On January 2, 2013, the FDA issued three final guidance documents related to drug and medical device submissions. The first guidance, Acceptance and Filing Reviews for Premarket Approval Applications, is intended to clarify the criteria for accepting and filing a premarket approval application (PMA) to assure the consistency of FDA’s acceptance and filing decisions. The guidance is applicable to original PMAs and PMA panel-track supplements reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The second guidance, eCopy Program for Medical Devices Submissions, explains the new electronic copy (eCopy) Program for medical devices submissions, provides the standards for a valid eCopy, and identifies the submission types that must include an eCopy in accordance with such standards for the submission to be processed and accepted for review by FDA. The final guidance, Refuse to Accept Policy for 510(k)s, explains the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete. The guidance is applicable to 510(k)s reviewed by CDRH and CBER. Comments regarding the guidances may be submitted at any time.