FDA Floats Guidance On Medical Devices For Rare Diseases

Law360, New York (March 17, 2014, 6:31 PM EDT) -- The U.S. Food and Drug Administration on Monday issued a lengthy question-and-answer document intended to clarify policies surrounding so-called humanitarian device exemptions that can ease the approval process for products targeting rare diseases.

In its 31-page draft guidance, the FDA outlined how manufacturers can qualify for a relaxed review process that’s akin to the orphan product designation covering pharmaceuticals. For devices, the streamlined pathway is reserved for ailments affecting fewer than 4,000 Americans annually.

Whereas new medical devices typically must be proven safe and effective before...
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