FDA Clarifies Review Practices for the Humanitarian Device Exemption Program

Published: 06/12/2018

  • Food and Drug Administration
Relevant To:
  • Critical Access Hospitals,
  • Hospitals

The U.S. Food and Drug Administration (FDA) has released draft guidance “Humanitarian Device Exemption (HDE) Program” to answer common questions about the HDE program including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the HDE Program. The FDA believes sharing this information with medical device manufacturers and healthcare systems will help increase the development of medical devices intended for diseases or conditions t

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