[Federal Register Volume 62, Number 148 (Friday, August 1, 1997)]
[Notices]
[Pages 41398-41400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0312]
Medical Devices; Device Labeling Requirements; Notice of Public
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an open
public meeting to discuss the draft guidance entitled ``Medical Device
Labeling--Suggested Format and Content,'' which is being announced
elsewhere in the issue of the Federal Register, and to identify other
concerns that manufacturers and others may have regarding the medical
device labeling regulation or the labeling procedures used by the
Center for Devices and Radiological Health (CDRH). Revision of the
labeling requirements for in vitro diagnostic products is not being
considered at this time. Health care practitioners and lay users of
medical devices are encouraged to participate in the public meeting.
DATES: The public meeting will be held on September 5, 1997, from 9
a.m. to 5 p.m. Written notices of participation should be filed by
August 22, 1997. Submit written comments by September 24, 1997.
ADDRESSES: The public meeting will be held at the Double Tree Hotel,
1750 Rockville Pike, Rockville, MD 20852. Submit written notices of
participation and written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Patricia A. Kingsley, Center for
Devices and Radiological Health (HFZ-230), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-2436,
or via Internet at ``[email protected]''.
[[Page 41399]]
SUPPLEMENTARY INFORMATION:
I. Background
The labeling of most medical devices is regulated by part 801 (21
CFR part 801). Since the original Medical Device Amendments of 1976,
the agency has issued a number of guidance documents to assist
applicants in developing effective and informative medical device
labeling. These documents include the General Program Memorandum #G91-
1, entitled ``Device Labeling Guidance,'' as well as numerous device-
specific documents. Over time, the agency has received feedback that
manufacturers have some concerns with part 801 and other agency
procedures concerning device labeling. In addition, the agency has
heard from users of devices that medical device labeling is less useful
than it might be. These comments have encouraged the agency to
reevaluate its labeling regulations and guidance.
Concerns about the effectiveness of communication through labeling
of FDA regulated products extend beyond medical devices. Research on
label content and format preferences in the user community has been
conducted and a public hearing has been held by the Center for Drug
Evaluation and Research. The results of the research are available in
the transcript of the public hearing in Docket No. 95N-0314. CDRH
conducted research with health care practitioners to determine how they
use device labeling and what would make it more useful to them. The
report entitled ``Draft Initial Report on Medical Device Labeling:
Health Care Practitioners' Medical Device Information and Labeling
Needs--Results of Qualitative Research'' is available via the internet
on CDRH's homepage at ``http://www.fda.gov/cdrh/humfac/
hufacact.html#Draft Initial Report''. The results of the research were
used in the development of the draft guidance entitled ``Medical Device
Labeling--Suggested Format and Content,'' which was placed on the FDA
homepage in April 1997, and is being announced elsewhere in this issue
of the Federal Register.
The agency notes that labeling of in vitro diagnostic products are
regulated under 21 CFR 809.10 and are not subject to the draft
guidance, nor will they be the subject of discussion at the September
5, 1997, public meeting.
II. Medical Device Labeling Issues
FDA is soliciting comments on the notice of availability, which is
published elsewhere in this issue of the Federal Register. The draft
guidance which was previously posted on FDA's homepage also solicited
comments. The agency also wants to gather information on broader
regulatory and procedural issues regarding labeling that may be
important to manufacturers, users, and FDA. For that reason, the agency
is holding a public meeting to discuss issues raised by the suggestions
in the draft guidance, the present labeling regulation in part 801, and
any other concerns that manufacturers and the user community may have
with medical device labeling.
The agency is particularly interested in responses to the following
questions:
1. For which types of devices would labeling consistent with the
draft guidance be inappropriate? Why would it be inappropriate?
2. Should there be different labeling requirements for different
types of medical devices?
3. What are specific labeling requirements for over-the-counter
devices?
4. Are there other types of devices that should have labeling
format and content requirements that are different from those discussed
in the draft guidance?
5. The draft guidance recommended the development of a summary
document called the Essential Prescribing Information (EPI) label. Are
there any devices for which such a piece or section of labeling might
not be applicable? Why not?
6. What are the benefits to industry and/or the user community of
adopting the content and format discussed in the draft labeling
guidance?
7. What costs would be incurred by industry for adopting a
consistent format design and highlight information? What are the costs
of making the labeling change? What factors significantly affect
labeling costs? How frequently is device labeling revised? What
strategies can be used to lessen the cost to industry?
8. Should CDRH implement consistent format and content and the EPI
as requirements for medical device labeling?
9. Are there recommendations in the guidance that create new
impediments to developing labeling for the international marketplace?
Are there ways that CDRH could facilitate harmonization efforts in
device labeling? Should provisions be made for the use of symbols in
device labeling?
[[Page 41400]]
10. What methods are available to provide users with more access to
device labeling?
11. Are there other issues with the labeling regulation or the
labeling procedures used by CDRH that the agency should address?
12. Relating to FDA's medical device reporting system, what are the
concerns if the agency would require manufacturers to submit periodic
summary reports for common and anticipated adverse events that are
listed in the device labeling, in lieu of individual incident reports.
The agency's interest in requiring summary reporting for anticipated
adverse events already listed in the labeling is to improve the signals
received in the medical device reporting system and to reduce repeat
reports of known problems when further agency action is unlikely. What
adverse events should still be reported individually, even if the
events are anticipated and listed in the labeling?
Interested persons who wish to participate may, on or before August
22, 1997, submit notice of participation to the Dockets Management
Branch (address above). All notices of participation submitted should
be identified with the docket number found in brackets in the heading
of this document and should contain the name, address, telephone
number, business affiliation of the person requesting to make a
presentation, a brief summary of the presentation, and the approximate
time requested for the presentation.
Individuals or groups having similar interests are requested to
consolidate their comments and present them through a single
representative. FDA may require joint presentations by persons with
common interests. FDA will allocate the time available for the meeting
among the persons who properly file a notice of appearance.
Persons who are unable to participate on the day of the meeting are
encouraged to submit written comments to the Dockets Management Branch
(address above). Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
Dated: July 24, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20312 Filed 7-31-97; 8:45 am]
BILLING CODE 4160-01-F
