Concepedia

Premarket Approval Classification

Premarket Approval Classification is a regulatory designation within medical device classification that identifies high-risk devices requiring rigorous scientific review and approval by a governmental authority prior to market release to ensure safety and effectiveness.

6

Publications

269

Citations

21

Authors

11

Institutions

Publications per year

2017–2026

2

Parents

Publications

6

Regulation of Probiotic Substances as Ingredients in Foods: Premarket Approval or “Generally Recognized as Safe” Notification

Antonia Mattia, Robert I. Merker · Clinical Infectious Diseases · 2008 · 87 citations

, , +17

Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan

Kazuo Yano, Natsumi Watanabe, Kenichiro Tsuyuki et al. · Regenerative Therapy · 2014 · 62 citations · Full text

, , +15

Cybersecurity features of digital medical devices: an analysis of FDA product summaries

Ariel Dora Stern, William J. Gordon, Adam Landman et al. · BMJ Open · 2019 · 50 citations · Full text

, , +17

Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications

Samuel Lee, Lauren Cho, Eyal Klang et al. · JAMA Network Open · 2021 · 26 citations · Full text

, , +12

U.S. Food and Drug Administration and regulation of medical devices in radiology.

William F. Pritchard, R F Carey · Radiology · 1997 · 23 citations

, , +17

1–5 of 6

Authors

21

  1. WF
    William F. Pritchard

    National Institutes of Health Clinical Center, United States

    1 publications · 23 citations

    1

    h-index

  2. TI
    Taisuke Ikawa

    Waseda University, Japan

    1 publications · 62 citations

    1

    h-index

  3. BS
    Benjamin S. Glicksberg

    Icahn School of Medicine at Mount Sinai, United States

    1 publications · 26 citations

    1

    h-index

  4. LC
    Lauren Cho

    Icahn School of Medicine at Mount Sinai, United States

    1 publications · 26 citations

    1

    h-index

  5. RB
    Robert B. Greenberg

    American Society of Health-System Pharmacists, United States

    1 publications · 21 citations

    1

    h-index

1–5 of 21

Institutions

11

  1. United States Food and Drug Administration

    Silver Spring, United States

    2 h-index

    2 publications

    110 citations

  2. Waseda University

    Tokyo, Japan

    1 h-index

    6 publications

    372 citations

  3. American Society of Health-System Pharmacists

    Bethesda, United States

    1 h-index

    1 publications

    21 citations

  4. Beth Israel Deaconess Medical Center

    Boston, United States

    1 h-index

    1 publications

    50 citations

  5. Tokyo Women's Medical University

    Tokyo, Japan

    1 h-index

    6 publications

    372 citations

  6. Icahn School of Medicine at Mount Sinai

    New York, United States

    1 h-index

    4 publications

    104 citations

  7. Deaconess Hospital

    Cincinnati, United States

    1 h-index

    1 publications

    50 citations

  8. Center for Food Safety and Applied Nutrition

    College Park, United States

    1 h-index

    2 publications

    174 citations

1–8 of 11

Venues

  1. JAMA Network Open

    1 publications · 26 citations

    1

    h-index

  2. Regenerative Therapy

    1 publications · 62 citations

    1

    h-index

  3. Clinical Infectious Diseases

    CID · 1 publications · 87 citations

    1

    h-index

  4. BMJ Open

    1 publications · 50 citations

    1

    h-index

  5. Radiology

    1 publications · 23 citations

    1

    h-index

1–5