Links and Information

Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products. Below are selected resources that provide a basic overview.

1. Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA

2. Advancing Regulatory Science at FDA: A Strategic Plan (August 2011)

3. Moving Regulatory Science into the 21st Century

4. Advancing Regulatory Science for Public Health

5. The Role of the FDA in Ensuring Device Safety

6. National Evaluation System for health Technology (NEST)

7. Improving Diagnosis in Health Care

8. Laboratory Quality Management System Handbook