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Manufacturers of all in vitro diagnostics now have until June 30, 2015, to file an application for inclusion of currently marketed products on the Australia Register of Therapeutic Goods. Read More
The Utopia Group, a specification developer for an umbilical cord clamp and cutter, received an FDA warning letter for making product changes without following regulations and for lacking a host of procedures. Read More
Devicemakers should never be concerned that an FDA inspector will cite them for opening “too many” corrective and preventative actions, a CDRH official says. Read More