Defending Substantial Equivalence: An Argument for the Continuing Validity of the 510(k) Premarket Notification Process

被引:0
|
作者
Flaherty, James M., Jr. [1 ]
机构
[1] Foley Hoag LLP, Boston, MA USA
关键词
D O I
暂无
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
引用
收藏
页码:901 / 927
页数:27
相关论文
共 6 条
  • [1] Matritech submits 510(k) premarket notification for colorectal cancer test
    不详
    BIOTECHNOLOGY LAW REPORT, 1997, 16 (5-6): : 558 - 558
  • [2] Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices
    Redberg, Rita F.
    Dhruva, Sanket S.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2019, 322 (10): : 927 - 928
  • [3] Clarification: 510k is premarket notification; it provides no patent or FDA approval
    Burkhart, Craig G.
    Burkhart, Craig N.
    JOURNAL OF DRUGS IN DERMATOLOGY, 2008, 7 (02) : 105 - 105
  • [4] Fda's Current Approach To Premarket Notification SuBMIssions (510(k)s) For Continuous Positive Pressure Ventilators
    Glindmeyer, H. W.
    Harry, A.
    AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2014, 189
  • [5] Bearing the Burden of "Innovation" The Ontological Implications of Substantial Equivalence and the FDA 510(K) Pathway
    Maldonado, Fabien
    Eberl, Jason
    CHEST, 2023, 163 (05) : 1225 - 1227
  • [6] Premarket Approval Through the 510(k) Process: Lessons from the Translation Process of Magnetic Resonance Elastography
    Ortiz, Jaime A. Aponte
    Konik, Ewa
    Eckert, Elizabeth C.
    Pepin, Kay M.
    Greenberg-Worisek, Alexandra
    CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2018, 11 (05): : 447 - 449