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Form fda 3514 (1/13) author: Cdrh premarket review submission cover. Web cdrh premarket review submission cover sheet form approval omb no. Web premarket notification truthful and accurate statement; Web download the fda cover sheet for premarket review submissions of medical devices and learn how to fill it out correctly. Medical device user fee cover sheet (form fda 3601) cdrh premarket review submission cover. Web cdrh premarket review submission cover sheet form approval omb no. Web department of health and human services.