GHTF Study Group 2 Report

The purpose of this presentation is to update the GHTF general membership on the activities of Study Group 2 since the last GHTF Conference. Five documents will be discussed:

1. N36: Medical Devices; Post-market Surveillance: Manufacturer's Trend Reporting of Adverse Events
This document provides guidance on the use of trending of adverse events to make a determination about when it becomes necessary for a manufacturer to report to a National Competent Authority (NCA). This document has reached consensus within SG2 and is ready to be taken forward for public comment.

2. N20: Medical Devices; Post-market Surveillance: Competent Authority Reporting Criteria and Guidance
This document provides guidance and methodology for the exchange of vigilance reports between NCAs. This document has also reached consensus within SG2 and is ready to be taken forward for public comment.

3. N32: Medical Devices; Post-market Surveillance: Universal Dataset for Manufacturers
This document defines a dataset to meet the needs of every NCA to whom a manufacturer must submit an adverse event report. We have consensus on content; what remains is consensus on format. This is anticipated during the SG2 meeting in Ottawa. If achieved, this document will be ready to move forward for public comment. Otherwise, it is anticipated that revisions will be non-substantive, and a final draft document will be ready for public comment in the near future.

4. N30: Medical Devices; Post-Market Surveillance: Common and Well-Characterized Adverse Events
This document provides information, and does not constitute guidance. Information in this document is intended to inform NCAs about reporting alternatives for those post-market adverse events that are well known to both NCAs and industry, and are well documented in the medical, scientific, or technical literature. While both Australia and the United Kingdom have invoked reporting alternatives in response to specific investigations, currently only the USA has reporting alternatives incorporated into its regulations. Through the sharing of the information in this document, SG2 hopes to facilitate globally consistent alternatives to individual reporting requirements.

5. N21: Medical Devices; Post-market Surveillance: Adverse Event Reporting Guidance for the Manufacturer or its Authorized Representative
This document provides guidance to manufacturers about what does and does not need to be reported to the NCAs. Finalized during the GHTF Plenary Session in June 1999, Dr. Kessler will provide a status report on the progress of implementation of this document into the regulatory processes in the SG2 participating countries- Australia, Canada, Japan, the United States, and the European Union.

He has published over eighty peer-reviewed journal articles, as well as numerous book chapters and government reports. His research has concentrated on applications of quantitative methods and health services research to problems in surveillance and public health. Dr. Kessler received his Doctor of Science (Sc.D.) from the Johns Hopkins University, School of Hygiene and Public Health in 1978.

None.
Note: The two documents N36: Medical Devices; Post-market Surveillance: Manufacturer's Trend Reporting of Adverse Events, and N20: Medical Devices; Post-market Surveillance: Competent Authority Reporting Criteria and Guidance, which are awaiting advancement to Proposed Document status, will be posted on the GHTF website as soon as the decision has been made.