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