Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests
نویسندگان
چکیده
منابع مشابه
FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?
In 2010 the US Food and Drug Administration (FDA) stated that it would issue guidance on its oversight of laboratory-developed tests (LDTs), and in July of that year the FDA held a public meeting to receive feedback on a risk-based application of LDT oversight (http:// www.fda.gov/MedicalDevices/NewsEvents/Workshops Conferences/ucm212830.htm). The FDA acknowledged that LDTs have been in existen...
متن کاملRegulating laboratory-developed tests.
Disclaimer: The views expressed in this editorial are solely those of the author and should not be construed as reflecting the views of the Department of Veterans Affairs or the United States Government. As a molecular pathologist for more than 20 years, I have had the opportunity to develop laboratory tests and to assess the efforts of others to develop laboratory tests. As Editor of The Journ...
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D iagnostic tests are essential for accelerating health solutions. The discovery of significant variants and the availability of reliable diagnostic tests afford patients and clinicians a range of benefits from an end to the diagnostic odyssey to better treatment options and improved health. Test developers believe that obtaining approval from the Food and Drug Administration (FDA) for diagnost...
متن کاملPoint-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.
Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use an...
متن کاملThe long and winding regulatory road for laboratory-developed tests.
"High complexity" clinical laboratories are approved under the Clinical Laboratory Improvement Amendments to develop, validate, and offer a laboratory-developed test (LDT) for clinical use. The Food and Drug Administration considers LDTs to be medical devices under their regulatory jurisdiction, and that at least certain LDTs should be subject to greater regulatory scrutiny. This review describ...
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ژورنال
عنوان ژورنال: The Journal of Molecular Diagnostics
سال: 2014
ISSN: 1525-1578
DOI: 10.1016/j.jmoldx.2013.10.003