[Federal Register Volume 64, Number 150 (Thursday, August 5, 1999)]
[Notices]
[Pages 42701-42702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20140]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N092075]
Global Harmonization Task Force; Draft Document on Proposal for
Reporting of Use Errors with Medical Devices; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a Global Harmonization Task Force (GHTF) draft document
entitled ``Proposal for Reporting of Use Errors with Medical Devices.''
The draft guidance includes information for regulatory authorities
about reporting of adverse events that result in death or serious
injury or certain types of near incidents. This draft document has been
prepared by members of the GHTF Study Group 2 (SG2) on Medical Devices
Vigilance/Postmarket Surveillance Reporting Systems. The draft document
represents a harmonized proposal. Elements of the approach set forth in
this draft document may not be consistent with current U.S. regulatory
requirements. FDA is requesting comments on this draft document.
DATES: Written comments by September 7, 1999. After the close of the
comment period, written comments may be submitted at any time to
Deborah Y. Blum (address below).
ADDRESSES: Submit written comments on the draft document to the Dockets
Management Branch (HFA09305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be
identified with the docket number found in brackets in the heading of
this document. If you do not have access to the World Wide Web (WWW),
submit a written request for a 3.5'' diskette of the draft document
entitled ``Proposal for Reporting of Use Errors with Medical Devices''
to the Division of Small Manufacturers Assistance (HFZ09220), Center
for Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your requests, or fax your
request to 30109443098818. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the draft document.
FOR FURTHER INFORMATION CONTACT: Deborah Y. Blum, Office of
Surveillance and Biometrics (HFZ09520), Center for Devices and
Radiological Health, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 30109594092985.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has participated in a number of activities to promote the
international harmonization of regulatory requirements, as described in
an FDA notice on these activities published in the Federal Register of
October 11, 1995 (60 FR 53078). As part of this effort, FDA has been
actively involved since 1992 with GHTF. GHTF has formed four study
groups, each tasked with assignments to draft documents and carry on
other activities, designed to facilitate global harmonization. The
purpose of this notice is to seek public comments on a draft document
that has been prepared by one of the GHTF study groups.
SG2 was formed by GHTF in February 1996 and tasked with the
responsibility to examine the requirements for the reporting of adverse
incidents involving medical devices; consider postmarket surveillance
and other forms of vigilance; and recommend ways of harmonizing these
requirements. SG2 was also requested to promote the dissemination of
relevant information concerning these matters. SG2 helps to improve
protection of the health and safety to patients, users, and others;
evaluate reports and disseminate information which may reduce the
likelihood of or prevent repetitions of adverse events, or alleviate
consequences of such repetitions; and define postmarket medical device
reporting and surveillance requirements and guidelines on an
international basis.
Reporting of adverse events involving medical devices is an
important element in any good postmarketing surveillance system and can
be achieved only through mutual confidence among all parties concerned.
The obligation to report adverse events differs widely among countries.
Some systems are voluntary, while others are mandatory. The common
thread that could tie all of the worldwide reporting systems together
is the obligation for manufacturers to report adverse events or
incidents of which they are aware that involve medical devices.
It is the premise of the work of GHTF SG2 that an international
system for reporting adverse events can be developed to handle
information provided by the manufacturer to the authorities.
FDA is announcing the availability of a draft document entitled
``Proposal for Reporting of Use Errors with Medical Devices.'' The GHTF
SG2 has developed a reference for manufacturers regarding adverse event
reporting. This draft document is referenced as SG2 N21R8 . It includes
information for regulatory authorities about reporting of adverse
events that result in death or serious injury or certain types of near
incidents. It includes the consideration that certain types of failures
may be exempt from reporting under regulatory vigilance procedures, but
does not include a specific proposal on reporting of use errors.
``Proposal for Reporting of Use Errors with Medical Devices'' gives an
overview on emerging process standards which are streamlining the
handling of use errors by industry and makes a proposal to regulatory
authorities on how to handle use errors under adverse event reporting
procedures.
II. Electronic Access
Persons interested in obtaining a copy of the draft document may
also do so using the WWW. CDRH maintains an entry on the WWW for easy
access to information including text, graphics, and files that may be
downloaded to a personal computer with access to the WWW. Updated on a
regular basis, the CDRH home page includes the the draft document
entitled ``Proposal for Reporting of Use Errors with Medical Devices,''
device safety alerts, Federal Register reprints, information on
premarket submissions (including lists of approved applications and
manufacturers' addresses), small manufacturers' assistance, information
on videoconferencing and electronic submissions, mammography matters,
and other device-oriented information. The CDRH home page may be
accessed at ``http://www.fda.gov/cdrh''.
III. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding this draft document. Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments should be identified with the docket number
found in brackets in the heading of this document. A copy of the draft
document and received comments are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
[[Page 42702]]
After September 7, 1999, written comments regarding the draft
document may be submitted at any time to the contact person (address
above).
Dated: July 20, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-20140 Filed 8-4-99; 8:45 am]
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