FDA clarifies its proposed mandate, but still has 35 questions for stakeholders.
FDA has issued its proposed rule that would require most medical devices distributed in the United States to bear a unique device identifier (UDI). FDA believes that its proposal would ???reduce medical errors,??? enable ???more rapid, more efficient??? recalls, and ???lead to more accurate reporting of adverse events.??? The rule, published on July 10 in the Federal Register, also proposes an open database and standardized date formats for medical device labels. FDA is seeking comment on the proposal by November 7.