• 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
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry
• 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
• Guidance for Industry - Computerized Systems Used in Clinical Trials
• Guidance for Industry and FDA Staff - Investigational Device Exemption (IDE) Guidance for Retinal Prostheses
• Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
• 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
• Disclosure: Financial Interest and Arrangements of Clinical Investigators
• 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
• Guidance for Industry - Financial Disclosure by Clinical Investigators
• Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials
• Guidance for Industry and FDA Reviewers: Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation
• Guidance for Industry - Guideline for the Monitoring of Clinical Investigations
• Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo)
• Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
• Investigators' Responsibilities For Significant Risk Device Investigations (Nov. 1995)
• Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects - Guidance for Industry and FDA Staff
• In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
• Review of IDEs for Feasibility Studies #D89-1 (blue book memo)
• Significant Risk and Nonsignificant Risk Medical Device Studies
• Sponsor's Responsibilities For Significant Risk Device Investigations (Nov. 1995)