Laboratory-Developed Tests in the New European Union 2017/746 Regulation: Opportunities and Risks

被引：13
|
作者：
Vogeser, Michael [1 ]
Brueggemann, Monika [2 ]
Lennerz, Jochen [3 ]
Stenzinger, Albrecht [4 ]
Gassner, Ulrich M. [5 ]
机构：
[1] Ludwig Maximilians Univ Munchen, Inst Lab Med, Univ Hosp, Marchioninistr 15, DE-81377 Munich, Germany
[2] Univ Hosp Schleswig Holstein, Dept Hematol, Kiel, Germany
[3] Massachusetts Gen Hosp, Harvard Med Sch, Ctr Integrated Diagnost, Boston, MA 02114 USA
[4] Univ Hosp Heidelberg, Inst Pathol, Heidelberg, Germany
[5] Univ Augsburg, Fac Law, Inst Med Device Law, Augsburg, Germany
来源：
CLINICAL CHEMISTRY | 2022年 / 68卷 / 01期
关键词：
FDA;
D O I：
10.1093/clinchem/hvab215
中图分类号：
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号：
1001 ;
摘要：
[No abstract available]
引用
收藏
页码：40 / 42
页数：3
相关论文
共 50 条
  • [41] Laboratory-Developed Tests Account for a Small Minority of Tests Ordered in an Academic Hospital System
    Rychert, Jenna
    Schmidt, Robert L.
    Genzen, Jonathan R.
    AMERICAN JOURNAL OF CLINICAL PATHOLOGY, 2023, 160 (03) : 297 - 302
  • [42] Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests A Position Statement of the Association for Molecular Pathology
    Ferreira-Gonzalez, Andrea
    Emmadi, Rajyasree
    Day, Stephen P.
    Klees, Robert F.
    Leib, Jennifer R.
    Lyon, Elaine
    Nowak, Jan A.
    Pratt, Victoria M.
    Williams, Mary S.
    Klein, Roger D.
    JOURNAL OF MOLECULAR DIAGNOSTICS, 2014, 16 (01): : 3 - 6
  • [43] The US FDA's proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing
    Smith, Leslie
    Carricaburu, Lisa A.
    Genzen, Jonathan R.
    PRACTICAL LABORATORY MEDICINE, 2024, 40
  • [44] The FDA's proposed rule on laboratory-developed tests: what happens next?
    Genzen, Jonathan R.
    Moser, Karen A.
    LABORATORY MEDICINE, 2024, 55 (02) : 109 - 110
  • [45] Regulatory oversight for research tests and laboratory-developed diagnostics should be more nimble
    Berry, Donna M.
    Parekh, Rulan S.
    Irwin, Meredith S.
    CANADIAN MEDICAL ASSOCIATION JOURNAL, 2019, 191 (50) : E1388 - E1388
  • [46] Modernizing Federal Oversight of Laboratory-Developed Tests - Toward Safety, Validity, and Utility
    Singhal, Udit
    Horrow, Caroline
    Kesselheim, Aaron S.
    Morgan, Todd M.
    NEW ENGLAND JOURNAL OF MEDICINE, 2023, 389 (19): : 1735 - 1737
  • [47] Strengthen federal regulation of laboratory-developed and direct-to-consumer genetic testing
    Starkweather, Angela R.
    Coleman, Bernice
    de Mendoza, Veronica Barcelona
    Fu, Mei R.
    Menzies, Victoria
    O'Keefe, Mary
    Williams, Janet K.
    NURSING OUTLOOK, 2018, 66 (01) : 101 - 104
  • [48] Introducing New Laboratory-Developed Molecular Methods in the Clinical Microbiology Laboratories
    Pouladfar, Gholamreza
    IRANIAN JOURNAL OF MEDICAL SCIENCES, 2012, 37 (03) : 200 - 201
  • [49] European Union Regulation of Water Stress Risks
    Stupazzini, Riccardo
    EUROPEAN JOURNAL OF RISK REGULATION, 2024, 15 (01) : 102 - 121
  • [50] FDA Oversight of Laboratory-Developed Tests: Is It Necessary, and How Would It Impact Clinical Laboratories?
    Scott, Mitchell G.
    Ashwood, Edward R.
    Annesley, Thomas M.
    Leonard, Debra G. B.
    Burgess, Michael C.
    CLINICAL CHEMISTRY, 2013, 59 (07) : 1017 - 1022
12345