Proposed Rule for Mandatory eMDR Scheduled for February

A proposed FDA rule to make electronic medical device reporting (eMDR) mandatory is scheduled for release in February.

After collecting comments on the proposal, the agency will issue a final rule, giving companies a year to begin eMDR.

CDRH does not expect companies to have a difficult time making the transition to an electronic reporting form, according to Don St. Pierre, head of CDRH’s Postmarket Transformation Management Group.