Humanitarian Use Device Laws, Regulations, and Guidances

The supporting laws, regulations, and guidances that comprise the mission and scope of the Office of Orphan Products can be found in the following documents:

Humanitarian Use Device Guidances

• Guidance for Industry and FDA Staff - Humanitarian Use Device (HUD) Designations

Humanitarian Use Device Laws

• 21st Century Cures Act 2016

• Food and Drug Administration Safety and Innovation Act (FDASIA) 2012

• Food and Drug Administration Amendments Act (FDAAA) of 2007

• FDA Backgrounder on FDAMA 1997

• HDE - Safe Medical Device Act 1990

Humanitarian Use Device Regulations

• Current Regulations: 21CFR 814 Subpart H: Humanitarian Use Devices - Revised as of April 1, 2020

• 21CFR 814 Subpart H: Humanitarian Use Devices 2004

• Federal Register Final Rule- 1996

• HUD Final Rule - November 3, 1998