FDA DEVICE/DRUG/BIOLOGICS ADVERSE INCIDENT REPORTING FORM

FDA DEVICE/DRUG/BIOLOGICS ADVERSE INCIDENT REPORTING FORM will be used by device manufacturers, distributors and user facilities to report device-related adverse incidents. The FDA commissioner's office has set up a task force to develop an adverse incident reporting form that would be used for devices, drugs and biologics. FDAers say that the creation of the form will obviate the need for the Center for Devices and Radiological Health to finalize device-specific forms. The forms have been under development as part of CDRH's effort to implement device user/distributor reporting requirements and modify the existing manufacturer reporting program. The generic document is expected to incorporate elements of the forms that CDRH has been working on. Development of a single form in coordination with CDRH would alleviate one concern raised by the Health Industry Manufacturers Association in a Dec. 23 letter to FDA. The letter, which follows up on a Dec. 4 industry/agency meeting, says that the agency should "avoid the troubling situation in which FDA could establish one set of forms in its final rule on manufacturer, user and distributor reporting but move a short time later to require the form that your special group develops." The single report form for all industries is intended to promote reporting of adverse events, particularly voluntary reporting by individual health care professionals, by simplifying and clarifying the reporting process. However, HIMA believes that use of a common form could discourage voluntary reporting to manufacturers. "We...have concerns about any reportable events system, including specific forms, that would encourage health professionals to bypass reporting these events to manufacturers in favor of reporting solely to FDA," HIMA says. "Manufacturers are in the best position -- with respect to resources and knowledge of their devices -- to investigate the reportable event, perform an analysis, if necessary, to determine why the device may have failed, and to take any necessary corrective actions." HIMA also suggests that "any reportable events form and FDA guidance document describing the new form" should "encourage return of devices to the manufacturer for failure analysis" because "manufacturers must be in a position to receive devices back from the user in an undamaged condition in order to complete a proper failure investigation." FDA plans to publish a draft of the device/drug/biologics form to provide an opportunity for comments. HIMA states that "publication of a draft form, with an ample comment period, is essential...for legal reasons as well as prudential concerns."