Clinical Trials and IDE Guidance Documents

A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry; A Report to Congress (11/01/1999)

Acceptance of Foreign Clinical Studies; Guidance for Industry (03/13/2001)

Bioresearch Monitoring Agreement for PMAs and PDPs (02/23/1998)

Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy (06/30/1993)

Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff (05/29/2001)

Computerized Systems Used in Clinical Trials (04/01/1999)

Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1) (07/15/1996)

Disqualified/Restricted/Assurances List For Clinical Investigators

Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses (04/17/2009)

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff (02/28/2001)

Financial Interest Form: Certification: Financial Interests and Arrangements of Clinical Investigations FDA Form 3454

Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455

Format for IDE Progress Reports (06/01/1996)

Goals and Initiatives for the IDE Program #D95-1 (blue book memo) (07/12/1995)

Guidance Document for the Preparation of IDEs for Spinal Systems (01/13/2000)

Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (06/25/2010)

Guidance for Industry: Financial Disclosure by Clinical Investigators (03/20/2001)

Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials (09/01/2005)

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)

Guidance on IDE Policies and Procedures; Final (01/20/1998)

Guideline for the Monitoring of Clinical Investigations (01/01/1988)

IDE Refuse to Accept Procedures #D94-1 (blue book memo) (05/20/1994)

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)

Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators (04/06/1998)

Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (05/29/1991)

Investigators' Responsibilities For Significant Risk Device Investigations (11/01/1995)

New IDE / PMA Development and Review Model and Pilots

Pre-IDE Program: Issues and Answers - Blue Book Memo D99-1

Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects (03/19/1999)

Review of IDEs for Feasibility Studies #D89-1 (blue book memo) (05/17/1989)

Significant Risk and Non-Significant Risk Medical Device Studies - D86-1 (10/01/1995)

Sponsor's Responsibilities For Significant Risk Device Investigations (11/01/1995)

Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices (01/01/1996)

Suggested Content for Original IDE Application Cover Letter (02/27/1996)

Waiver For Additional Investigational Sites (Excerpt from the IDE Form Letter to a Sponsor) (11/01/1995)