Off-Label Use of Medical Devices in Radiology: Regulatory Standards and Recent Developments

The US Food and Drug Administration (FDA) enjoys a broad legal mandate to ensure that medical products are safe and effective for their intended uses, authority that extends to the medical devices that make modern radiology possible. Under FDA's regulatory framework, medical devices are cleared or approved for specific indications for use that are described in the labeling provided with the devices. This article outlines this framework as well as the regulatory and legal implications of using medical devices in a manner inconsistent with their FDA-cleared or FDA-approved labeling.

Key Words: FDA, FDCA, off-label use, medical device, premarket approval process