Reports and guidance documents; availability, etc.: Global Harmonization Task Force; adverse event and vigilance reporting of medical device events,

[Federal Register: August 31, 1998 (Volume 63, Number 168)]

[Notices]

[Page 46227-46228]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr31au98-63]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0646]

Global Harmonization Task Force: Draft Documents on Adverse Event and Vigilance Reporting of Medical Device Events; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of five draft documents entitled ``Comparison of Device Adverse Report Systems'' (SG2-N6), ``Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices'' (SG2-N8), ``Global Medical Devices Vigilance Report (Form and Instructions)'' (SG2-N9), ``Pre' cis'' (Vigilance and Postmarket Surveillance) (SG2-N12), and ``Adverse Event Reporting Guidelines for Manufacturers'' (SG-N21). These documents have been prepared by members of the Global Harmonization Task Force (GHTF), study group 2 on Medical Devices Vigilance/Postmarket Surveillance Reporting Systems. The documents are intended to provide information only and represent a harmonized group of proposals. Elements of the approach set forth in these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents.

DATES: Written comments by September 30, 1998. After the close of the comment period, written comments may be submitted at any time to Larry G. Kessler (address below).

ADDRESSES: Submit written comments on the draft documents to the Dockets Management Branch (HFA-305), 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 written requests for single copies on a 3.5'' diskette of the draft documents entitled ``Draft Documents on Adverse Event and Vigilance Reporting of Medical Device

[[Page 46228]]

Events'' to the Division of Small Manufacturers Assistance (HFZ-220), 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 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to these draft documents.

FOR FURTHER INFORMATION CONTACT: Larry G. Kessler, Office of Surveillance and Biometrics (HFZ-500), Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2812.

SUPPLEMENTARY INFORMATION:

1. 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 draft documents that have been prepared by one of the GHTF study groups.

   Study group 2 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. Study group 2 was also requested to promote the dissemination of relevant information concerning these matters. Study group 2 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 the manufacturer to report adverse events or incidents of which they are aware that involve medical devices.

   It is the premise of the work of GHTF study group 2 that an international system for reporting adverse events can be developed to handle information provided by the manufacturer to the authorities.

   1. In the draft document entitled ``Comparison of the Device Adverse Report Systems'' (SG2-N6), study group 2 compares 11 aspects of the regulatory systems of each of these countries with respect to the purpose of the device adverse event report systems, applicability, report timing, reporting criteria, not reportable incidents/events, procedures to report, applicable forms, content of the forms, role of the authority, definitions, and responsible entity for the investigation of the adverse event.

   2. In the draft document entitled ``Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices'' (SG2-N8), information and guidance is provided that represents a harmonized proposal. This document contains information on communication between National Competent Authorities on events related to medical devices; when and how to inform publicly about adverse events; concerns with releasing information nationally; a list of criteria on how to disseminate information on adverse events, nationally; and recommendations on when an authority decides to disseminate information to the public.

   3. In the draft document entitled ``Global Medical Devices Vigilance Report (Form and Instructions)'' (SG2-N9), information and guidance is provided about relevant measurers and/or recommendations relating to the prevention of adverse incidents concerning medical devices.

   4. In the draft document entitled ``Pre'cis'' (SG2-N12R6), an overview and focus is provided of the mission, scope, and activities of the GHTF-SG-2.

   5. In the draft document entitled ``Adverse Event Reporting Guideline for Decisions for Manufacturers'' (SG2-N21), a ``Decision Tree'' matrix is presented for manufacturers and their representatives to decide when an adverse event should be reported.

   It should be noted that these GHTF draft documents represent the current thinking and directions for harmonized postmarket surveillance, adverse event, and vigilance reporting aspects worldwide. These draft documents are presented for review and comment so that industry and other members of the public may express their views regarding global harmonization of medical device adverse event reporting.

2. Electronic Access

   Persons interested in obtaining a copy of these draft documents may also do so using the WWW. CDRH maintains an entry on the WWW for easy access to the Web. Updated on a regular basis, the CDRH Home Page includes ``Draft Documents on Adverse Event and Vigilance Reporting of Medical Device Events,'' device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video-oriented conferencing and electronic submissions, mammography matters, and other device oriented information. The CDRH home page may be accessed at http:// www.fda.gov/cdrh.

3. Comments

   Interested persons may on or before September 30, 1998, submit to the Dockets Management Branch (address above) written comments regarding the draft documents. 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 and with the full title of these documents. The draft documents and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

   After September 30, 1998, written comments regarding the draft documents may be submitted at any time to the contact person (address above).

   Dated: August 19, 1998. D.B. Burlington, Director, Center for Devices and Radiological Health.

   [FR Doc. 98-23271Filed8-28-98; 8:45 am]

   BILLING CODE 4160-01-F