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AMA News Room

Aug. 1, 2014

AMA Statement on FDA Proposal Regarding Diagnostic Testing

For immediate release:
Aug. 1, 2014

Statement attributed to:
Barbara L. McAneny, MD
Chair of the Board, American Medical Association

"The American Medical Association (AMA) believes that laboratory developed testing (LDT) services offer patients access to safe and high quality diagnostic services that are essential to patient care.

"The draft FDA Framework for Oversight of Laboratory Developed Tests (LDTs) announced today, outlines a risk-based approach that raises a number of questions and concerns.

"The FDA proposal adds an additional layer of regulatory requirements which may result in patients losing access to timely life-saving diagnostic services and hinder advancements in the practice of medicine.

"The AMA is committed to ensuring that the proposal that is ultimately adopted by the FDA preserves rapid access to care and medical advancements."

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Media Contact:
Randi Kahn
AMA Media & Editorial
(202) 789-7442


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