Requirements to bring a medical device to market

被引：0
作者：
Buenz, Eric J. [1 ,2 ,3 ]
Wallace, Victoria M. [4 ]
Friedman, Suzanne Levy [4 ]
机构：
[1] Mayo Clin, Rochester, MN 55905 USA
[2] Device Navigator, Motueka, New Zealand
[3] Nelson Marlborough Inst Technol, Nelson, New Zealand
[4] Hogan Lovells US LLP, Washington, DC USA
来源：
TRENDS IN BIOTECHNOLOGY | 2025年 / 43卷 / 01期
关键词：
PREMARKET APPROVAL; FDA;
D O I：
10.1016/j.tibtech.2024.07.016
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
引用
收藏
页码：4 / 7
页数：4
相关论文
共 50 条
  • [21] Overview of the US FDA Medical Device Approval Process
    Ashwani Sastry
    [J]. Current Cardiology Reports, 2014, 16
  • [22] Getting your medical device cleared for marketing in the US
    Bartoo, G
    Munzner, RF
    [J]. PROCEEDINGS OF THE 26TH ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY, VOLS 1-7, 2004, 26 : 5136 - 5136
  • [23] Lack of Support in Medical Device Regulation within Academia
    Hendricusdottir, Rita
    Hussain, Azad
    Milnthorpe, William
    Bergmann, Jeroen H. M.
    [J]. PROSTHESIS, 2021, 3 (01):
  • [24] Overview of High-Risk Medical Device Innovation in Gastroenterology from 2000 to 2014: Enhancing the Pipeline
    Saleem, Nasir
    Xu, Shuai
    [J]. DIGESTIVE DISEASES AND SCIENCES, 2016, 61 (08) : 2165 - 2174
  • [25] Medical device regulation: what a practicing dermatologist should know
    Dang, Jiyoung M.
    Krause, David
    Felten, Richard P.
    Luke, Markham K.
    [J]. DERMATOLOGIC THERAPY, 2009, 22 (03) : 241 - 245
  • [26] ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products
    O'Neill, Tyler
    Miksad, Rebecca
    Miller, Danelle
    Maloney, Lesley
    John, Ani
    Hiller, Carolyn
    Hornberger, John
    [J]. VALUE IN HEALTH, 2019, 22 (07) : 754 - 761
  • [27] What is involved in a regulatory trial investigating a new medical device?
    McKay, Paula J.
    Resendes, Sarah
    Schemitsch, Emil
    Bhandari, Mohit
    [J]. Journal of Long-Term Effects of Medical Implants, 2007, 17 (02) : 165 - 171
  • [28] AN ANALYSIS OF CRITICAL FACTORS IN MEDICAL DEVICE DEVELOPMENT TO DESIGN FOR FDA
    Medina, Lourdes A.
    Kremer, Guel E. Okudan
    Wysk, Richard A.
    [J]. PROCEEDINGS OF THE ASME INTERNATIONAL DESIGN ENGINEERING TECHNICAL CONFERENCES AND COMPUTERS AND INFORMATION IN ENGINEERING CONFERENCE, VOL 5, 2012, : 591 - +
  • [29] Medical Device Recalls in Orthopedics: Recent Trends and Areas for Improvement
    Vajapey, Sravya P.
    Li, Mengnai
    [J]. JOURNAL OF ARTHROPLASTY, 2020, 35 (08) : 2259 - 2266
  • [30] An Overview of Global Professional Publications Related to Medical Device Cybersecurity
    Lechner, Nadica Hrgarek
    [J]. CENTRAL EUROPEAN CONFERENCE ON INFORMATION AND INTELLIGENT SYSTEMS (CECIIS 2020), 2020, : 219 - 230
12345