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U.S. Department of Health and Human Services

Medical Devices

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Telephone Communications Between ODE Staff and Manufacturers #I93-1 (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.

 

Integrity Memorandum I93-1

 

 

January 29, 1993
                                      Integrity Memorandum #I93-1
Acting Director
Office of Device Evaluation

Telephone Communications Between ODE Staff and 
Manufacturers

ODE Review Staff
Through:  ODE Branch Chiefs


Purpose

The purpose of this memorandum is to establish efficient and 
effective written procedures concerning telephone communications 
between manufacturers and other third parties and ODE staff 
members.  The primary purpose of these procedures is to enable 
ODE personnel to use the telephone to request or obtain 
information necessary in the review of submissions without 
compromising the integrity of program activities. 

Background

Over the years, ODE has had a liberal policy of open telephone 
communications between manufacturers and staff members in order 
to facilitate the review process.  The use of the telephone 
permitted the rapid clarification of minor questions that would 
have taken much longer to resolve via written correspondence.  
This process contributed to overall efficiency in the review of 
submissions and reduced review times.  

Over this same period of time, we have experienced an increase in 
the number of incoming calls initiated by manufacturers.  In 
recent years, many of the calls from manufacturers have been to 
reviewers to determine the status of submissions and, because of 
the volume of such calls, they have become counterproductive.  
Also, a call to the reviewer that starts out as a status inquiry 
can turn into a discussion of the merits of the submission or a 
lobbying effort by the manufacturer's representative to obtain a 
favorable decision or to have a decision made by a specific time.  
In addition to being a counterproductive use of limited review 
time, these types of telephone calls generally are inappropriate 
because the reviewer is asked to discuss an application without 
notice and, in addition, they are not fair to other manufacturers 
who have not called and are patiently awaiting their turn in the 
review process.

In addition, the agency has become increasingly concerned about 
inappropriate contact between reviewers and manufacturers in 
light of the recent unlawful gratuity cases in another agency 
program.  The agency is also concerned about the release of 
financially sensitive information to unauthorized third parties, 
such as financial analysts, stock brokers, etc., who may use such 
information for financial gain through, for example, stock 
manipulation.

In order to avoid any appearance of favoritism, to prevent the 
types of problems that have been experienced elsewhere in the 
agency, and to re-establish the proper use of telephone 
communications between ODE staff and manufacturers, the following 
guidance is being adopted.

Telephone Policies and Procedures

       A.  Telephone Calls Concerning Pending Applications

1.  ODE staff members may telephone manufacturers to obtain 
clarification or to request additional information concerning 
submissions under review.  

    ODE staff members (i.e., managers, supervisors, and 
    reviewers) may telephone manufacturers (i.e., employees of 
    manufacturers, their outside consultants, attorneys, and 
    others who are authorized to speak on behalf of a 
    manufacturer) to request, and obtain via telephone, 
    clarification of information contained in a submission such 
    as nonsubstantive inconsistencies, typographical errors, 
    organization of the submission, interpretation of a graph or 
    chart and other similar matters.  The firm may supply the 
    requested information by telephone and would not have to 
    submit this information in writing.  Obtaining such 
    clarification via telephone does not affect the official 
    review clock.

    ODE staff members may telephone manufacturers to request 
    minor additions of information or minor changes to a 
    submission, such as a change in the labeling, a change in the 
    instructions or a change in the 510(k) summary or PMA summary 
    provided the requested information has been documented in 
    writing and has the concurrence of, and has been initialed 
    by, a supervisor.  This documentation will become the basis 
    of the telephone call to the firm for the information or 
    changes and will become a part of the official file for the 
    submission.  After the telephone discussion, the firm may 
    then confirm the details of the conversation by telefax to 
    ODE, if it is desirable to do so to avoid any 
    misunderstandings because the request is complex, lengthy, or 
    may otherwise be subject to misinterpretation.  In this 
    latter case, the reviewer will acknowledge whether the 
    telefax is an accurate reflection of the information being 
    requested and the telefax will become part of the 
    administrative file for that submission.  When the firm fully 
    understands the request, the requested information must be 
    submitted in writing and processed through the Document Mail 
    Center as required by Blue Book Memorandum #I90-3.  The 
    effect, upon the official review clock, of making a telephone 
    request for additional information that requires a written 
    response depends upon the type of submission under review and 
    the nature of the deficiencies cited.  This is covered in 
    detail in Blue Book Memorandum #I91-1, "Document Review 
    Processing".

    ODE staff members must request additional data and 
    information in writing when the deficiencies are complex or 
    require the submission of substantial new information such as 
    a request that would require new clinical studies or new 
    analyses of data and information.  These written requests 
    will be made pursuant to ODE's normal operating procedures.  
    When desirable and after supervisory review, the information 
    requested in an issued letter may be discussed with the firm 
    either over the telephone or at a meeting.  This can help in 
    the clarification of the request for substantial new 
    information and in understanding the context of the request.  
    This data and information must be submitted in writing by the 
    manufacturer and processed through the Document Mail Center 
    as required by Blue Book Memorandum #I90-3.  The effect of 
    issuing written requests for additional data and information 
    upon the official review clock depends upon the type of 
    submission under review and the nature of the deficiencies 
    cited.  This is covered in detail in Blue Book Memorandum 
    #I91-1, "Document Review Processing".

    Each division may provide further guidance to its staff, 
    consistent with this memorandum, on the type of clarification 
    that may be requested or obtained via telephone versus the 
    type of data and information that must be requested and 
    submitted in writing.

2.  ODE staff members may accept calls from manufacturers to 
discuss the status of pending submissions after specified time 
periods in the review process have transpired, as set forth 
below.  ODE staff members may not accept, at any time, calls from 
third parties, such as financial analysts, stock brokers, 
reporters, etc., concerning the status of submissions under 
review.
 
    ODE staff members may not accept calls from manufacturers 
    concerning the status of a pending submission if the 
    submission is:
 
         - an IDE that has been in ODE less than 30 days;

         - a 510(k) that has been in ODE less than 90 days;

         - an unfiled PMA that has been in ODE less than 45 days; 
           or,

         - a PMA or PMA supplement that has been in ODE less than 
           180 days.

    After the foregoing time periods have transpired, ODE staff 
    members should exercise judgment regarding the 
    appropriateness of responding to status inquiries from 
    manufacturers.  The ODE staff should do its utmost to be as 
    responsive to the various publics and industry with which we 
    deal without sacrificing valuable time and resources.  For 
    example, it would not seem appropriate to entertain 
    repetitive inquiries concerning the status of pending 
    submissions.

    [Note:  As an alternative to the receipt of telephone calls 
    from manufacturers concerning the status of pending 
    applications as set forth above, ODE is initiating, within 
    the Center for Devices and Radiological Health (CDRH), a 
    proactive communication system regarding the status of 
    premarket approval applications, PMA supplements, and 510(k)s 
    at selected "milestones" in the PMA/510(k) review processes.  
    This system will be planned and developed over the next 
    several months by an inter-office task force within CDRH.  
    Consideration will be given to employing modern electronic 
    communications technology such as voice mail, MCI E-mail, or 
    other new developments suited to the purpose of keeping 
    manufacturers updated on the status of their submissions.  
    Furthermore, FDA is considering proposals that would specify 
    the format, content, and timing of public status reports 
    concerning submissions pending before the agency.  These 
    reports may include premarket approval applications, 510(k)s, 
    as well as other pending agency actions.  If the agency 
    ultimately adopts policies or procedures respecting the 
    public disclosure of the status of pending actions, ODE will 
    follow such policies and procedures and this memorandum may 
    be revised.]

3.  ODE staff members may accept calls from manufacturers 
concerning a pending submission if the call from the manufacturer 
is in response to a telephone call or letter from ODE about the 
submission.  Any manufacturer who abuses the use of the telephone 
by attempting to get frequent status information about a 
submission or by trying to improperly influence the timing or 
outcome of a review should be reported through supervisory 
channels.  If this type of abuse occurs repeatedly, that 
manufacturer's telephone access to ODE staff members may be 
curtailed. 

               B.  Other Business Telephone Calls

4.  ODE staff members may accept calls from manufacturers 
concerning business other than a pending submission under review.

    A manufacturer may initiate a call to an ODE staff member 
    concerning business matters other than a specific submission 
    under review, e.g., to discuss a scientific issue about a 
    draft voluntary standard.  When a manufacturer calls an ODE 
    supervisor or manager, the person answering the call will 
    notify the supervisor or manager who will return these calls 
    as soon as possible.  If a manufacturer calls a reviewer, the 
    person answering the call will automatically take a message 
    for the reviewer who will determine whether to return the
    call in accordance with this policy memorandum.

    Unless there is a need to discuss specific, official ODE 
    business, there is no requirement upon the part of any ODE 
    staff member to accept or return a call from a manufacturer.  
    This practice is necessary because of the heavy workload the 
    ODE staff is experiencing.  It is also consistent with other 
    FDA policies designed to avoid the kind of circumstances that 
    arose within the generic drug program.

5.  Telephone calls to ODE concerning the integrity or 
reliability of data in submissions made to ODE should be directed 
to the ODE Integrity Officer.

    Such telephone calls might be made by an anonymous caller or 
    the caller might identify himself or herself.  Also, the call 
    might relate to a pending or completed submission.  All such 
    calls should be referred to the ODE Integrity Officer.  

                     C.  General Procedures

6.  A written record of telephone conversations with 
manufacturers should be made if important for future reference.

    ODE staff members should make a written record of telephone 
    conversations with manufacturers or trade association 
    representatives, regardless of who initiated the call.  If 
    the purpose of the conversation was to obtain clarification 
    on a specific submission, it is sufficient to make a record 
    of the call along with notations on the submission itself 
    adjacent to the matter being clarified, unless the 
    clarification requires extensive comments.  In the latter 
    case, a separate note should be included in the file.  For 
    all other telephone conversations, staff are advised to keep 
    a log of the telephone contacts that may be important in the 
    future.

    In such cases, the record of a telephone conversation, 
    whether it be notations on the submission or a separate 
    memorandum, should include the date, the name and title of 
    the manufacturer's representative, the purpose and substance 
    of the call, the outcome of the conversation, and the name 
    and signature of the ODE staff member.

7.  Manufacturers must identify themselves and the reason for the 
call.

    All manufacturers calling an ODE staff member must be 
    prepared to state their name, title, and the reason for their 
    call, e.g., returning the call of a reviewer about 510(k) 
    #K691005, calling to discuss a scientific issue about a draft 
    voluntary standard or calling for clarification of a 
    deficiency letter that requests further information.

      D.  Effect on Prior Policies and Guidance Memorandum

8.  This guidance memorandum will have the following effect on 
prior Blue Book Memos.

    #A86-1 (10/16/86) "Guidance on Media Contacts"

Memorandum #A86-1 is unaffected in so far as the media contact 
does not contravene the policy and procedures set forth in this 
memorandum.  Record-keeping required under this guidance, in 
addition to the reporting required under #A86-1, applies to 
telephone contacts with members of the media.
 
    #P86-2 (01/31/86) "PMA Progress Reports to Applicants"

Memorandum #P86-2 is hereby rescinded and no longer in effect.

    #K89-2 (06/08/89) "Telephone Notification ... at 75 Days
    or Greater" 

Memorandum #K89-2 is hereby rescinded and no longer in effect. 
 
    #I89-3 (11/20/89) "Meetings With Industry"

Memorandum #I89-3 is unaffected by this guidance because #I89-3 
deals only with face-to-face meetings with industry.  That 
guidance recognized that an additional memorandum would be issued 
to deal with telephone calls with industry, which is the purpose 
of this guidance.

    #I90-3 (09/26/90) "Document Control Procedures"

Memorandum #I90-3 is unaffected.  The coverage of "Information 
Received Via Telephone" as covered in that memorandum is not 
inconsistent with the requirements of this guidance.

    #I91-1 (02/21/92) "Document Review Processing"

Memorandum #I91-1 is unaffected.  The statements concerning the 
use of the telephone to obtain clarification provided for in that 
guidance memorandum are not inconsistent with the requirements of 
this guidance.
This guidance memorandum supersedes and hereby rescinds the 
interim policy established by ODE on October 21, 1992 entitled 
"Telephone Contact with Industry".

Effective Date

This guidance is effective immediately.


                             David L. West, Ph.D