In 2010 the US Food and Drug Administration (FDA)7 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/WorkshopsConferences/ucm212830.htm). The FDA acknowledged that LDTs have been in existence since the Medical Device Amendments of 1976 and that historically they had exercised enforcement discretion with respect to oversight. In 2010, however, the FDA stated that the complexity and risk associated with newer LDTs were such that oversight was necessary and that the FDA has “the statutory authority to assure that devices, including LDTs, are safe and effective for their intended use.”
In the current issue of Clinical Chemistry, experts discussed this issue in this Q&A (free to access). We’d like to hear what you have to say about this topic.
A modification of an existing FDA-approved assay makes the assay an LDT at that particular institution. An example would be to use cerebrospinal fluid when the manufacturer does not include that sample type in its instructions for use. Should this type of LDT also be reviewed and approved by the FDA?
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