Concepedia

Premarket Evidence Development

Premarket Evidence Development is a systematic process within regulatory science that generates empirical data and analytical justifications to demonstrate the safety, efficacy, and performance of a medical device prior to market authorization, distinguishing it from postmarket surveillance by focusing on pre-commercialization validation requirements under frameworks such as Investigational Device Exemptions.

10

Publications

256

Citations

43

Authors

30

Institutions

Publications per year

2017–2026

7

Parents

Publications

10

Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

Jeremy Puthumana, Joshua D. Wallach, Joseph S. Ross · JAMA · 2018 · 59 citations · Full text

, , +16

PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

Frank Hulstaert, Mattias Neyt, Imgard Vinck et al. · International Journal of Technology Assessment in Health Care · 2012 · 49 citations · Full text

, , +16

Learning from Our Mistakes? Testing New ICD Technology

Robert G. Hauser, Adrian K. Almquist · New England Journal of Medicine · 2008 · 34 citations

, , +17

An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations

Rosanna Tarricone, Helen Banks, Oriana Ciani et al. · Expert Review of Medical Devices · 2023 · 23 citations · Full text

, , +17

Physicians’ Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey

Sanket S. Dhruva, Aaron S. Kesselheim, Steven Woloshin et al. · Health Affairs · 2024 · 23 citations

, , +15

1–5 of 10

Authors

43

  1. RF
    Rita F. Redberg

    University of California, San Francisco, United States

    2 publications · 33 citations

    2

    h-index

  2. SS
    Sanket S. Dhruva

    University of California, San Francisco, United States

    2 publications · 33 citations

    2

    h-index

  3. JS
    Joseph S. Ross

    Yale University, United States

    1 publications · 59 citations

    1

    h-index

  4. JD
    Joshua D. Wallach

    Yale University, United States

    1 publications · 59 citations

    1

    h-index

  5. MP
    Mira Pavlovic

    University of Ferrara, Italy

    1 publications · 49 citations

    1

    h-index

1–5 of 43

Institutions

30

  1. Yale University

    New Haven, United States

    2 h-index

    4 publications

    187 citations

  2. Bocconi University

    Milan, Italy

    1 h-index

    3 publications

    69 citations

  3. Assistance Publique – Hôpitaux de Paris

    Paris, France

    1 h-index

    1 publications

    23 citations

  4. University of Redlands

    Redlands, United States

    1 h-index

    1 publications

    23 citations

  5. Hôpital Européen

    Marseille, France

    1 h-index

    1 publications

    23 citations

  6. University of California, San Francisco

    San Francisco, United States

    1 h-index

    2 publications

    20 citations

  7. Erasmus University Rotterdam

    Rotterdam, The Netherlands

    1 h-index

    1 publications

    23 citations

  8. Hôpital Européen Georges-Pompidou

    Paris, France

    1 h-index

    1 publications

    23 citations

1–8 of 30

Venues

  1. 2

    h-index

  2. JAMA Health Forum

    1 publications · 11 citations

    1

    h-index

  3. New England Journal of Medicine

    NEJM · 1 publications · 34 citations

    1

    h-index

  4. Expert Review of Medical Devices

    1 publications · 23 citations

    1

    h-index

  5. JAMA

    1 publications · 59 citations

    1

    h-index

1–5