***器械FDA注册1、2017年***器械企业的FDA年费为3382美金。这也是近三年来FDA年费***降价。如下所示。ApplicationTypeStandard***allBussinessPremarketApplication(PMA,BLA,PSP)234,49558,624PremarketReport(PMR)234,49558,624Panel-TrackPMAsupplement175,87143,968BLAEfficacySupplement234,49558,624180-DayPMASupplement35,1748,794Real-TimePMASupplement16,4154,104PremarketNotification(510(K))4,6902,34530-daynotice3,7521,876513(g)requestforclassificationinformation3,1661,158AnnualfeeforperiodicreportingonaclassIIIdevice8,2072,052EstablishmentRegistrationFee-Thereisnoreducedfeefora***allbusiness.IfthisistheonlyfeeyouexpecttopayduringFY2017,doyousubmitanFY2017***allBusinesssQualificationandCertificationrequest.TypeofFeeAnnualFeeEstablishmentregistrationfee33822、FDA续费企业请于2016年10月1日-2016年12月31日期间缴纳年费，逾期将影响贵司产品销往美国。如果您想继续使用FDA的企业注册号和设备登记号，请注意续费时间并及时申请年费缴纳事宜。3、想进行***FDA注册的制造商或贸易商如需我司协助，请致电：021-31006127，13512157337、18202148021或发邮件至zhaoyuan0520@.（赵园）上海句峰随时为您提供******的注册服务！)