Laboratory-Developed Tests: A Legislative and Regulatory Review
نویسندگان
چکیده
منابع مشابه
The 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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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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For 2 days in January, the National Institutes of Health was the epicenter of the debate that has swirled around laboratory-developed tests (LDTs) since last July, when the U.S. Food and Drug Administration announced it would begin regulating them. More than 80 people—representing pathologists , clinicians, patients, and laborato-ries—spoke during FDA's unusually large and long public workshop....
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ژورنال
عنوان ژورنال: Clinical Chemistry
سال: 2017
ISSN: 0009-9147,1530-8561
DOI: 10.1373/clinchem.2017.275164