Final guidance provides additional clarity to the Humanitarian Device Exemption program

On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."

The guidance replaces the 13 June 2018 draft guidance and supersedes the 8 June 2010 "Guidance for HDE holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff, Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers."

The final guidance is largely consistent with the draft version of the guidance, formally incorporating updates to account for changes to the law made by the 21st Century Cures Act. The final guidance contains clarifying language on types of evidence appropriate to support an HDE application and probable benefit-risk assessment.

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