Since 2003 FDA staff has used a guidance document to satisfy (21 CFR 814.42(e)) which identifies the criteria for filing a Premarket Approval (PMA). While this guidance has served its purpose in helping provide a basis for FDA to accept or refuse a PMA, a new guidance was just released, “Acceptance and Filing review for Premarket Approval Applications” which FDA hopes will “clarify the criteria for accepting and filing a PMA, thereby enhancing the consistency of our acceptance and filing decision.”