Registering a Class II Medical Device with no Predicate Device - FDA

[Mondo 22]

All,

What is the process of regsitering a class II device with the FDA if there is no predicate device?

Any help would be much appreciated

Thanks

 

[Pads38]

Have a look for the FDA guidance on the "de novo" process.

Try here:-

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm