About ORA
Contacts, mission, quality, jobs

Site Map/Index

Planned Events
Upcoming and recent events ...

Consumer Information
State contacts, consumer complaints ...

Federal-State Relations
Information for state and local officials, and associations ...

Industry Assistance
Device survey report, small business representatives, Small business guide ...

E-FOIA Reading Room
Electronic copies of ORA reports, FDA 483s, etc. ...

ORA U
Classroom and web-based training for ORA and other government regulators ...


ORA / Field Operations

Recent Publications

Reference

Compliance Reference
Compliance policy and programs, regulatory procedures and other documents and information.

Inspectional Reference
Investigational guidance manuals and other documents.

Science Reference
Laboratory procedures and methods, and new techniques in applied science.

Programs

Partnerships & Contracts
Information about agreements with states, federal agencies, industry, educational institutions and associations.

Import Program
Information for import brokers, wholesalers, retailers and consumers about products presented for entry into the US.

Recalls
Industry recall guidance, model recall press releases for industry, and links to recall information.

Bioresearch Monitoring (BIMO) Information for clinical and non-clinical research.

 

Hot Topics

Often Requested Documents