A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry; A Report to Congress (11/01/1999)
http://www.fda.gov/cdrh/modact/113b.html
http://www.fda.gov/cdrh/modact/113(b)final.pdf
Acceptance of Foreign Clinical Studies; Guidance for Industry (03/13/2001)
http://www.fda.gov/cder/guidance/fstud.htm
http://www.fda.gov/cder/guidance/fstud.pdf
Bioresearch Monitoring Agreement for PMAs and PDPs (02/23/1998)
http://www.fda.gov/cdrh/ode/p98-1.html
Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy (06/30/1993)
http://www.fda.gov/cdrh/ode/4859.pdf
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff (05/29/2001)
http://www.fda.gov/cdrh/ode/guidance/1337.html
http://www.fda.gov/cdrh/ode/guidance/1337.pdf
Computerized Systems Used in Clinical Trials (04/01/1999)
http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm
http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf
Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1) (07/15/1996)
http://www.fda.gov/cdrh/d961.html
Disqualified/Restricted/Assurances List For Clinical Investigators
http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm
Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses (04/17/2009)
http://www.fda.gov/cdrh/ode/guidance/1651.html
http://www.fda.gov/cdrh/ode/guidance/1651.pdf
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff (02/28/2001)
http://www.fda.gov/cdrh/ode/guidance/310.html
http://www.fda.gov/cdrh/ode/guidance/310.pdf
Financial Interest Form: Certification: Financial Interests and Arrangements of Clinical Investigations FDA Form 3454
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3454.pdf
Financial Interest Forms: Disclosure: Financial Interests and Arrangements of Clinical Investigators FDA Form 3455
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3455.pdf
Format for IDE Progress Reports (06/01/1996)
http://www.fda.gov/cdrh/dsma/311.html
Goals and Initiatives for the IDE Program #D95-1 (blue book memo) (07/12/1995)
http://www.fda.gov/cdrh/d951.html
Guidance Document for the Preparation of IDEs for Spinal Systems (01/13/2000)
http://www.fda.gov/cdrh/ode/87.html
http://www.fda.gov/cdrh/ode/87.pdf
Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (06/25/2010)
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071230.pdf
Guidance for Industry: Financial Disclosure by Clinical Investigators (03/20/2001)
http://www.fda.gov/oc/guidance/financialdis.html
Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials (09/01/2005)
http://www.fda.gov/cder/guidance/5656fnl.htm
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)
http://www.fda.gov/cdrh/ode/guidance/1164.html
http://www.fda.gov/cdrh/ode/guidance/1164.pdf
Guidance on IDE Policies and Procedures; Final (01/20/1998)
http://www.fda.gov/cdrh/ode/idepolcy.html
http://www.fda.gov/cdrh/ode/idepolcy.pdf
Guideline for the Monitoring of Clinical Investigations (01/01/1988)
http://www.fda.gov/ora/compliance_ref/bimo/clinguid.html
IDE Refuse to Accept Procedures #D94-1 (blue book memo) (05/20/1994)
http://www.fda.gov/cdrh/d941.html
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)
http://www.fda.gov/cdrh/d952.html
Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators (04/06/1998)
http://www.fda.gov/oc/ohrt/irbs/default.htm
Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (05/29/1991)
http://www.fda.gov/cdrh/i91-2.html
Investigators' Responsibilities For Significant Risk Device Investigations (11/01/1995)
http://www.fda.gov/cdrh/manual/invest.html
New IDE / PMA Development and Review Model and Pilots
http://www.fda.gov/cdrh/pmat/pmathome.html
Pre-IDE Program: Issues and Answers - Blue Book Memo D99-1
http://www.fda.gov/cdrh/ode/d99-1.html
http://www.fda.gov/cdrh/ode/d99-1.pdf
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects (03/19/1999)
http://www.fda.gov/cdrh/comp/2229.html
http://www.fda.gov/cdrh/comp/2229.pdf
Review of IDEs for Feasibility Studies #D89-1 (blue book memo) (05/17/1989)
http://www.fda.gov/cdrh/d891.html
Significant Risk and Non-Significant Risk Medical Device Studies - D86-1 (10/01/1995)
http://www.fda.gov/cdrh/d861.html
Sponsor's Responsibilities For Significant Risk Device Investigations (11/01/1995)
http://www.fda.gov/cdrh/manual/sponsor.html
Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices (01/01/1996)
http://www.fda.gov/cdrh/ode/odeot476.html
Suggested Content for Original IDE Application Cover Letter (02/27/1996)
http://www.fda.gov/cdrh/dsma/797.html
Waiver For Additional Investigational Sites (Excerpt from the IDE Form Letter to a Sponsor) (11/01/1995)
http://www.fda.gov/cdrh/manual/waiver.html