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Vaccines, Blood & Biologics

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SOPP 8717: Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices

Version #1

Effective Date: Jan. 13, 2005


  1. Purpose
  1. The purpose of this document is to describe the procedures for CBER staff to follow when reviewing required biocompatibility toxicology information submitted in any device submission.
  2. Background
  3. The Center for Devices and Radiologic Health (CDRH) standardizes the review of Investigational Device Exemptions (IDE), Premarket Notification (510(k)), and Premarket Approval (PMA). premarket notifications by issuing review procedures for staff to follow. The Center for Biologics Evaluation and Research (CBER) also reviews and clears premarket notifications under the same authority, FD&C Act.

    In an effort to harmonize review principles and procedures between centers, CBER has decided to adopt existing CDRH procedures, also known as Blue Book Memoranda, when feasible. When CBER cannot directly adopt existing CDRH procedures, e.g., because of issues related to a specific CBER regulated device, CBER will prepare an SOPP based on CDRH review principles with adjustments for CBER-regulated devices. In either case, CBER will issue an SOPP for staff to follow.

  1. Policy
  1. CBER staff will conduct a review of biocompatibility and toxicology information relating to medical devices in accordance with the CDRH Blue Book Memorandum: Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, issued on May 1, 1995 (G95-1), with changes limited to CBER-specific administrative procedures.
  1. Responsibilities and Procedures
  1. CBER staff will incorporate review procedures contained in the CDRH Blue Book Memorandum: Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 (G95-1), with changes limited to CBER-specific administrative procedures, when reviewing biocompatibility and toxicology information relating to medical devices.

    The attached Blue Book Memoranda (BBM) version has been approved for CBER review purposes by Center management. Revisions to this BBM will need CBER management approval prior to implementation. Thus, reviewers should access this BBM only through this SOPP to ensure CBER review process integrity is maintained.

     

  1. Appendix
  1. Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 (G95-1)
  1. Effective Date
  1. January 13, 2005
  1. History
    Comment / Revision
    Approved By
    Approval Date
    Version Number
    Comment
    Len Wilson Robert A. Yetter, PhD
    1/13/2005
    1
    Original version Written by RMCC Device Review Subcommittee