Literature DB >> 19601388

Defending substantial equivalence: an argument for the continuing validity of the 510(k) premarket notification process.

James M Flaherty1.   

Abstract

Mesh：

Year:  2008        PMID： 19601388

Source DB:  PubMed          Journal:  Food Drug Law J        ISSN： 1064-590X            Impact factor:   0.619


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  7 in total

1.  Characterizing the Utility and Limitations of Repurposing an Open-Field Optical Imaging Device for Fluorescence-Guided Surgery in Head and Neck Cancer Patients.

Authors:  Lindsay S Moore; Eben L Rosenthal; Thomas K Chung; Esther de Boer; Neel Patel; Andrew C Prince; Melissa L Korb; Erika M Walsh; E Scott Young; Todd M Stevens; Kirk P Withrow; Anthony B Morlandt; Joshua S Richman; William R Carroll; Kurt R Zinn; Jason M Warram
Journal:  J Nucl Med       Date:  2016-09-01       Impact factor: 10.057

2.  Use of Mechanical Circulatory Support in Percutaneous Coronary Intervention in the United States.

Authors:  Rohan Khera; Peter Cram; Mary Vaughan-Sarrazin; Phillip A Horwitz; Saket Girotra
Journal:  Am J Cardiol       Date:  2015-10-23       Impact factor: 2.778

3.  Continuous Ketone Monitoring: A New Paradigm for Physiologic Monitoring.

Authors:  Jennifer Y Zhang; Trisha Shang; Suneil K Koliwad; David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2021-04-09

4.  Deep Learning Algorithm for Automated Cardiac Murmur Detection via a Digital Stethoscope Platform.

Authors:  John S Chorba; Avi M Shapiro; Le Le; John Maidens; John Prince; Steve Pham; Mia M Kanzawa; Daniel N Barbosa; Caroline Currie; Catherine Brooks; Brent E White; Anna Huskin; Jason Paek; Jack Geocaris; Dinatu Elnathan; Ria Ronquillo; Roy Kim; Zenith H Alam; Vaikom S Mahadevan; Sophie G Fuller; Grant W Stalker; Sara A Bravo; Dina Jean; John J Lee; Medeona Gjergjindreaj; Christos G Mihos; Steven T Forman; Subramaniam Venkatraman; Patrick M McCarthy; James D Thomas
Journal:  J Am Heart Assoc       Date:  2021-04-26       Impact factor: 5.501

Review 5.  Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association.

Authors:  Kimberly Levenhagen; Claire Davies; Marisa Perdomo; Kathryn Ryans; Laura Gilchrist
Journal:  Phys Ther       Date:  2017-07-01

Review 6.  Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.

Authors:  Carl J Heneghan; Ben Goldacre; Igho Onakpoya; Jeffrey K Aronson; Tom Jefferson; Annette Pluddemann; Kamal R Mahtani
Journal:  BMJ Open       Date:  2017-12-06       Impact factor: 2.692

Review 7.  Roadside Drug Testing Approaches.

Authors:  Manal A Alhefeiti; James Barker; Iltaf Shah
Journal:  Molecules       Date:  2021-05-29       Impact factor: 4.411
  7 in total

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