Clinical Trials and IDE Guidance Documents

• A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry 
• Acceptance of Foreign Clinical Studies 
• Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998 
• Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy (PDF Only) (PDF - 349KB) 
• Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff 
• Computerized Systems Used in Clinical Trials 
• Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) (Text Only) 
• Draft Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions 
• Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses 
• 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 - 47KB) 
• Certification: Financial Interest and Arrangements of Clinical Investigator (PDF - 47KB) 
• Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 
• Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 
• Suggested Format For IDE Progress Report (Text Only) 
• Goals and Initiatives for the IDE Program #D95-1 (blue book memo) (Text Only) 
• Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems 
• Financial Disclosure by Clinical Investigators 
• Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials (PDF) (PDF - 68KB) 
• Guidance for Industry and FDA Reviewers: Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation 
• Guidance on IDE Policies and Procedures 
• Monitoring Clinical Investigations 
• IDE Refuse to Accept Procedures #D94-1 (blue book memo) (Text Only) 
• Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo) (Text Only) 
• Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors 
• Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (Text Only) 
• Investigators' Responsibilities For Significant Risk Device Investigations (Nov. 1995) 
• Pre-IDE Program: Issues and Answers - March 25, 1999 (D99-1) 
• Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects 
• Regulating In Vitro Diagnostic Device (IVD) Studies 
• Review of IDEs for Feasibility Studies #D89-1 (blue book memo) (Text Only) 
• Significant Risk and Nonsignificant Risk Medical Device Studies 
• Sponsor's Responsibilities For Significant Risk Device Investigations (Nov. 1995) 
• Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices 
• Suggested Content for Original IDE Application Cover Letter (Text Only) 
• Waiver for Additional Investigational Sites