Elvisfan schreef op 6 december 2018 10:05:
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class of 2 is natuurlijk belangrijk voor de timing van approval natuurlijk; de kans op class 2 is groot natuurlijk
www.fda.gov/medicaldevices/resourcesf...Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.
Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.
Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.