Literature DB >> 30228612

FDA Device Regulation.

Madelyn Lauer1, Jordan P Barker2, Mitchell Solano3, Jonathan Dubin4.   

Abstract

Mesh：

Year:  2017        PMID： 30228612      PMCID： PMC6140070     

Source DB:  PubMed          Journal:  Mo Med        ISSN： 0026-6620


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  10 in total

Review 1.  Medical device regulation: an introduction for the practicing physician.

Authors:  William H Maisel
Journal:  Ann Intern Med       Date:  2004-02-17       Impact factor: 25.391

Review 2.  The evidence-based approach in bringing new orthopaedic devices to market.

Authors:  Emil H Schemitsch; Mohit Bhandari; Scott D Boden; Robert B Bourne; Kevin J Bozic; Joshua J Jacobs; Rad Zdero
Journal:  J Bone Joint Surg Am       Date:  2010-04       Impact factor: 5.284

3.  AAOS clinical practice guideline: treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition.

Authors:  Greg A Brown
Journal:  J Am Acad Orthop Surg       Date:  2013-09       Impact factor: 3.020

Review 4.  Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.

Authors:  Sanket S Dhruva; Lisa A Bero; Rita F Redberg
Journal:  JAMA       Date:  2009-12-23       Impact factor: 56.272

5.  Medical devices--balancing regulation and innovation.

Authors:  Gregory D Curfman; Rita F Redberg
Journal:  N Engl J Med       Date:  2011-08-10       Impact factor: 91.245

6.  Primer on medical device regulation. Part III. Regulatory mechanisms and import/export regulation.

Authors:  L H Monsein
Journal:  Radiology       Date:  1997-10       Impact factor: 11.105

7.  Recent Trends in Orthopedic Device Regulation.

Authors:  Jordan P Barker; Jonathan Dubin
Journal:  Orthopedics       Date:  2015-07-01       Impact factor: 1.390

8.  The 510(k) ancestry of a metal-on-metal hip implant.

Authors:  Brent M Ardaugh; Stephen E Graves; Rita F Redberg
Journal:  N Engl J Med       Date:  2013-01-10       Impact factor: 91.245

Review 9.  How a fake hip showed up failings in European device regulation.

Authors:  Deborah Cohen
Journal:  BMJ       Date:  2012-10-24

10.  Medical Device Regulation: A Comparison of the United States and the European Union.

Authors:  Travis G Maak; James D Wylie
Journal:  J Am Acad Orthop Surg       Date:  2016-08       Impact factor: 3.020
  10 in total
  2 in total

1.  Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

Authors:  Jonathan R Dubin; Stephen D Simon; Kirsten Norrell; Jacob Perera; Jacob Gowen; Akin Cil
Journal:  JAMA Netw Open       Date:  2021-05-03

Review 2.  Advances in spray products for skin regeneration.

Authors:  Paula Pleguezuelos-Beltrán; Patricia Gálvez-Martín; Daniel Nieto-García; Juan Antonio Marchal; Elena López-Ruiz
Journal:  Bioact Mater       Date:  2022-03-08
  2 in total

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