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 Purpose 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. Background 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 effectively. 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 supplement. 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 appropriate. 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 labeling. 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.