Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (blue book memo) (Text Only)

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.

Guidance Memorandum - G93-1

     Acting Director
     Office of Device Evaluation
     
     Documentation and Resolution of Differences of Opinion on Product 
     Evaluations
     
     ODE Review Staff
     Through:  ODE Branch Chiefs

     
     Purpose
     
     This guidance memorandum describes the respective roles of Center staff 
     members that review, consult on, or otherwise provide input on a review 
     document, other FDA employees, special government employees, supervisors 
     and management in the document review processes for 510(k)s, IDEs, and 
     PMAs and states how institutional positions are reached on review 
     decisions.  The guide also indicates how each person in the review chain 
     is to document his or her views and the procedure for resolution of 
     differences of opinion when these arise.
     
     Background
     
     The review processes for 510(k)s, IDEs, and PMAs are the procedures by 
     which CDRH reaches an institutional evaluation of the approvability of 
     device applications submitted to it.  The review process is easy to 
     describe in concept even though it is complex in practice.  Applications 
     are reviewed either by individual reviewing scientists or by teams of 
     reviewing scientists, and each of these primary reviews is in turn 
     approved by a supervisor.  These reviews, plus a draft action letter 
     reflecting the joint lower level recommendations, are then reviewed by 
     the Division Director or the Director of the Office of Device Evaluation 
     for final approval and action.
     
     It is inevitable, indeed intended, that reviewers, supervisors, and 
     management will bring different perspectives and concerns to their 
     respective analyses of the information in a 510(k), IDE, or PMA.  As a 
     result, it is necessary for reviewers, supervisors, and management to 
     work together to resolve differences when they occur so that an 
     institutional position on the application can be reached.  The basic 
     approach to accomplishing this it to attempt consensus development 
     through discussion between or among reviewing participants as the review 
     proceeds.  In cases where consensus is not reached, resolution of 
     differences by management is necessary.
    
     It is essential that the views of all persons involved in the review of a 
     device be respected and that the administrative file on the application 
     reflect differences of opinion when they exist and the ultimate 
     resolution of the differences.
     
     Review and Procedures
     
     A.  FDA Requirements on Documentation of the Administrative Record and 
          Files.
     
         FDA's Administrative Practices and Procedures Regulations, provides 
         that all FDA employees responsible for handling a matter are also 
         responsible for insuring the completeness of the administrative file.  
         See 21 CFR 10.70.  The file must contain appropriate documentation of 
         the basis for a decision, including relevant reviews and memoranda, 
         checklists and flowcharts, opinions of consultants, letters and 
         memoranda of meetings.  It must also contain the recommendations and 
         decisions of individual employees, including supervisory personnel 
         and managers.  The file must reflect significant controversy or 
         differences of opinions, if they exist, and their resolution.  These 
         regulations also require that all documents placed in an 
         administrative file relate to the factual, scientific, or regulatory 
         issues under consideration.  
     
         Each document in the administrative file must include the following 
         information:  
     
              1)  date(s) and signature(s) of the author(s);
              2)  "prepared by:" with date(s) of preparation, when 
                   appropriate;
              3)  "revised by:" with date(s) of revision, when appropriate; 
                   and
              4)  full distribution.
     
         In addition, a copy of any document that records the views, analyses, 
         recommendations or decisions of an agency employee other than the 
         author must be provided to that person.
     
         Written reviews and minutes in an administrative file must avoid 
         intemperate language, undocumented charges or irrelevant remarks 
         (e.g., personnel complaints).  Once completed (i.e., typed in final 
         form, dated, and signed), reviews, memoranda and accompanying 
         checklists and flowcharts may not be removed from the record.  
         Subsequent, brief amendments (corrections, revisions, additions, 
         notes, comments, recommendations) may be made directly on the 
         document, but must be initialed, or signed, and dated; longer 
         amendments should be made in a new document, with date and signature.  
         Private memoranda that are not included in the official file have no 
         status or effect.

         Special mention must be made of electronic files.  Until an agency 
         policy is formulated to take electronic files into consideration, FDA 
         files may not be considered complete until there is a paper copy as 
         part of the record.
     
     B.  Roles of Reviewers, Supervisors, and Management.
     
         A scientific review of a 510(k), IDE or PMA shall be considered a 
         reviewer's own work.  In the course of creating his or her review, it 
         is anticipated that the reviewer may develop successive drafts or 
         alter the primary draft, with the intent of clarifying points or 
         improving the review.  This may occur as a result of discussions with 
         the supervisor, other members of the review team, consultants, or 
         others.  The thoughtful reviewer will consult freely with his or her 
         supervisor during a review, particularly if the application presents 
         complex scientific or policy issues.  In turn, the thoughtful 
         supervisor will advise freely with the intent of assisting the 
         reviewer in evaluating the data in the application.  In the course of 
         doing this, supervisors may comment on or edit drafts, if so 
         requested by the reviewer, in the spirit of providing assistance or 
         raising points for discussion.  In the event of a disagreement, 
         however, the supervisor may not order a draft review to be changed; 
         final responsibility for the content of the review rests with the 
         reviewer.
     
         A supervisor's concurrence with a review, usually indicated by 
         initials or a signature at the end of the review, should be 
         interpreted to mean (i) that the supervisor finds the review to be in 
         the required format and to meet all applicable review guidelines; 
         (ii) that the supervisor believes it is complete and has considered 
         the critical scientific and regulatory issues; and (iii) that the 
         supervisor agrees with all of the conclusions and recommendations.  
     
         In the event a supervisor feels such concurrence cannot be given, in 
         part or in whole, the supervisor must discuss this with the reviewer.  
         It is unacceptable to use a form of notation that can be removed, 
         such as "Post-Its" notes, for such purposes.  If the matter is 
         resolved, a memorandum may be added to the file, as appropriate, 
         indicating the agreement reached.  If a difference remains, i.e., if 
         the reviewer and supervisor "agree to disagree" the supervisor must 
         forward to the Division Director or the Director's designee, e.g., an 
         Associate Division Director, the review (and any additional memoranda 
         prepared by the reviewer) plus the supervisor's own memorandum 
         stating the alternative analyses, conclusions, or recommendation he 
         or she supports and the reason for these judgments.  
     
         Responsibility for resolving differences between a reviewer and the 
         supervisor rests with the Division Director or his/her designee, who 
         must meet with the reviewer and supervisor, preferably together, 
         consider the merits of both points of view, and decide the issue if 
         consensus cannot be achieved.

         The Division Director is to evaluate the entire review package, 
         including all scientific reviews and recommendations, and other 
         memoranda, and to determine the appropriate action that should be 
         taken.  If the issues to be resolved concern the appropriateness of 
         the administrative action to be taken and does not involve the 
         substantive scientific aspects of the review, the authorized official 
         may render a decision and merely make an appropriate supporting 
         notation, dated and initialed, in the file.  If, on the other hand, 
         the issues relate to the substantive scientific evaluation of the 
         submission and the official elects not to accept or act on a 
         particular recommendation or takes an action contrary to the 
         recommendation, the official must state the reasons for the decision 
         in a memorandum to the file.
     
         The concurrence of the official having the delegated authority for 
         such decisions is indicated by signing the action letter to the 
         applicant.  The official signing the action letter is personally 
         responsible for assuring that it is scientifically accurate, 
         consistent with agency regulations and policy, correct in tone, and 
         written clearly in good English.  The signing official is also 
         responsible for assuring that it represents the institutional 
         position of the agency.  

         The resolution of a difference between a manager and a subordinate is 
         the responsibility of the next higher level of management.  
         Ordinarily such differences will be resolved at the Division Director 
         level.  In the rare case where an appeal above the Division Director 
         level is necessary, the matter should be referred to the Director, 
         Office of Device Evaluation.
     
         As a matter of operating policy, both the Center Director's office 
         and the Commissioner's office also maintain an open-door policy for 
         the appeal by any employee of a policy issue that the employee feels 
         should be brought to their attention.  Such appeals should be sent 
         directly to the Director of ODE or CDRH or the Commissioner and may 
         by-pass usual channels.  Citizens petitions under  21 CFR 10.30 may 
         also be used for this purpose, but should not be necessary.
     
     C.  Personal Obligations of Staff:
     
         The intent of this guidance is to promote thoughtful and independent 
         scientific reviews, effective communication among reviewers, 
         supervisors and management, and good human relationships in reaching 
         institutional positions.  It is also important to have a record of 
         individual accountability in institutional decision-making.  When 
         differences arise, discussion is to be handled in the spirit of open 
         communication and without personal animosity.  All reviewers and 
         supervisors have an obligation to identify and bring to management's 
         attention those developing controversies that may require resolution 
         through internal meetings, policy guidance, presentation to an 
         advisory committee, presentation at rounds, consultation with ODE or 
         CDRH line management or the Commissioner's office.  Effective 
         communication at an early stage is the best approach to resolving 
         differences.  Managers in turn have an obligation to meet with the 
         reviewer or the review team and supervisors as necessary to work out 
         problems and to create an atmosphere of openness, trust, and respect 
         for each other's views in resolving differences.
     
     Effective Date
     
     This memorandum is effective immediately.
     
     
     
     
                                       Susan Alpert, Ph.D., M.D.