWY 17, Amdt 1 

Borger, TX, Hutchinson County, RNAV (GPS) 

RWY 35, Amdt 1 

Dallas, TX, Dallas Love Field, ILS OR LOC 

RWY 31L, Amdt 22A 

Dallas, TX, Dallas Love Field, ILS OR LOC 

RWY 31R, ILS RWY 31R SA CAT I, ILS 

RWY 31R SA CAT II, Amdt 7 

Dallas, TX, Dallas Love Field, ILS Y OR LOC 

Y RWY 13L, Amdt 33A 

Dallas, TX, Dallas Love Field, ILS Y OR LOC 

Y RWY 13R, Amdt 6A 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Y RWY 13L, Amdt 1C 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Y RWY 13R, Orig-B 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Y RWY 31L, Amdt 1E 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Y RWY 31R, Amdt 3 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Z RWY 13L, Amdt 3B 

Dallas, TX, Dallas Love Field, RNAV (GPS) 

Z RWY 13R, Amdt 2A 

Dallas, TX, Dallas Love Field, RNAV (RNP) 

W RWY 13L, Orig-C 

Dallas, TX, Dallas Love Field, RNAV (RNP) 

X RWY 13L, Orig-C 

Houston, TX, West Houston, RNAV (GPS) 

RWY 15, Amdt 1C 

Houston, TX, West Houston, RNAV (GPS) 

RWY 33, Amdt 1B 

Houston, TX, West Houston, VOR–D, Amdt 

1, CANCELED 

La Grange, TX, Fayette Rgnl Air Center, 

Takeoff Minimums and Obstacle DP, 

Amdt 1 

Port Lavaca, TX, Calhoun County, Takeoff 

Minimums and Obstacle DP, Orig-A 

RESCINDED: On July 16, 2018 (83 FR 

32766), the FAA published an Amendment 

in Docket No. 31202, Amdt No. 3807, to Part 

97 of the Federal Aviation Regulations under 

section 97.25, 97.29, 97.33, and 97.37. The 

following entries for Asheville, NC, and 

Cleveland, TN, effective September 13, 2018, 

are hereby rescinded in their entirety: 

Asheville, NC, Asheville Rgnl, ILS OR LOC 

RWY 35, Orig 

Asheville, NC, Asheville Rgnl, ILS OR LOC 

RWY 35, Orig, CANCELED 

Asheville, NC, Asheville Rgnl, LOC RWY 17, 

Orig 

Asheville, NC, Asheville Rgnl, RNAV (GPS) 

RWY 17, Orig 

Asheville, NC, Asheville Rgnl, RNAV (GPS) 

RWY 17, Orig, CANCELED 

Asheville, NC, Asheville Rgnl, RNAV (GPS) 

RWY 35, Orig 

Asheville, NC, Asheville Rgnl, RNAV (GPS) 

RWY 35, Orig, CANCELED 

Asheville, NC, Asheville Rgnl, Takeoff 

Minimums and Obstacle DP, Amdt 1 

Cleveland, TN, Cleveland Rgnl Jetport, RNAV 

(GPS) RWY 3, Amdt 2 

Cleveland, TN, Cleveland Rgnl Jetport, RNAV 

(GPS) RWY 21, Amdt 2 

Cleveland, TN, Cleveland Rgnl Jetport, 

Takeoff Minimums and Obstacle DP, 

Amdt 2 

[FR Doc. 2018–17619 Filed 8–16–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2017–N–6730] 

Medical Devices and Device-Led 

Combination Products; Voluntary 

Malfunction Summary Reporting 

Program for Manufacturers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; order granting 

alternative. 

SUMMARY: The Food and Drug 

Administration’s (FDA, Agency, or we) 

Center for Devices and Radiological 

Health and Center for Biologics 

Evaluation and Research are 

announcing that the Agency is granting 

an alternative that permits manufacturer 

reporting of certain device malfunction 

medical device reports (MDRs) in 

summary form on a quarterly basis. We 

refer to this alternative as the 

‘‘Voluntary Malfunction Summary 

Reporting Program.’’ This voluntary 

program reflects goals for streamlining 

malfunction reporting outlined in the 

commitment letter agreed to by FDA 

and industry and submitted to Congress, 

as referenced in the Medical Device 

User Fee Amendments of 2017 (MDUFA 

IV Commitment Letter). 

DATES: This voluntary program applies 

only to reportable malfunction events 

that manufacturers become aware of on 

or after August 17, 2018. See further 

discussion in section IV.F. ‘‘Submission 

Schedule and Logistics.’’ 

FOR FURTHER INFORMATION CONTACT: 

Michelle Rios, Center for Devices and 

Radiological Health (CDRH), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3222, 

Silver Spring, MD 20993, 301–796– 

6107, MDRPolicy@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911; or CBER, Office of 

Communication, Outreach, and 

Development (OCOD), 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002; or by 

calling 1–800–835–4709 or 240–402– 

8010; or email: ocod@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Every year, FDA receives hundreds of 

thousands of MDRs of suspected deviceassociated deaths, serious injuries, and 

malfunctions. The Agency’s MDR 

program is one of the postmarket 

surveillance tools FDA uses to monitor 

device performance, detect potential 

device-related safety issues, and 

contribute to benefit-risk assessments. 

Malfunction reports represent a 

substantial fraction of the MDRs FDA 

receives on an annual basis. 

Medical device reporting 

requirements for manufacturers are set 

forth in section 519 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360i) and the regulations 

contained in part 803 (21 CFR part 803). 

Among other things, part 803 requires 

the submission of an individual MDR 

when a manufacturer becomes aware of 

information, from any source, which 

reasonably suggests that one of its 

marketed devices malfunctioned and 

the malfunction of the device or a 

similar device marketed by the 

manufacturer would be likely to cause 

or contribute to a death or serious injury 

if the malfunction were to recur 

(§§ 803.10(c)(1) and 803.50(a)(2). 

Throughout this document, we refer to 

such malfunctions as ‘‘reportable 

malfunctions’’ or ‘‘reportable 

malfunction events.’’ 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 


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