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Food and Drug Administration Questions
and Correct Answers
Food and Drug Administration (FDA) Ans: — 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
Center for Devices and Radiological Health (CDRH) Ans: —
Regulates firms who manufacture, relable, and or important
medical devices sold in the US
Medical Device Ans: — 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 Ans: — 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
© 2025 All rights reserved
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Class II Device Ans: — 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 Ans: — 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
Ex: implantable pacemakers, breast implants
Premarket Notification: 510(k) Ans: — Device must be proven to be
substantially equivalent to a device that was legally marketed
before the Medical Device Amendments were passed (1976)
© 2025 All rights reserved
Food and Drug Administration Questions
and Correct Answers
Food and Drug Administration (FDA) Ans: — 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
Center for Devices and Radiological Health (CDRH) Ans: —
Regulates firms who manufacture, relable, and or important
medical devices sold in the US
Medical Device Ans: — 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 Ans: — 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
© 2025 All rights reserved
, 2 | Page
Class II Device Ans: — 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 Ans: — 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
Ex: implantable pacemakers, breast implants
Premarket Notification: 510(k) Ans: — Device must be proven to be
substantially equivalent to a device that was legally marketed
before the Medical Device Amendments were passed (1976)
© 2025 All rights reserved
