On August 21, 2009, the FDA published two proposed rules that would require manufacturers and other covered entities to report adverse drug, biological, and device events electronically. The FDA expects that the proposed changes would help it “more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission.” In the first rule, the FDA is proposing to amend its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. Likewise, with regard to devices, the FDA is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities use an electronic format to submit mandatory reports of individual medical device adverse events. Comments on both rules will be accepted until November 19, 2009, and comments on related information collection issues are due September 21, 2009. Separately, the FDA released a draft guidance document that provides recommendations on how to prepare and submit electronic medical device reports to FDA in a manner that satisfies the proposed rule; comments on the draft are requested by November 19, 2009.