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FDA Proposes Mandatory Electronic Reporting of Adverse Events

Aug 21, 2009 | Parker Waichman LLP

The Food & Drug Administration (FDA) has proposed two new regulations aimed at improving access to and analysis of safety information provided by the medical product industry. The two proposed rules will apply to the FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).  

Currently, the Centers receive most adverse event reports on paper.  Medical device adverse event reports are manually entered into  the Manufacturer and User Facility Device Experience (MAUDE) database.  Likewise, drug and biologic side effects reported to CDER and CBER  are manually entered into the FDA's  Adverse Event Reporting System (AERS). The FDA says this step is  costly and  hinders the Centers' ability to review safety data quickly to uncover potential public health problems.

The proposed regulations for medical devices, drugs and biologics  would require manufacturers and others in the supply chain to submit adverse event reports to the FDA in electronic format, which will be loaded into the MAUDE and AERS databases. This will eliminate manual processing of paper forms by both manufacturers and the FDA.

“Both proposed rules will improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the CDRH, said in a statement on the agency's Web site. “Information obtained from these reports may be critical to future action that improves patient safety.”

“Electronic reporting of serious and unexpected adverse experiences will reduce industry costs and encourage better communication with the FDA and other regulators,” said Gerald J. Dal Pan, M.D., director of CDER’s Office of Surveillance and Epidemiology.

Both new rules would apply to medical products already approved for use.  According to a statement posted on the FDA  Web  site, neither proposed rule changes what types of incidents are required to be reported.


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