FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.
These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public.
Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations.
These programs are intended for FDA personnel but are made available electronically to the public as they become available.
FDA’s Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.
FDA's Compliance Programs are organized by the following program areas:
- Biologics (CBER)
- Bioresearch Monitoring (BIMO)
- Devices/Radiological Health (CDRH)
- Drugs (CDER)
- Food and Cosmetics (CFSAN))
- Veterinary Medicine (CVM)
Compliance Programs are made available to the public under the Freedom of Information Act.
Freedom of Information
The 1996 amendments to the Freedom of Information Act (FOIA) mandate publicly accessible "electronic reading rooms" with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.
Requesters can now submit a FOIA request online.
Please note that requests for 510K, PMA, and De novo records are complex requests and take approximately 18-24 months to process.
