| A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry; A Report to Congress (11/01/1999) |
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| Acceptance of Foreign Clinical Studies; Guidance for Industry (03/13/2001) |
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| Bioresearch Monitoring Agreement for PMAs and PDPs (02/23/1998) |
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| Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy (06/30/1993) |
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| Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff (05/29/2001) |
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| Computerized Systems Used in Clinical Trials (04/01/1999) |
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| Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1) (07/15/1996) |
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| Disqualified/Restricted/Assurances List For Clinical Investigators |
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| Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses (04/17/2009) |
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| Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff (02/28/2001) |
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| Financial Interest Form: Certification: Financial Interests and Arrangements of Clinical Investigations FDA Form 3454 |
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| Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 |
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| Format for IDE Progress Reports (06/01/1996) |
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| Goals and Initiatives for the IDE Program #D95-1 (blue book memo) (07/12/1995) |
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| Guidance Document for the Preparation of IDEs for Spinal Systems (01/13/2000) |
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| Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (06/25/2010) |
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| Guidance for Industry: Financial Disclosure by Clinical Investigators (03/20/2001) |
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| Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials (09/01/2005) |
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| Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers (01/16/2001) |
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| Guidance on IDE Policies and Procedures; Final (01/20/1998) |
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| Guideline for the Monitoring of Clinical Investigations (01/01/1988) |
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| IDE Refuse to Accept Procedures #D94-1 (blue book memo) (05/20/1994) |
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| 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) (09/15/1995) |
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| Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators (04/06/1998) |
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| Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (05/29/1991) |
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| Investigators' Responsibilities For Significant Risk Device Investigations (11/01/1995) |
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| New IDE / PMA Development and Review Model and Pilots |
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| Pre-IDE Program: Issues and Answers - Blue Book Memo D99-1 |
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| Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects (03/19/1999) |
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| Review of IDEs for Feasibility Studies #D89-1 (blue book memo) (05/17/1989) |
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| Significant Risk and Non-Significant Risk Medical Device Studies - D86-1 (10/01/1995) |
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| Sponsor's Responsibilities For Significant Risk Device Investigations (11/01/1995) |
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| Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices (01/01/1996) |
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| Suggested Content for Original IDE Application Cover Letter (02/27/1996) |
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| Waiver For Additional Investigational Sites (Excerpt from the IDE Form Letter to a Sponsor) (11/01/1995) |
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