Breakthrough Designation Guidance Finalized

By Rachael E. Hunt — On December 18, 2018, FDA issued a final guidance document on the Breakthrough Devices Program created by the 21st Century Cures Act.  The Breakthrough Device Program is meant to speed access to new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.”  The final guidance document is largely unchanged from the October 2017 draft, which we reviewed in detail in a prior post, here. By way of background, a device must meet two criteria to qualify for participation in the Breakthrough Devices Program: The device facilitates more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions; and The device must meet one of the following criteria: Represents breakthrough technology; No cleared or approved alternatives is available on the U.S. market; Offers significant advantages over existing alternative devices; or Availability is in patients’ best…

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