EVOLUTION OF THE FOOD EXAM
SCRIPT WITH CORRECT ANSWERS
◉Center for Devices and Radiological Health (CDRH) . Answer:
Regulates firms who manufacture, relable, and or important medical
devices sold in the US
◉Medical Device . Answer: An instrument, apparatus, implant, in vitro
reagent, or similar or related article that is used to diagnose, prevent, or
treat disease or other conditions, and does not achieve its purposes
through chemical action within or on the body
◉Class I Device . Answer: General Controls; minimal potential for
harm to the user
Subject only to general controls: registration of company with FDA,
GMPs, proper labeling, general reporting
Submission Type: 510(k) Exempt
Ex: dental floss, toothbrush, tongue depressor, gloves, tweezers
, ◉Class II Device . Answer: General Controls with Special Controls:
specialized labeling, post-market surveillance
Typically noninvasive devices, no clinical trials required
Submission Type: 510(k) (Premarket Notification)
~43% of medical devices
Ex: x-ray machine, powered wheelchair, infusion pump, many
orthopedic devices, pregnancy test
◉Class III Device . Answer: General Controls and Premarket Approval
(PMA)
Device that is life-sustaining, life-supporting, or substantially important
in preventing impairment of health; device presents a potential
unreasonable risk of illness or injury; device failure causes life-
threatening injury
Submission Type: 510(k) or PMA
~10% of medical devices
SCRIPT WITH CORRECT ANSWERS
◉Center for Devices and Radiological Health (CDRH) . Answer:
Regulates firms who manufacture, relable, and or important medical
devices sold in the US
◉Medical Device . Answer: An instrument, apparatus, implant, in vitro
reagent, or similar or related article that is used to diagnose, prevent, or
treat disease or other conditions, and does not achieve its purposes
through chemical action within or on the body
◉Class I Device . Answer: General Controls; minimal potential for
harm to the user
Subject only to general controls: registration of company with FDA,
GMPs, proper labeling, general reporting
Submission Type: 510(k) Exempt
Ex: dental floss, toothbrush, tongue depressor, gloves, tweezers
, ◉Class II Device . Answer: General Controls with Special Controls:
specialized labeling, post-market surveillance
Typically noninvasive devices, no clinical trials required
Submission Type: 510(k) (Premarket Notification)
~43% of medical devices
Ex: x-ray machine, powered wheelchair, infusion pump, many
orthopedic devices, pregnancy test
◉Class III Device . Answer: General Controls and Premarket Approval
(PMA)
Device that is life-sustaining, life-supporting, or substantially important
in preventing impairment of health; device presents a potential
unreasonable risk of illness or injury; device failure causes life-
threatening injury
Submission Type: 510(k) or PMA
~10% of medical devices
