Office of Regulatory Affairs Also referred to as: ORA

The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign counterparts.

Vision

Public health is protected, promoted, and advanced

Mission

Protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products

What We Do

Recalls & Alerts

Program Areas

Import Program (Office of Import Operations)
Bioresearch Monitoring (Office of Bioresearch Monitoring Operations)
Human and Animal Food (Office of Human and Animal Food Operations)
Medical Device & Radiological Health (Office of Medical Device and Radiological Health Operations)

Other Topics

ORA Core Values

Accountability - We take personal responsibility for meeting individual, team, and organizational commitments.
Commitment to Public Health - We demonstrate our commitment to safeguarding the public health in our actions.
Communication - We provide information that is accurate and clear, and in our interactions with others, we actively listen to understand other points of view.
Inclusion, Diversity, Equity, and Accessibility - We embrace each individual’s uniqueness and seek out their ideas and perspectives.
Integrity and Respect - We adhere to the highest ethical standards by consistently being honest and trustworthy in our actions.
Quality - We set high standards of excellence for our work and take the necessary actions to continuously improve.

View ORA Compliance and Inspection Manuals

Compliance Manuals/Guides

Inspection Manuals/Guides