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
  • [31] Counterpoint: Why the FDA Should Not Regulate Laboratory-Developed Tests
    Leung, Marco L.
    JOURNAL OF APPLIED LABORATORY MEDICINE, 2024, 9 (01): : 155 - 158
  • [32] FDA Oversight of Laboratory-Developed Tests Where Are We Now?
    Gatter, Ken
    ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE, 2017, 141 (06) : 746 - 748
  • [33] College of American Pathologists Proposal for the Oversight of Laboratory-Developed Tests
    Vance, Gail H.
    ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE, 2011, 135 (11) : 1432 - 1435
  • [34] Response to the Proposed Food and Drug Administration Regulation of Laboratory-Developed Tests: It Is Past Time for Professional Consensus
    Konnick, Eric Q.
    JOURNAL OF APPLIED LABORATORY MEDICINE, 2016, 1 (02): : 239 - 241
  • [35] Laboratory-developed test regulation and the immunocompromised patient: uncertainty ahead
    Clark, Andrew E.
    Levy, Jaclyn
    Lee, Francesca M.
    CURRENT OPINION IN INFECTIOUS DISEASES, 2020, 33 (04) : 304 - 311
  • [36] Integrity of SARS-CoV-2 Laboratory-Developed Tests Reply
    Adashi, Eli Y.
    Cohen, Glenn
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2022, 328 (05): : 478 - +
  • [37] Laboratory-developed tests and in vitro diagnostics: A regulatory overview for anatomic pathology
    Genzen, Jonathan R.
    Miller, Lauren J.
    Rets, Anton, V
    Affolter, Kajsa E.
    AMERICAN JOURNAL OF CLINICAL PATHOLOGY, 2025,
  • [38] Precision medicine and the FDA's draft guidance on laboratory-developed tests
    Hwang, Thomas J.
    Lehmann, Lisa Soleymani
    Kesselheim, Aaron S.
    NATURE BIOTECHNOLOGY, 2015, 33 (05) : 449 - 451
  • [39] Precision medicine and the FDA's draft guidance on laboratory-developed tests
    Thomas J Hwang
    Lisa Soleymani Lehmann
    Aaron S Kesselheim
    Nature Biotechnology, 2015, 33 : 449 - 451
  • [40] SARS-CoV-2 Laboratory-Developed Tests Integrity Restored
    Adashi, Eli Y.
    Cohen, I. Glenn
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2022, 327 (13): : 1229 - 1230
12345