Regulatory Affairs
In our “Regulatory Affairs” section you can access regulatory resources within Oregon, as well as nationwide. If you have a question about our regulatory resources or are aware of a resource that we should include, please submit it through the following: Feedback.
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Regulatory Resources
- FDA
- CDRH
- CBER
- Electronic Records/Signatures
- Division of Small Manufacturers
- GMP/Quality Systems
- Medwatch
- IRB Guidance
- Exporting Medical Devices
- Freedom of Information
- Code of Federal Regulations
- Federal Register Online
- Food, Drug, and Cosmetic Act
- Regulations.gov
- Pacific Regional Chapter of the Society of Quality Assurance
- Regulatory Affairs Professional Society (RAPS)
- American National Standards Institute
- International Organization for Standardization
- Medical Devices Agency, UK
- British Association of Research Quality Assurance
- EudraNet
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