ASHI has prepared an official response to the FDA's new regulations for Laboratory Developed Tests. Please take the time to read ASHI's response and submit your own comments here. The draft guidance document is entitled "Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)".
The deadline to submit comments is Monday, February 2nd.
The FDA invites you to join a teleconference to discuss their proposed framework for oversight of Laboratory Developed Tests (LDTs).
This teleconference is part of the FDA's intention to obtain feedback in relation to its plans to issue new Regulations for Laboratory Developed Tests. These tests include those related to transplantation and non-transplant related tests such as for assessment of risk for disease and for drug hypersensitivity reactions.
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