The need for increased US FDA oversight of laboratory-developed and other laboratory tests - April 2017

April 7, 2017

The US Food and Drug Administration (FDA) still plans to increase oversight of laboratory-developed tests (LDTs), despite an announcement in November 2016 that it will delay work until the new Administration is in place. One of the Agency’s first steps was the drafting of a guidance document: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). The purpose of this article is to examine the position of the FDA as set out in the draft guidance, taking note of the discussion paper released in January 2017, and propose how the FDA could move forward with minimal impact on medical laboratories while accomplishing the accountability and transparency the public deserves.

 

Click here for the full article from Global Regulatory Press.

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