June 13, 2024
Ensuring Safety through Rigorous Oversight
The FDA’s Office of Regulatory Affairs (ORA) employs a robust, risk-based approach to safeguard the safety of foods, drugs, and medical products in the United States. This strategy encompasses several key areas:
- Inspections and Investigations:
- Regular inspections of food and drug facilities both domestically and internationally.
- Criminal investigations to tackle fraudulent activities that pose health risks.
- Laboratory testing of potentially hazardous products.
- Screening and Assessments:
- Vigilant screening of all imports of food, drugs, and medical products.
- Remote Regulatory Assessments (RRAs) during the COVID-19 pandemic to maintain industry compliance.
- Collaboration and Information Sharing:
- Domestic Mutual Reliance to leverage information from trusted foreign regulatory partners.
- Utilizing mutual recognition agreements for drugs and the single audit program for medical devices.
- Systems recognition for foods to ensure safety through international cooperation.
Adaptation During the COVID-19 Pandemic
The pandemic necessitated significant adaptations by the ORA to continue its mission:
- Enhanced use of remote surveillance tools.
- New oversight approaches to protect public health while minimizing COVID-19 risks.
The Resiliency Roadmap for FDA Inspectional Oversight highlighted