Medical Devices
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Clinical Trials and IDE Guidance Documents
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A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry
November 1, 1999Acceptance of Foreign Clinical Studies
March 1, 2001Bioresearch 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)
June 30, 1993Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
May 29, 2001Computerized Systems Used in Clinical Trials
April 1, 1999Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) (Text Only) 872 Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
October 25, 2007Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses
April 17, 2009Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
February 28, 2001Certification: Financial Interest and Arrangements of Clinical Investigator (PDF - 384KB)Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF - 400KB)Suggested Format For IDE Progress Report (Text Only)
June 01, 1996Goals and Initiatives for the IDE Program #D95-1 (blue book memo) (Text Only)
July 12, 1995Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems
January 13, 2000Collection of Race and Ethnicity Data in Clinical Trials
September 1, 2005Guidance for Industry and FDA Reviewers: Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation
January 16, 2001Guidance on IDE Policies and Procedures
January 20, 1998IDE Refuse to Accept Procedures #D94-1 (blue book memo) (Text Only)
May 20, 1994Implementation 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)
September 15, 1995Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
April 06, 1998Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (Text Only)
May 29, 1991Investigators' Responsibilities For Significant Risk Device Investigations (Nov. 1995)
November 1, 1995Pre-IDE Program: Issues and Answers - March 25, 1999 (D99-1) Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects
March 19, 1999Review of IDEs for Feasibility Studies #D89-1 (blue book memo) (Text Only)
May 17, 1989Sponsor's Responsibilities For Significant Risk Device Investigations (Nov. 1995)
November 1, 1995Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices
January 1, 1996Suggested Content for Original IDE Application Cover Letter (Text Only)
February 27, 1996Waiver for Additional Investigational Sites
November 1, 1995
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