Food and Drug Administration Exam
Questions and Answers 100% Pass
Food and Drug Administration (FDA) - ANSWER-Assures safety, efficacy, and
security of human and veterinary drugs, biological products, medical devices, the
US food supply, cosmetics, and products that emit radiation
Advance public health by speeding innovations that make medicines and food
safer, more effective, and more affordable
Provides public with accurate science-based info to aid in the use of medicines and
foods to improve health
Question: Center for Devices and Radiological Health (CDRH) - ANSWER-
Regulates firms who manufacture, relable, and or important medical devices sold in
the US
Question: 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
, Question: 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
Question: 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
Questions and Answers 100% Pass
Food and Drug Administration (FDA) - ANSWER-Assures safety, efficacy, and
security of human and veterinary drugs, biological products, medical devices, the
US food supply, cosmetics, and products that emit radiation
Advance public health by speeding innovations that make medicines and food
safer, more effective, and more affordable
Provides public with accurate science-based info to aid in the use of medicines and
foods to improve health
Question: Center for Devices and Radiological Health (CDRH) - ANSWER-
Regulates firms who manufacture, relable, and or important medical devices sold in
the US
Question: 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
, Question: 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
Question: 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
