The long and winding regulatory road for laboratory-developed tests.
Abstract
"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 describes the current regulatory framework for LDTs and suggests ways in which to appropriately enhance this framework.
我要评论
本期排行
- The pathwork tissue of origin ...
- Retraction. LMX1A as a prognos...
- Developmental differences in m...
- Thymic carcinoma, part 1: a cl...
- Pathology consultation on myel...
- The who and when of molecular ...
- The long and winding regulator...
- Immunohistochemistry cocktails...
- Diagnostic value of EAAT-1 and...
- No evidence for interference o...
共0条评论