MDUFA III Guidance Documents Final Release

OMEDtechNews & EventsLeave a Comment

FDA released three MDUFA III guidance documents on 12/31/2012.  Happy New Year!  The guidance documents discuss key provisions of MDUFA III.  The guidances are on the eCopy program, Premarket Approval Applications and 510(k) files acceptance criteria.  For a little light reading, check out this link.