[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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The draft guidance includes information for regulatory authorities 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]
BILLING CODE 4160-01-F