Clinical Trials and IDE Guidance Documents

• FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 573KB)
• Guidance for Sponsors, Investigators, and Institutional Review Boards – Questions and Answers on Informed Consent Elements 21 CFR 50.25(c) (PDF - 56KB)
• FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions
• Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998
• Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
• Computerized Systems Used in Clinical Investigations, Guidance for Industry (PDF - 53KB)
• Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB)
• Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
• Certification: Financial Interest and Arrangements of Clinical Investigator (PDF) (PDF - 673KB)
• Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF - 673KB)
• Financial Disclosure by Clinical Investigators - Guidance for Clinical Investigators , Industry, and FDA Staff (PDF - 165KB)
• Suggested Format For IDE Progress Report
• Collection of Race and Ethnicity Data in Clinical Trials - Guidance for Industry and FDA Staff (PDF - 896KB)
• Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
• Investigators' Responsibilities For Significant Risk Device Investigations (Nov. 1995)
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects - Guidance for Industry and FDA Staff (PDF - 26KB)
• Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.3MB)
• Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF - 211KB)
• Sponsor's Responsibilities For Significant Risk Device Investigations (Nov. 1995)
• FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 631KB)
• Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (PDF - 402KB)
• eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff (PDF - 525KB)
• Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 163KB)
• Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163KB)