FDA Proposes Requiring Electronic MDRs

The FDA has proposed a rule requiring that device manufacturers submit all medical device reports (MDRs) electronically, making formal an option that has been available for a few years. CDRH receives 85 percent of the 300,000 MDRs it gets every year in paper format, David Buckles, director of the Division of Postmarket Surveillance, said in a conference call last week. The rule was recently published in the Federal Register and comments are due Nov. 19.
Devices and Diagnostics Letter