📄FDA Issues Guidance on Conducting Remote Regulatory Assessments
Conducting Remote Regulatory Assessments-Questions and Answers; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Conducting Remote Regulatory Assessments--Question and Answers." The final guidance describes FDA's current thinking regarding its use of remote regulatory assessments (RRAs) and provides answers to frequently asked questions. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help evaluate compliance of FDA- regulated products with applicable regulatory requirements.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines the FDA's guidance on remote regulatory assessments (RRAs), impacting compliance requirements for businesses dealing with FDA-regulated products. This indicates a shift in regulatory practices that businesses must adapt to, which could involve additional costs and adjustments in operations to ensure compliance.