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The Center for Devices and Radiological Health (CDRH) FDA held
an open public meeting on September 5, 1997, to provide a forum
for discussion of issues related to medical device labeling.
The purpose was to discuss reactions to the recently published
draft guidance document "Medical Device Labeling - Suggested
Format and Content" and to identify issues that manufacturers,
users and others have with medical device labeling, the labeling
regulation (21 CFR 801) or labeling procedures used by CDRH. The
meeting was announced in the August 1, 1997 Federal Register with
twelve questions intended to trigger discussion.
The agency is concerned that currently used device labeling may
not meet well the needs of the health care professionals who must
select and use these products for patient diagnosis and care.
A study of health care professional use of and preferences in
device labeling was conducted by CDRH. The study was meant to
augment previous labeling studies by the agency and information
gained from other sources and to guide the Center in recommending
labeling improvements. The study results are reported in the
document entitled, "Draft Initial Report on Medical Device
Labeling: Health Care Practitioners' Medical Device Information
and Labeling Needs-Results of Qualitative Research".
In response to our assessment of practitioner, Center and industry
needs and based on the CDRH labeling guidance in current use,
General Program Memorandum #G91-1, as well as information learned
in this study, the Center developed a draft guidance document
entitled "Medical Device Labeling-Suggested Format and Content".
The draft guidance is intended to assist device manufacturers
in designing labeling and FDA in evaluating labeling. It seeks
to promote clarity and uniformity in medical device labeling and
suggests a standard format and content.
At the September 5 meeting, a discussion group of twelve representatives
from CDRH, industry, the fields of human factors and risk communication,
and the medical device user community was convened. They presented
and discussed concerns with the way device information is currently
conveyed in labeling, the new labeling recommendations in the
draft guidance document, user needs from device labeling, and
obstacles to meeting these needs. There were also presentations
and discussion from the meeting attendees. A docket was provided
for those unable to attend or who wished to provide further comment
after the meeting.
Dr. Burlington, Director of CDRH and a practicing physician, began the discussion by pointing out that collectively we are doing a sub-optimal job of communicating through labeling what users need to know about medical devices. He pointed to three principle uses for device labeling:
There was agreement from those in attendance that we need to communicate
more effectively with device users through labeling. Some sources
of difficulty in satisfying the varied uses of labeling were identified
as: the diversity of medical devices, differing user needs at
different points in the selection and use process, users with
varied technical expertise, and harmonization issues (such as
language consistency to facilitate translations, the acceptance
and use of symbols, and the avoidance of formatting models that
may have varied interpretations in different countries). The
challenge is to determine what "modules" of labeling
information, in what form and with what content, make up the whole
labeling of a device and how those modules should be disseminated
to make sure that all users' needs are met. Part of this task
is deciding what information is "significant" to what
user and in what circumstance, and therefore to what module, and
determining who will make this decision.
Clinical experts supported Dr. Burlington's contention that the
current approach is not meeting their needs. Labeling is difficult
for practitioners to locate when they need it. When they do get
their hands on it, they have trouble finding necessary information
quickly. There may be approaches to labeling that can alleviate
some of the concerns. The clinicians expressed interest in labeling
with a consistent format and content and some approach to highlighting
critical decision making information. The human factors and risk
communication experts in the discussion group pointed out that
it has been shown that consistency aids information extraction
and that brief, graphic presentations are more likely to be read.
However, they stressed that labeling should be tested with intended
users to assure comprehension.
Industry representatives agreed that a consistent format, specific headings in a specific order, would make sense. A number of firms are already doing it across their product lines. Industry has considerable concern with the content suggestions, however, and with the concept of a highlights document. They believe that following the recommendations in the draft labeling guidance may increase the amount of labeling and, thus, costs. There was also considerable concern about increased US requirements at the time when the European Medical Device Directives are about to go into effect. They suggested that investigation be conducted into what works for what devices, believing that one size does not fit all. In addition, distribution, how to get the necessary information into the hands of the user, remains an important issue that calls for a systems approach to solutions. Pilot studies were suggested as an approach to investigating a number of the issues.
There was broad support for periodic, tabular, summary reporting
of clinically foreseeable events that are listed in the Adverse
Events section of the labeling, as presented by Dr. Kessler, Director
of the Office of Surveillance and Biometrics.
Dr. Alpert summarized the day's discussion, pointing out that
questions remain of specifically what information to provide,
to whom and for what devices, and who should be the judge of this.
Suggestions from participants for proceeding from here included
developing specific product area guidance and conducting pilot
studies. The agency will consider input from the meeting and
the open docket in determining the next steps and will continue
to engage the industry and user community in the process.
For further information, contact Patricia Kingsley, Center for Devices and
Radiological Health (HFZ 230), Food and Drug Administration, 1350 Piccard Drive,
Rockville, MD 20850 [301-443-2436], pak@cdrh.fda.gov.
(This page last updated October 23, 1997)
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