CDRH guidance details alternative summary reporting of adverse events
Reprinted from the Guide to Good Clinical Practice, ©Thompson Publishing Group
In keeping with efforts to streamline the medical device adverse event reporting process, the Center for Devices and Radiological Health (CDRH) issued guidance on Oct. 19 detailing procedures for its alternative summary reporting (ASR) program, which exempts certain types of devices with well-known problems from individual adverse event reporting requirements. The FDA initiated the program after determining that the submission of periodic summary reports for recurrent adverse events related to certain devices would still allow for effective monitoring and evaluation.
The benefits of the ASR program are twofold, Larry Kessler, director of CDRH's Office of Surveillance and Biometrics, said. First, the program minimizes paperwork and reduces costs for both CDRH and participating manufacturers. Second, ASR affords manufacturers more time to follow up on adverse events.
In fact, Kessler observed, in the three years since the FDA first established instructions and conditions for summary reporting of adverse events in a July 1997 memorandum to manufacturers, the number of individual event reports submitted to the FDA has been reduced by half. In turn, this reduction has enabled analysts to examine individual events on a case-by-case basis, according to Kessler.
Reporting procedures
The guidance, which supersedes the agency's 1997 memo, outlines new methods for requesting approval to participate in the ASR program and for preparing ASR reports.
The main difference between the new guidance and the memo it replaces centers around data collection methods. Under the new guidance, adverse events included in summary reports must be submitted to the agency in a line-item format. This format, which was first introduced by the FDA in October 1999, entails reporting selected data elements by individual adverse event, rather than by grouping adverse events by device identification number. The line-item format prevents manufacturers reporting on several devices from having to list the same adverse event data more than once.
The guidance outlines several conditions for participating in the ASR program. ASR reports are to be submitted to the FDA on a quarterly basis but must be preceded by baseline adverse event reports, the guidance states. Baseline reports are considered critical to the ASR program because they provide the FDA with a sense of an adverse event's scope and allow for the identification of trends; therefore, they must be accurate and timely, the guidance states. ASR approval letters will contain printouts of baseline reporting data, which manufacturers must correct or update, according to the guidance.
Although the guidance offers a different event reporting structure, manufacturers still are required to investigate and evaluate complaints and to establish and maintain medical device reporting event files. Further, the FDA retains the right to revoke or modify ASR exemptions or to request individual event reports to assist in the evaluation of a specific event.
Although the ASR program is fairly inclusive, the guidance lists eight specific types of events that are not covered by the program. For example, events requiring the submission of a five-day report, events where the device may have caused or contributed to death and events that the manufacturer considers unusual, unique or uncommon are ineligible for ASR reporting.
Requests for participation
To participate in the ASR program, manufacturers must submit a written request to the FDA explaining why the request is justified; identifying the device manufacturer and the product classification code(s) for the device(s) that will be included in the ASR report; and listing the reporting site registration number, contact person and address of the firm submitting the report.
Outlook
Under the guidance's new methodology, the FDA expects that the adverse event reporting process will become increasingly fluid, and manufacturer participation will increase. Several devices have been added to an initial list of 12 specific device types qualifying for the ASR program, which the FDA released in July 1997. The agency expects to post an updated list on their Web site (http://www.fda.gov) by the end of the year.
For the complete text of the ASR guidance, go to http://www.fda.gov/cdrh/osb/guidance/315.html.
This article was originally published in the Guide to Good Clinical Practice by Thompson Publishing Group. For more information, visit the Thompson Publishing Group's storefront on Medical Design Online.