Laboratory developed test
Laboratory Developed Test (LDT) is a term used to refer to a certain class of in vitro diagnostics (IVDs).
United States
In the United States, the Food and Drug Administration (FDA) has determined that while such tests qualify as medical devices, FDA will allow these products to enter the market without prior approval from the Agency. On July 31, 2014, the FDA announced that it will start regulating some LDTs.[1]
As LDTs do not require FDA 510k clearance required by other diagnostic tests, they have been viewed as a regulatory loophole by opponents.[2][3]
References
- ^ FDA. "F.D.A. Acts on Lab Tests Developed In-House".
- ^ Jotwani, Rohan; Boumil, Marcia; Salem, Deeb; Wetterhahn, Madeline; Beninger, Paul (September 2017). "Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion". Clinical Pharmacology in Drug Development. 6 (5): 433–438. doi:10.1002/cpdd.374.
{{cite journal}}:|access-date=requires|url=(help) - ^ Duhaime-Ross, Arielle (Nov 17, 2015). "FDA wants to close the loophole that Theranos used, but Republicans don't understand why". The Verge. Retrieved 5 April 2018.
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