Understanding the FDA Device Approval Process in FPMRS

Current Bladder Dysfunction Reports ◽

10.1007/s11884-021-00630-7 ◽

2021 ◽

Author(s):

Nathan Cheng ◽

Debra Fromer

Keyword(s):

Approval Process ◽

Device Approval

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Changes Underway in Device Approval Process

Laboratory Medicine ◽

10.1093/labmed/26.9.562 ◽

1995 ◽

Vol 26 (9) ◽

pp. 562-563

Author(s):

Jennifer Thomas

Keyword(s):

Approval Process ◽

Device Approval

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TU-AB-204-01: Device Approval Process

Medical Physics ◽

10.1118/1.4957387 ◽

2016 ◽

Vol 43 (6Part32) ◽

pp. 3729-3729

Author(s):

J. Delfino

Keyword(s):

Approval Process ◽

Device Approval

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Orthopaedic Device Approval Through the Premarket Approval Process

The Journal of Bone and Joint Surgery (American) ◽

10.2106/jbjs.16.00050 ◽

2017 ◽

Vol 99 (6) ◽

pp. e26 ◽

Author(s):

Brian W. Yang ◽

Matthew L. Iorio ◽

Charles S. Day

Keyword(s):

Approval Process ◽

Device Approval ◽

Premarket Approval ◽

Orthopaedic Device

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Expedited Device Approval Process Has Fans, Foes

Journal of Clinical Engineering ◽

10.1097/jce.0b013e3182049c40 ◽

2011 ◽

Vol 36 (1) ◽

pp. 11-12

Author(s):

&NA;

Keyword(s):

Approval Process ◽

Device Approval

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New Studies Fault Device Approval Process

Biomedical Safety & Standards ◽

10.1097/01.bmsas.0000367671.66326.1f ◽

2010 ◽

Vol 40 (3) ◽

pp. 24

Keyword(s):

Approval Process ◽

Device Approval

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FDA Admits Device Approval Process Is Deeply Flawed

Biomedical Safety & Standards ◽

10.1097/01.bmsas.0000363984.36264.29 ◽

2009 ◽

Vol 39 (21) ◽

pp. 168

Keyword(s):

Approval Process ◽

Device Approval

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MEDICAL DEVICE APPROVAL PROCESS IN JAPAN

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v1i2.45 ◽

2011 ◽

Vol 1 (2) ◽

Author(s):

Devesh Sharma

Keyword(s):

Medical Device ◽

Approval Process ◽

Device Approval

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The Federal Biologics/Drug/Device Approval Process

Academia to Biotechnology ◽

10.1016/b978-012284151-4/50008-7 ◽

2005 ◽

pp. 39-44

Author(s):

Jeffrey M. Gimble

Keyword(s):

Approval Process ◽

Device Approval

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IOM Report: Device Approval Process Needs to Be Replaced

Skin & Allergy News ◽

10.1016/s0037-6337(11)70457-0 ◽

2011 ◽

Vol 42 (9) ◽

pp. 10

Author(s):

MARY ELLEN SCHNEIDER

Keyword(s):

Approval Process ◽

Device Approval

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The Device Approval Process

Point-of-Care Testing ◽

10.1201/b14092-3 ◽

2002 ◽

pp. 31-57

Author(s):

Erika Ammirati

Keyword(s):

Approval Process ◽

Device Approval

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