Home » Proposed Rule for Mandatory eMDR Scheduled for February
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.
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