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Home » FDA Draft Rule Begins Designation Process for Pre-Amendment Devices
FDA Draft Rule Begins Designation Process for Pre-Amendment Devices
July 29, 2011
More than two years after the FDA began the process of formally classifying 25 types of pre-amendment Class III devices, the agency has begun releasing those determinations, issuing a proposed rule DATE requiring a PMA or notice of completion of product development protocol for implantable pacemaker pulse generators (IPPG).