AMA calls for FDA to alter lab developed testing services regulation in the name of innovation

The FDA has released a proposed regulatory framework for laboratory developed testing services and procedures, but the American Medical Association is arguing these regulations would hamper medical innovation.

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“The FDA has offered little evidence of systemic test failure that would justify these sweeping regulatory changes and it does not have the statutory authority to regulate physicians engaged in the practice of medicine as it is proposing,” said CEO and Executive Vice President of the American Medical Association, James L. Madara, MD. “The agency also does not have the resources to successfully implement its proposal without impeding on the current standard of care and creating marked delays in medical advancement.”

Click here to read the AMA’s submitted comments in full.

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