Medical Devices

Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3) (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.

    August 9, 1996
    Director, Office of Device Evaluation (HFZ-400) 
    Interim Director, Office of Health Industry Programs (HFZ-230) 
    Memorandum of Understanding Regarding Patient Labeling Review 
    Office of Device Evaluation Review Staff 
    Office of Health Industry Programs, Division of Device User Programs 
    and Systems Analysis 
    The purpose of this guidance memorandum is to make available to Office 
    of Device Evaluation (ODE) reviewers and Division of Device User 
    Programs and Systems Analysis (DDUPSA) reviewers within the Office of 
    Health Industry Programs (OHIP), an interoffice agreement regarding the 
    evaluation of premarket approval (PMA) patient labeling.  This 
    memorandum outlines each office's responsibility for the PMA.  

    ODE has the lead responsibility for review and approval of PMA 
    applications.  OHIP has the lead responsibility for User programs.  A 
    program in OHIP/DDUPSA encourages the application of human factors 
    principles to the design of medical devices and labeling in order to 
    enhance their safety and effectiveness during use.  As part of the 
    Center for Devices and Radiological Health (CDRH) initiative to assure 
    adequate patient labeling, DDUPSA's role is being expanded to include 
    routine review of patient labeling for all original PMAs and 
    panel-track supplements.  
    Patient labeling has two main purposes.  One is to help counsel 
    patients on the risks and benefits associated with the use of a device, 
    explaining why the device is being used in their diagnosis or 
    treatment.  The other is to guide patients or lay users when they are 
    expected to operate or use the device.  DDUPSA will evaluate the 
    usability of both kinds of patient labeling.  If an applicant does not 
    submit patient labeling, DDUPSA will assess the need for it and discuss 

    with ODE that need.  When DDUPSA evaluates patient labeling that is 
    intended to guide patients or lay users when they operate or use the 
    device, DDUPSA will examine and evaluate, as resources permit, the 
    usability of a sample of the device (if available), and assure that it 
    operates consistently with the instructions for use.  Usability is the 
    capability of a device and its labeling to be used safely and 
    It is important for all ODE and DDUPSA managers and reviewers to 
    understand the importance and effect the patient labeling review  will 
    have on the PMA process.  It is for these reasons that we are 
    requesting that you take a few moments to familiarize yourself with the 
    content of this agreement.
    Should a patient labeling consult be required for submissions not 
    specifically identified in this memorandum, (for original PMAs and 
    panel track supplements currently under review or received prior to the 
    effective date, PMA supplements other than panel-track supplements, 
    510(k)s or IDEs), the ODE reviewing Division will have the 
    responsibility of initiating contact with the Division Director, DDUPSA 
    in the form of a written request or via an electronic mail message.  
    Attached is a list of the specific procedures and events in the 
    agreement.  In addition, a time line of events and a description of 
    activities for a specific PMA versus events that will occur for any PMA 
    or panel-track supplement to further clarify this policy is provided.  
    This time line assumes that the PMA was received on January 1, 1996. 
    If you have questions regarding any aspect of the interoffice agreement 
    or how the agreement will impact upon the applications in your 
    division, please see your division's PMA contact person in POS.  Any 
    questions from the regulated industry regarding the patient labeling 
    review, other than ODE procedures and responsibilities, should be 
    referred to the DDUPSA team member as described in the memorandum. 
    Effective Date 
    This policy is effective immediately.  There will be an assessment of 
    the effectiveness of this agreement in 6 months. 

    _____________________________       ____________________________  
    Susan Alpert, PhD., MD              Joseph A. Levitt 
    Director                                         Interim Director 
    Office of Device Evaluation         Office of Health and Industry  Programs 

                                        General Program Memorandum - #G96-3
                                                      Attachment A - Page 1
    Memorandum of Understanding Regarding Patient Labeling Review - 
    Specific Events 


    1)   The PMA section within the Program Operations Staff (POS) within 
         ODE will notify DDUPSA staff within OHIP, via a memorandum, upon 
         receipt of an original PMA application or a panel-track 
         A copy of the PMA volume 1 and any other labeling volumes will be 
         provided to DDUPSA by the DMC within 3 days of receipt of the 
         application by the ODE Document Mail Center (DMC).  Should the PMA 
         not require patient labeling, DDUPSA will notify the PMA section 
         and reviewing ODE division in a memorandum within 20 days from the 
         receipt of the PMA.  
    2)   When patient labeling is present in the PMA, the DDUPSA Division 
         Director will designate a review team member within 7 days of 
         receipt of the PMA.  Further, DDUPSA will identify to the ODE 
         Division, within 8 days of receipt of the PMA, a DDUPSA review 
         team member to serve as the point of contact for the PMA 
         application.  The same applies when upon evaluation ODE/DDUPSA 
         believes that patient labeling should be developed.  DDUPSA will 
         send a memorandum to the PMA section and the ODE Division which 
         will describe the need for, and/or presence of, patient labeling.  
         ODE will track via the PMA database whether a patient labeling 
         review will be performed by DDUPSA.  The memorandum should be 
         provided to ODE within 20 days from the date of receipt of the PMA 
         so that the DDUPSA review team member may be notified of the 
         filing meeting, should one be scheduled. 
    3)   If a filing meeting takes place, it should occur around day 30 to 
         meet the 45 day filing decision required by the current PMA 
         regulation.  This filing meeting will include all review team 
         members to discuss issues raised during their individual 
         evaluations of the PMA for filing and to determine which decision 
         is appropriate, i.e. to file or not file the application. 
    4)   ODE and DDUPSA will jointly evaluate as part of the PMA Checklist 
         for Filing Decisions whether patient labeling is necessary.  The 
         ODE Division will communicate through the filing/or not filing 
         letter to the applicant, any need for patient labeling if it was 
         not initially submitted.  The letter will also identify the need 
         for an operational sample (or samples, if a single-use device) of 
         the device for DDUPSA to use in its usability evaluation, when 
    5)   Should patient labeling be present or deemed necessary, ODE will 
         keep the DDUPSA team member informed regarding all team meetings 
         so that they can attend as appropriate.  
    6)   DDUPSA will be included on the distribution list for all  PMA 
         boilerplate letters related to originals and panel-track 
         supplements unless DDUPSA has indicated via a memorandum that 
         patient labeling is not required for that device type.  DDUPSA 
         will be provided a copy of the letters that have issued to the PMA 
         applicant within 3 days of issuance when a labeling review has 
         been designated as necessary.  
    7)   The ODE reviewing division will work with DDUPSA team member to 
         ensure that all of the pertinent sections of the PMA are available 
         for their review including subsequent amendments to the 
         application pertaining to labeling.  Any additional volumes needed 
         by DDUPSA will be provided by DMC personnel at the request of the 
         reviewing division.  The ODE reviewing division also has the 
         responsibility of keeping DDUPSA informed of changes in the 
         labeling and changes in the design that the applicant has 
         submitted which may impact on the usability of the patient 
     8)  DDUPSA will be responsible for providing their written evaluation 
         of the patient labeling to the ODE reviewing division.  These 
         comments will evaluate labeling (patient counseling information), 
         usability of the devices and their instructions for use when the 
         user is a lay user or patient and appropriateness of the  
         applicant's usability studies.  
    9)   When appropriate DDUPSA and ODE Team Leaders will consult directly 
         with applicants during device development on the usability of 
         labeling or the device.  DDUPSA will prepare documentation of 
         telephone contact with the applicant.  DDUPSA in coordination with 
         the PMA lead reviewer will ensure that the final negotiated label 
         is submitted in the form of an amendment to the application by the applicant via the DMC. 
    10)  ODE Division will have the responsibility of providing DDUPSA with 
         written assessment or discussion of the recommendations by DDUPSA.  
         The ODE lead reviewer should ensure that prior to issuing a 
         deficiency letter to the applicant, that the DDUPSA team member 
         has an opportunity to review the draft letter. 
    11)  Close and continual communication between the reviewing division 
         and DDUPSA team member must exist to ensure that the patient 
         labeling is consistent with other labeling. 
    12)  The PMA section will send to DDUPSA a copy of the final printed 
         labeling for the marketed device within 3 days of receipt, so that 
         DDUPSA can assure that the final printed label contains the same 
         language as the final draft label which was the basis for the PMA 
         approval decision.  A brief written review by DDUPSA must be 
         provided to the ODE Division which either identifies the 
         differences and recommendations regarding their significance or a 
         brief statement that the final printed label is consistent with 
         the final draft label.  This review should be provided within 30 
         days of receipt of the final printed labeling amendment.

Attachment B is a graph.

Graph of Patient Labeling Review Process - Specific Events

                          THE END


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