FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests. This use of “enforcement discretion” has been under review by the Agency for many years, and particularly since the Agency hosted a 2010 public meeting on this topic. This presentation will provide a general overview of IVD regulation and a discussion of the current regulatory situation for laboratory developed tests. The presentation will further discuss FDA’s draft policy guidance for enforcement of applicable regulatory requirements for Laboratory Developed Tests which was published in October of 2014, will provide an overview of the feedback that was received from Stakeholders on this document and will discuss next steps in the guidance finalization process.
Research And Development
Clinical Laboratory Scientist50%
Medical Laboratory Technician50%
Manufacturer - Other50%