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Citing industry concerns, the FDA has reversed plans for a proposed voluntary presubmission process that would have allowed sponsors to get reviewer feedback before submitting an investigational device exemption application. Read More
The deal leverages existing vascular technologies and customer relationships to drive increased market penetration, the Irish devicemaker says. Read More
ProTech Professional Products received an FDA warning letter for problems with its corrective and preventive action and complaint procedures and for failing to notify the FDA of significant device modifications. Read More
Devicemakers could spare themselves time and money by checking with UDI-issuing agencies to see if they have a current account before applying for new licenses, a former FDA official says. Read More