FDA Product Code OUG: Medical Device Data System

A Medical Device Data System (mdds) Is A Device That Is Intended To Provide One Or More Of The Following Uses, Without Controlling Or Altering The Functions Or Parameters Of Any Connected Medical Devices: (i) The Electronic Transfer Of Medical Device Data; (ii) The Electronic Storage Of Medical Device Data; (iii) The Electronic Conversion Of Medical Device Data From One Format To Another Format In Accordance With A Preset Specification; Or (iv) The Electronic Display Of Medical Device Data. (2) An Mdds May Include Software, Electronic Or Electrical Hardware Such As A Physical Communications Medium (including Wireless Hardware), Modems, Interfaces, And A Communications Protocol. This Identification Does Not Include Devices Intended To Be Used In Connection With Active Patient Monitoring.