Laboratory Developed Test

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Laboratory Developed Test (LDT) is a term used to refer to a certain class of in vitro diagnostics (IVDs) that, in the US, were traditionally regulated under the Clinical Laboratory Improvement Amendments program.[1]

United States[edit]

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.[2][3]

As LDTs do not require FDA 510(k) clearance required by other diagnostic tests, they have been viewed as a regulatory loophole by opponents.[4][5]

References[edit]

  1. ^ "CLIA Overview". CMS. 11 April 2018. 
  2. ^ FDA. "F.D.A. Acts on Lab Tests Developed In-House". 
  3. ^ "Laboratory Developed Tests". FDA. 26 March 2018. 
  4. ^ 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. 
  5. ^ 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.