Medical Devices
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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
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.
THE END
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