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Device Advice: Comprehensive Regulatory Assistance
How to Market Your Device
Investigational Device Exemption (IDE)
IDE Definitions and Acronyms
IDE Approval Process
IDE Responsibilities
IDE Application
IDE Reports
IDE Records
IDE Institutional Review Boards (IRB)
IDE Informed Consent
IDE Financial Disclosure
IDE Early/Expanded Access
IDE Enforcement of Good Clinical Practices (GCP) Regulations
Import and Export of Investigational Devices
FAQs about IDE
IDE Related Topics
IDE Guidance
IDE Regulations
IDE Links
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IDE Regulations
Regulations pertaining to the Investigational Device Exemptions (IDE)
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References:
21 CFR 812 - Investigational Device Exemptions
21 CFR 50 - Protection of Human Subjects
21 CFR 56 - Institutional Review Boards
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 58 – Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR 820 - Quality System Regulation
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