Vintage, Hard-to-Find, or Out-of-Date Documents Available
Regulatory documents are published, put into use, and then updated again as the technological and political environment changes. But once a regulatory document is updated the previous version is usually removed from the web. If you didn't print out a paper copy for your files you no longer have access to it.

We offer to you here a complimentary copy of the vintage, hard-to-find, out-of-date, or obsolete (and copyright free) regulatory documents we have in our possession; listed chronologically by category. If you don't see what you want, please let us know and we'll do our best to track it down. If you have a document to share, please send it to us and we'll make it available.

• Biocompatibility
•   FDA Blue Book Memo G87-1, "Tripartite Biocompatibility Guidance," April 1987.
•   FDA Blue Book Memo D89-1, "Toxicology Risk Assessment Committee," August 1989.
•   FDA Blue Book Memo G95-1, "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices," May 1995.
•   FDA Compliance Program Guidance Manual, Chapter 48, "Good Laboratory Practice (Nonclinical Laboratories) Program 7348.808," January 2001.

• Clinical Research
•   FDA, "Guidance for Emergency Use of Unapproved Medical Devices," October 1985.
•   FDA, 510(k) Memorandum K86-3 "Guidance on the CDRH Premarket Notification Review Program," June 1986.
•   FDA Blue Book Memo D86-1, "Guidance on Significant and Nonsignificant Risk Device Studies," July 1986.
•   FDA, "Guidelines for Monitoring Clinical Investigations," January 1988.  
•   FDA/CDER, "Final Report of the Committee for Clinical Review, based on a Review of Selected Medical Device Applications," aka the "Temple Report," March 1993.
•   FDA,"Guide for Detecting Fraud in Bioresearch Monitoring Inspections," April 1993.
•   FDA Blue Book Memo D95-2, "Implementation of the FDA/HCFA Interagency Agreement regarding Reimbursement of Investigational Devices," September 1995.
•   DHHS, "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection," May 2004.
•   AHRQ, "Draft Registries for Evaluating Patient Outcomes," Publication Nr. 07-EHC001, October 2006.
•   AHRQ, "Registries for Evaluating Patient Outcomes," Publication Nr. 07-EHC001-1, April 2007.
•   AHRQ "Methods Guide for Effectiveness and Comparative Effectiveness Reviews," November 2008.

• Regulatory Affairs
•   FDA Guidance for Industry, "General/Specific Intended Use," November 1986.
•   FDA Blue Book Memo D89-1, "Review of IDEs for Feasibility Studies," May 1989.
•   FDA,"Guide for Detecting Fraud in Bioresearch Monitoring Inspections," April 1993.
•   FDA Blue Book Memo D93-1, "Overdue IDE Annual Progress Report Procedures," July 1993.
•   FDA Blue Book Memo D94-1, "IDE Refuse to Accept Procedures," May 1994.
•   FDA Memo to Staff, "Investigational Device Exemption Policy," May 1995.
•   FDA, "Goals and Initiatives for the IDE Program," July 1995.
•   FDA/CDRH, "Premarket Notification 510(k): Regulatory Requirements for Medical Devices, aka the '510(k) Manual'," August 1995.
•   FDA, "Guidance on IDE Policies and Procedures," January 1998.
•   FDA, "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications," March 1998.
•   FDA/BiMo, "Side-by-Side Comparison of Old and New BiMo Compliance Guide 7348.811," December 2008.

• Statistical
• In-vitro Diagnostics

• Institutional Review Boards
•   FDA Compliance Program Guidance Manual, Chapter 48, "Institutional Review Board[s] 7348-809," October 1994.
•   OHRP, "Categories of Research that may be Reviewed by the IRB through an Expedited Review Procedure," November 1998.
•   FDA, "Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: FAQs about Medical Devices," January 2006

Documents Wanted
CDG is looking for the following documents. If you have one, please send it to us. In return you may have your choice of a free Bio Mousepad, AE Mousepad, Date Wheel, or AE Wheel. What a deal!

• FDA Blue Book Memo K86-3, "510k Substantial Equivalence Decision-Making Process," 1986.
• FDA Draft Guidance for Industry and Staff, "Early Collaboration Meetings sUnder the FDA Modernization Act (FDAMA)," 19 February 1998.