Calculate FDA Medical Device Registration Cost [Cost calculated per technical documentation] Please enable JavaScript in your browser to complete this form. - Step 1 of 2FDA Medical Device Registration Cost Calculator Medical Device ClassII s/m/rIIaIIbIIINumber of Models123<5<10Difference in design and intended use not considered under models.Number of variants01-56-1011-1516-20SterilisationNoYesETO, GAMMA, STEAMSoftwareNot IntegratedIntegratedFirmware / SIMDNano ParticlesYesNoAnimal derivatives / materials usedNoYesType of ImpalntsNoPartial ImplantsImplantsAccessoriesNIL2-45-9Support, supplement, and/or augment the performance of main device.ConsumablesNil2-45-9Is the device used at Home?NoYesDoes the device include Drug?NADrug Device Combination (NBoP)Ancillary Medicinal DeviceTotal Summary Name Total ($) Medical Device Class I I s/m/r IIa IIb III II s/m/r IIaIIbIIINumber of Models 1 2 3 <5 <10 123<5<10Number of variants 0 1-5 6-10 11-15 16-20 1-56-1011-1516-20Sterilisation No Yes NoYesSoftware Not Integrated Integrated Not IntegratedIntegratedNano Particles Yes No YesNoAnimal derivatives / materials used No Yes NoYesType of Impalnts No Partial Implants Implants NoPartial ImplantsImplantsAccessories NIL 2-4 5-9 NIL2-45-9Consumables Nil 2-4 5-9 Nil2-45-9Is the device used at Home? No Yes NoYesDoes the device include Drug? NA Drug Device Combination (NBoP) Ancillary Medicinal Device NADrug Device Combination (NBoP)Ancillary Medicinal DeviceTotal ($) TotalNextName *Email *Phone *PreviousSend Email EU Authorized Representative Fee CalculatorMDR 2017/745 Notified Body Fee CalculatorBiocompatibility Testing Cost CalculatorMDR 2017/745 - Back to Pricing Page
