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U.S. Department of Health and Human Services

Medical Devices

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Meetings with the Regulated Industry #I89-3 (blue book Memo)

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.

 

 

    November 20, 1989     
    

    
    Meetings with the Regulated Industry
    
    Purpose.  
    
    The purpose of this memorandum is to set forth procedures to be 
    followed when meeting with representatives of medical device firms or 
    trade associations.  As a matter of practice, ODE staff has been 
    applying most of these principles for many years now, but they have 
    never been formalized in  a written policy or procedure.
    
    Applicability.
         
    The following procedures apply to all meetings with, and arranged
    by, ODE,  including its branches, divisions, the POS staffs, and
    the Office of the Director.  They also apply to meetings with ODE
    arranged by  industry. They do not apply to meetings arranged by
    other CDRH Offices, even though ODE staff members may be present.
    Other CDRH  Offices will have their own procedures to follow when
    meeting with representatives of the regulated industry.
    
    These procedures apply to "face-to-face" meetings with
    representatives or employees of the  "regulated  industry,"
    including a regulated firm or a trade or professional
    association, where the purpose of the meeting is to discuss
    issues related to an application or submission that a firm has or
    will submit to ODE or to discuss regulatory or policy issues that
    affect the regulated industry.
         
    These procedures do not apply when ODE staff attends meetings of
    a general nature, e.g., educational or scientific meetings, or
    professional conventions and trade shows where, if these topics
    are discussed, it is done at open public sessions or in other
    public areas, e.g., during coffee breaks, at convention luncheons
    and dinners,in the exhibit hall,etc.,where meeting
    participants gather to discuss scientific,professional and
    regulatory subjects of common intellectual interest. If, however,
    at such meetings,shows,and conventions,these topics are the
    subject of private meetings with ODE staff,all of the
    requirements of this memorandum apply.
    
    This memorandum does not apply to telephone conversations with an
    industry representative or employee;such contacts  will be the 
    subject of a subsequent memo.
                                                                     
    Unplanned meetings that do not conform to the requirements of this 
    memorandum,  i.e., "walk-in"  meetings, are  to be  strongly
    discouraged.  Such meetings may occur when, for example, a firm's
    representative is already in an ODE office at a properly
    scheduled meeting and may want to drop off information that has
    been requested, seek clarification about a policy or procedure,
    etc.  This may be proper on an occasional basis. It should not be
    a common occurrence. Walk-in meetings should not be used to discuss 
    the firm's pending or forthcoming submissions or other substantive  
    issues concerning the firm without meeting the requirements of this 
    memorandum.
           
    Procedures.
                
    For all "face-to-face" meetings with the regulated industry,the
    following procedures are to be followed:
           
      1. Agenda.  An agenda specifying the purpose of the meeting,
      the issues to be discussed, and the individuals who will be in
      attendance will be prepared prior to the meeting,and a copy
      placed in a division file set up for that purpose and, if
      applicable, a copy put in the file(s) of the submission(s) to
      be discussed.
           
      2. Escorting  Visitors.   All non-HHS visitors coming to ODE offices 
      for meetings should be met at the main lobby on the first floor or at 
      the   elevator lobby on the second floor by member of the division or   
      office being visited and the visitor escorted to the sign-in log and     
      then to the meeting room.  No visitors should be left to wander     
      around alone.  If a visitor has to go to a second ODE office after     
      the first meeting, he or she should be escorted there.
      
      3. Sign-in Log.  All non-HHS visitors coming to ODE offices for
      meetings should sign a visitors' log and record his or her name, the     
      name of the firm or organization represented,the name of the ODE     
      employee being visited, and the purpose of the visit.  This log   
      should be maintained by each office, division, and staff, for visits   
      to each of their areas.
                
      4. Meeting  Room.  Preferably,all meetings with industry
      representatives should be conducted in an ODE or CDRH
      conference room.  There are four ODE conference rooms plus
      conference rooms elsewhere (Office of Compliance and
      Surveillance) in the Piccard Building.  You can reserve an ODE
      conference room for a meeting through the PMO office.  In the
      unlikely event that a conference room is not available,
      meetings may be held in the office of a division or staff
      director, branch chief, or office director. In such a case, it
      is important that official FDA documents be protected from
      casual or intentional viewing by visitors.  Because of the
      large number of documents being worked on by reviewers,
      visitors should not be brought into reviewers' offices.
      
      5.  ODE Attendees.  At all meetings with the regulated industry,
      in addition to the primary reviewer who will be in attendance,
      the Branch Chief,Staff Director,or Division Director should
      be present,or,if none of these is available, at least one
      other ODE reviewer or Center staff member, e.g., OST scientist,
      should be present. The POS Director, Division Director or the
      Office Director may meet alone with a representative  of the
      regulated industry if the purpose of the meeting is to discuss
      a management issue or personnel matter and the  topics
      identified above are not discussed at the meeting.
           
      6. Minutes.  An ODE staff member present at the meeting should
      take notes of the discussion and prepare minutes of the
      meeting. These minutes should meet the generally accepted
      standard for preparation of minutes. They should be complete
      and concise and represent what transpired at the meeting. They
      should not be so detailed as to constitute a transcript of the
      meeting. The minutes should be reviewed and initialed by a
      supervisor. A copy should be placed in a division, office, or
      staff file set up for that purpose and,if appropriate, a copy
      put in the file(s) pertaining to the document(s) discussed at
      the meeting.
                
      7. Document Security.  All ODE offices, and especially common
      areas where visitors are likely to be, should be kept secure to
      minimize the risk of casual or intentional viewing of official
      FDA documents, especially, but not limited to, PMAs, IDEs, and
      510(k)s.
           
      Effective Date.
                
      This policy is effective immediately.