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This article was originally published in The Gray Sheet

Executive Summary

DEVICE ADVERSE INCIDENT REPORTING RATE WILL TRIPLE to over 300,000 reports in the year after new reporting regulations are finalized, FDA staffers predicted July 13 at an agency-sponsored meeting on event reporting in Rockville, Maryland. Isaac Hantman, a biomedical engineer at the device center's office of surveillance and biometrics, said that the Center for Devices and Radiological Health received "just over 100,000" adverse event reports in fiscal year 1992. "Based on precedent, we expect this rate to roughly triple due to [Safe Medical Devices Act of 1990 requirements] and maybe go a little higher as a result of" the agency's recent "MedWatch" initiative to improve reporting by health professionals ("The Gray Sheet" June 7, I&W-4). CDRH is finalizing regulations for the user facility and distributor reporting provisions of SMDA as well as regs to revise manufacturing reporting requirements. User reporting statutes went into effect Nov. 28, 1991; distributor reporting requirements became effective on May 28, 1992. The regs likely will be published in January 1994 at the earliest, according to FDAers. In addition to mandatory reports from manufacturers, users and distributors, the agency also receives voluntary incident reports under a problem reporting program implemented in the 1970s. Upcoming changes in the device incident reporting program should bring greater efficiency to the system and, CDRH hopes, enable the center to process the anticipated surge in reports. Several such changes were discussed at the July 13 meeting, including manufacturers' monthly summary reports, the new standardized MedWatch reporting forms, and electronic data interchange. FDA's proposed manufacturer reporting reg would require firms to submit monthly reports providing summaries and trend analysis of individual reports ("The Gray Sheet" Nov. 25, 1991, p. 1). Commenting on the importance of the data analysis, CDRH Deputy Director for Regulations and Policy Joseph Levitt said that the device center is going to be "looking much more to the manufacturers to do a much more detailed analysis of the data before it comes to us. We can no longer afford to simply be the place where everybody dumps their information, so to speak." Chester Reynolds, director of the issues management staff at OSB, added: "We really can't afford to look at reports on an individual basis anymore. That is an impossible task for us to do. There are too many of them, the issues are too great, it's just not practical and we would fall behind." The incident reporting forms being developed under the MedWatch program also should improve efficiency, Reynolds said, because they will provide CDRH with "a standardized way to look at data very quickly. This is the only way we can survive, and the only way you can survive." At the meeting, CDRH released an interim guidance for manufacturers and distributors on use of the mandatory report form (3500A). Companies may voluntarily use the forms now, but are not required to use them until the final MDR reg goes into effect. The device center notes in the guidance that "the current regulation requires the submission of certain information not specifically included in form 3500A." This information, such as importer name and address, "is to be recorded" under the "additional manufacturer narrative" section of the report form, FDA says. A longer-range goal for CDRH is implementation of a system for the electronic submission of incident reports. "The ultimate cost savings is not having to submit these reports in paper form," Reynolds said. Computerized reporting "will be incredibly preferable to the way we're doing business now." He added that CDRH hopes to hold a series of workshops in the coming year to address EDI and other incident reporting issues. Public Citizen's Health Research Group, in a July 15 letter to FDA on incident reporting issues, urges the agency to retain a provision of the proposed incident reporting regulation that would require manufacturers and distributors to annually certify that "all reportable events were submitted" for the year or that "the firm did not receive information on any reportable events." The consumer advocacy group is "most concerned about apparent industry opposition to the regulation," according to the letter. The group "strongly urge[s] FDA to keep the tentative rule as is when publishing final reporting regulations later this year." This would ensure that companies "will not only have to certify that a certain number of reports were submitted to FDA, but also that the number submitted did, in fact, include all reportable events." "If FDA retreats from its position in the proposed regulations," Public Citizen warns, "there will be two significant repercussions: (1) the agency will send the wrong message, namely that it has relaxed its pressure on industry to be accountable for MDR reporting, and (2) the agency will nullify the intent of the statute." The device industry has raised concerns with the certification provision. At a meeting sponsored by the Health Industry Manufacturers Association in December 1991, Howard Holstein, an attorney with the Washington, D.C. law firm of Hogan & Hartson, said that having to certify that the correct number of reports was submitted is "a rather precarious position to be in" because FDA and the company may have different interpretations of what constitutes a reportable event ("The Gray Sheet" Dec. 9, 1991, p. 3). FDA staffers at the July 13 meeting indicated that the final reg likely will maintain the current certification requirement. Manufacturers "will have to make an annual certification," Wayne Robinson, acting deputy director of postmarket clinical evaluation at OSB, stated. The certification will "tell us the number of reports that you submitted to us, and you will also tell us that those are all [the reports] that you were required to submit."

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