what is an fda class 1 medical device
Medical device
Class I devices are subject to the least regulatory control . Class I devices are subject to `` General Controls '' as are Class II and Class III devices . General controls include provisions that relate to adulteration ; misbranding ; device registration and listing ; premarket notification ; banned devices ; notification , including repair , replacement , or refund ; records and reports ; restricted devices ; and good manufacturing practices . Class I devices are not intended to help support or sustain life or be substantially important in preventing impairment to human health , and may not present an unreasonable risk of illness or injury . Most Class I devices are exempt from the premarket notification and a few are also exempted from most good manufacturing practices regulation . Examples of Class I devices include elastic bandages , examination gloves , and hand - held surgical instruments . Class 
Class I devices are subject to the least regulatory control . Class I devices are subject to `` General Controls '' as are Class II and Class III devices . General controls include provisions that relate to adulteration ; misbranding ; device registration and listing ; premarket notification ; banned devices ; notification , including repair , replacement , or refund ; records and reports ; restricted devices ; and good manufacturing practices . Class I devices are not intended to help support or sustain life or be substantially important in preventing impairment to human health , and may not present an unreasonable risk of illness or injury . Most Class I devices are exempt from the premarket notification and a few are also exempted from most good manufacturing practices regulation . Examples of Class I devices include elastic bandages , examination gloves , and hand - held surgical instruments . Class
Class I devices are not intended to help support or sustain life. Examples of Class I devices include elastic bandages, examination gloves and hand-held surgical instruments.
Class I devices are not intended to help support or sustain life or be substantially important in preventing impairment to human health , and may not present an unreasonable risk of illness or injury . Examples of Class I devices include elastic bandages , examination gloves , and hand - held surgical instruments .
Class I devices are subject to "General Controls" and they are not intended to help support or sustain life or be substantially important in preventing impairment to human health , and may not present an unreasonable risk of illness or injury. Examples of Class I devices include elastic bandages , examination gloves , and hand - held surgical instruments .
Class I devices are subject to `` General Controls '' as are Class II and Class III devices . Class I devices are not intended to help support or sustain life or be substantially important in preventing impairment to human health , and may not present an unreasonable risk of illness or injury . Examples of Class I devices include elastic bandages , examination gloves , and hand - held surgical instruments .