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The FDA should exempt certain biologic grafts from its “sweeping proposed reclassification” of surgical mesh, Cook Biotech says in comments on a proposal to place mesh for transvaginal pelvic organ prolapse repairs in Class III. Read More
The International Medical Device Regulators Forum has released two final guidance documents aimed at easing the filing process for marketing authorizations of medical devices and in vitro diagnostic devices in multiple countries. 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