AMA urges FDA to withdraw LDT guidance

The American Medical Association (AMA) submitted comments to FDA urging the agency to withdraw its proposal to implement a new regulatory framework for laboratory developed tests (LDTs). AMA argued that FDA's plans for LDT regulation would stifle innovation and compromise patient access to testing services and procedures.

AMA CEO and EVP James Madara said in a statement that FDA has not shown evidence that would justify regulatory changes, nor does it have the statutory authority to regulate physician services and procedures. He said the agency lacks the resources "to successfully implement its proposal without impeding on [sic] the current standard of care and creating marked delays in medical advancement." ...