Public Reporting of Adverse Events in Device Trials Goes into Effect on September 27, 2009,
Under Default Provisions of FDAAA

As of September 27, 2008, FDA has required medical device companies to publicly report the overall results of clinical trials involving medical devices regulated under various sections of the Federal Food, Drug, and Cosmetic Act.(1)  Beginning September 27, 2009, the agency will also require device firms to publicly report adverse events occurring in these studies, prompting debate and provoking opposition from device industry groups.(2)

Under the Food & Drug Administration Amendments Act of 2007 (“FDAAA”), drug and device companies are required to register their clinical trials with the National Institutes of Health (“NIH”), which posts general clinical trial information on the public website, ClinicalTrials.gov.(3)  FDAAA also requires drug and device companies to post the results of such trials on the ClinicalTrials.gov website.(4)  Though this provision originally applied only to drugs, apparently due to an inadvertent omission during the final negotiations on FDAAA, a “technical corrections” bill passed by the House of Representatives on July 30, 2008, extended the requirement to medical device trials.(5)  The House bill became law on August 14, 2008.(6) 

As a result, as of September 2008, device companies have been required to report the “basic results” of any studies involving medical devices that would ultimately be cleared or approved for marketing via the premarket approval process, the premarket notification process, or the humanitarian device exemption provisions.(7)  Under the law, device companies are required to submit either “basic results,” a certification for delayed results (allowing submission of results on a delayed schedule), or a request for an extension, within one year of either the estimated study completion date or the actual completion date, whichever is earlier.(8)

As part of the new reporting requirements, beginning September 27, 2009, device companies also must begin posting adverse event data from these studies on the ClinicalTrials.gov website, a requirement that reflects certain “default provisions” of FDAAA.  Specifically, under the technical amendment to FDAAA, NIH was required to issue a regulation by March 27, 2009, addressing the best method for including adverse event data on the ClinicalTrials.gov website.(9)  If NIH failed to issue this regulation, default provisions for reporting adverse events would go into effect on September 27, 2009.(10)  As NIH failed to issue this regulation, it is required to begin including tables in ClinicalTrials.gov entries for clinical study sponsors to list serious adverse events or any events that exceed a frequency of 5% within any arm of the clinical trial, grouped by organ system.(11) 

For companies seeking guidance on which “basic results” and adverse events to report, NIH has recently published a detailed draft document defining “basic results,” serious adverse events, and addressing what data elements are required to be posted on ClinicalTrials.gov.(12)  NIH intends to interpret these definitions and requirements in regulations or guidance, to be issued at a later date, but in the meantime, the draft document is all that is currently available to industry, and is available at http://prsinfo.clinicaltrials.gov/results_definitions.html.  Additionally, NIH has posted a “training webinar” and general information on common errors and helpful hints to assist device firms in submitting results and adverse events data, which is available at http://prsinfo.clinicaltrials.gov/fdaaa.html.(13)

The new reporting requirements have not been popular with device industry trade groups, who feel the FDAAA requirements were intended only to apply to clinical trials of drugs, not devices, despite passage of the technical amendment.(14)  Additionally, members of the device industry have noted that reporting requirements and adverse event definitions differ in FDA’s drug and device regulations, such that it may be difficult for events from drug and device trials to be reported in the same manner on ClinicalTrials.gov.(15)  Device industry trade group AdvaMed says it is seeking more “clarity and context” before providing comments to NIH that would suggest possible revisions to the adverse event reporting criteria.(16)