Due to the 2024 FDA reorganization, ORA Lab Manual has been updated to reflect the organizational changes. The copy below is archived and is not being updated but will continue to be available at this location. For the new FDA Regulatory Testing Laboratory Manual of Quality Policies, please visit Laboratory Manual of Quality Policies.
ORA Laboratory Manual
Introduction
The Laboratory Manual is a reference manual for ORA laboratory personnel and supporting units. It provides personnel with information on internal policies and procedures to be used for testing consumer products, training laboratory staff, writing reports, safety, research, review of private laboratory reports, court testimony, and other laboratory activities. (Formerly: Laboratory Procedure Manual)
- The ORA Laboratory Manual is approved by the Director of the Office of Regulatory Science, the Deputy, or a designee. Approval records are maintained on file.
Volume I – Manual of Quality Policies (ISO 17025 Requirements
Volume II – Management System Policies and Procedures
Volume II – Technical Policies and Procedures
Volume III – Laboratory Operations, Applications and Programs
Volume IV – Laboratory Training
Contact
For assistive needs regarding these documents please contact: ORALABManualEditorialBoard@fda.hhs.gov
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Content current as of:
07/29/2025
