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Assignment of Review Documents
August 24, 1990 (I90-2)

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This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.


Program Integrity Memorandum #I90-2 

    August 24, 1990
    
    Assignment of Review Documents
    
    Purpose.  
    
    The purpose of this memorandum is to set forth procedures for the 
    assignment of review documents (PMAs, PMA supplements and amendments, 
    IDEs, IDE supplements and amendments, and 510(k)s) to ODE staff.  It 
    also covers reassignment of such documents from primary reviewers to 
    other reviewers.  Accordingly, this memorandum supersedes and 
    replaces Integrity Memorandum #I89-2, entitled "Reassignment of 
    Review Documents".

    Assignment of Review Documents.  
    
    Review documents may be assigned by the Branch Chief or the Division 
    Director to a specific reviewer based on the following factors:
    
         -    the professional or scientific expertise of that reviewer 
              is required for the device that is the subject of the 
              submission;
    
         -    the reviewer has previous experience and knowledge of the 
              issues related to that submission;
    
         -    that reviewer has reviewed prior submissions, e.g., an 
              earlier IDE for that device;
    
         -    the reviewer to whom the application is assigned is the 
              reviewer most familiar with that manufacturer's 
              submissions;
    
         -    the workload of other reviewers in the branch is 
              proportionately greater than the workload of the reviewer 
              to whom the assignment is-being made; or, 
    
         -    the assignment of the submission will offer a special 
              training experience to the reviewer who otherwise might not 
              have such an opportunity.
                                      
    Reassignment of Review Documents.  
     
    Whenever a review document is reassigned from the primary reviewer to 
    another reviewer, who will be the new primary reviewer, the 
    supervisor making the reassignment shall include, in that document's 
    folder, a statement of the reasons for the reassignment.  All such 
    reassignments must have the concurrence of the Division Director, who 
    should initial the written explanation of the reassignment. There are 
    many valid reasons for reassignment.  For example, the primary 
    reviewer may be going on extended leave and the document cannot wait 
    for the reviewer's return.
    
    Collateral Reviews.  
    
    You should keep in mind that these procedures, as they relate to 
    assignment and reassignment or review documents, do not apply to the 
    referral of a document to another ODE reviewer or to another office 
    within the Center for scientific, professional, or other special 
    review, e.g., referral of the document to the Office of Science and 
    Technology for review, if the document will be returned
    to the original, primary reviewer for completion.  We do not want 
    this policy to interfere with the "team approach": to document 
    review.  Any specialized review that is necessary should be obtained.

    Document Transfers.  
    
    This policy also does not apply to the transfer of a document to 
    another office outside of the Center.  For example, if a document 
    applies to a product that is determined to be a drug, the document 
    would be transferred to the CDER and it would be logged out of ODE 
    via another mechanism by the appropriate POS staff.
    
    Program Operation Staff.  
    
    This memorandum does not apply to reassignments within the POS staff 
    offices which provide oversight and quality control reviews and which 
    do not provide primary document reviews.
    
    Effective Date  
    
    This policy is effective immediately.

Updated 5/30/1996

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