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DEVICE/DRUG/BIOLOGIC ADVERSE EVENT REPORTING FORM

This article was originally published in The Gray Sheet

Executive Summary

DEVICE/DRUG/BIOLOGIC ADVERSE EVENT REPORTING FORM will be released in conjunction with FDA's final medical device reporting regulations, the agency says in a Feb. 26 Federal Register notice describing a draft of the form. Although "the date that the final form will be available has not yet been set," FDA says its release will coincide "with publication of...final rules on medical device user facility, distributor, and manufacturer reporting." FDA's Center for Devices and Radiological Health is in the process of finalizing regulations that would implement the user and distributor reporting requirements of the Safe Medical Devices Act of 1990 and modify existing manufacturer reporting requirements. CDRH had been developing a device-specific form in conjunction with drafting of the reg; however, that effort was suspended when the agency decided to develop the single form for reports on devices, drugs and biologics ("The Gray Sheet" Jan. 4, p. 2). FDA says it will "phase out" existing forms "within 180 days from the issuance of a final form based on this draft." A final form is not likely to be published before the fall of this year, when device reporting regulations are expected to be finalized. FDA says that the "simplified and consolidated reporting form will improve reporting of suspected serious adverse events and product problems" and "thereby enhance the detection and reduction of drug-, biologic-, and device-induced disease and injuries." The agency says it also expects the single form to "enhance agency- wide consistency in the collection of postmarketing data." FDA stresses that the identity of health professionals reporting adverse incidents directly to the agency will not be released "to the manufacturer if the reporter requests that this information not be provided." The agency notes that users "will be asked to indicate on the [reporting] form if they do not want their identity disclosed to the manufacturer." FDA adds, however, that "by allowing the agency to share the reporter's identity with the manufacturer, health professionals will facilitate efforts by FDA and the manufacturer to conduct necessary and rapid followup in selected cases." In a December letter to FDA, the Health Industry Manufacturers Association expressed concern over a reporting system that would encourage users to bypass manufacturers and report "solely to FDA." HIMA also suggested that the report form "encourage return of devices to the manufacturer." This issue is not addressed in the Federal Register notice. FDA proposes establishment of a single agency location for receipt of voluntary user reports related to devices, drugs and biologics. "Health professionals submitting voluntary reports will be able to submit this form by mail or by toll-free fax to a central receipt point at FDA." The agency adds that "manufacturers, user facilities and distributors will send their reports to the addresses specified in the appropriate regulations." The agency adds that it is "examining ways to permit electronic submission of reports by manufacturers" and "encourages suggestions for facilitating electronic submission." The device center plans to hold a workshop with industry later this year to discuss ideas for an electronic reporting system, according to FDAers.
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