Nedklassifisering vil âkunâ bety det er lettere Ă„ fĂ„ devicen godkjent, i dette tilfellet et scope.
Som du ser av teksten under sÄ krever det ganske mye bÄde tid og penger nÄr en device ligger under Class 3 VS Class 2.
Class I:
These devices have the lowest risk and are subject to general controls like registration, listing, and adherence to good manufacturing practices. Examples include bandages, tongue depressors, and some wheelchairs.
These devices have a moderate risk and require general controls, as well as special controls like performance standards, postmarket surveillance, and patient registries. Examples include powered wheelchairs and pregnancy test kits.
These devices pose the highest risk and require premarket approval, which involves rigorous scientific evidence of safety and effectiveness. Examples include pacemakers and breast implants.
The classification also determines the regulatory controls required for bringing a device to market, with Class I devices subject to the least and Class III devices subject to the most stringent regulations.
Edit: Kostnad vedrÞrende sÞknadsprosess osv er det R Wolf som vil stÄ for, ref avtalen mellom RW og PHO.