[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public meeting to discuss the draft guidance entitled ``Medical Device 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