US Guidances

Stark NJ, ed. US Guidances 2009 Edition, Clinical Device Group Inc, Chicago, IL. eBook on secured PDF file. Link for downloadable file delivered by email; 19MB file size; Resides on your hard drive, fully searchable and easy to use. ISBN 1-889160-21-0. $175 US.

FDA has thousands of guidances and locating the ones specific for medical device clinical research insn't easy. We've done the work for you by scouring their site to download, format, bookmark, and index them into a searchable Acrobat file. Updated in spring 2008 we've included the new and discarded the old. Now you can load them onto your hard drive and take them with you in the field: easy look-up and nothing extra to carry.

Contents

Clinical Trials—Prestudy Activities
1.Review of IDEs for Feasibility Studies_1989
2.Guidance on IDE Policies and Procedures_1998
3.Early Collaboration Meetings under FDAMA_2001
4.Information Sheets…for IRBs, Investigators, and Sponsors_2006
5.Information Sheets…Frequently Asked Questions about Medical Devices_2006
6.Categories of Research [eligible for] Expedited Review Procedure_1998
7.Informed Consent Requirements for Emergency Research_2006
8.Guidelines for the Monitoring of Clinical Investigations_1988
9.Financial Disclosure by Clinical Investigators_2001
10.Financial Relationships and Interests in Research Involving Human Subjects [from HHS]_2004
11.Clinical Trial Data Monitoring Committees_2006
12.Premarket Assessment of Pediatric Medical Devices_2004
13.Patient-Reported Outcome Measures: Use…to Support Labeling Claims_2006
14.Collection of Race and Ethnicity Data_2005

Clinical Trials—Study Activities
15.Guidance on [IRB] Continuing Review_2007

Changes or Modifications to Devices
16.General to Specific Intended use_1998
17.Changes or Modifications during the Conduct of a Clinical Investigaiton_2001
18.Modifications to Devices Subject to PMA Approval-The PMA Supplement Decision-Making
Process_2008

Post-Approval Activities
19.Postmarket Surveillance under Section 522 of the FDC Act_2006
20.Postmarket Surveillance Studies Imposed by PMA Order_2007

Statistical Analysis
21.Statistical Guidance for Clinical Trials of Non-Diagnostic Medical Devices_1996
22.Statistical Guidance on Reporting Results…for Diagnostic Tests
23.Use of Bayesian Statistics in Medical Device Clinical Trials_2006

IVDs and Diagnostic Devices
24.Informed Consent for IVD Device Studies using Leftover Human Specimens that are not Individually Identifiable_2006
25.Draft IVD FAQ_2007

Bioresearch Monitoring
26.Guide for Detecting Fraud in Bioresearch Monitoring Inspectons_1993
27.BiMo Compliance Guide 7348.809 Institutional Review Boards_1994
28.BiMo Compliance Guide 7348.810 Sponsors, CROs, Monitors_2001
29.BiMo Compliance Guide 7348.811 Clinical Investigators_2001
30.Review & Inspection of PMAs under BiMo Program_2008

Software
31.21 CFR Part 11 with Preamble_1997
32.Glossary of Computerized Systems and Software Development Terminology_1995
33.Computerized Systems Used in Clinical Investigations_2007
34.Off-the-Shelf Software Use in Medical Devices_1999
35.General Principles of Software Validation_2002

Regulatory Issues
36.Acceptance of Foreign Clinical Studies_2001
37.Expedited Review of PMAs_2008
38.PMA Review Clock_2008
39.Certification [of Clinical Trial Registration] for Applications & Submissions_2009
40.Good Reprint Practices_2008
41.Disqualification Lists