©BRAINBARTER EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
BME 214 FDA Midterm Exam Study Guide.
Good tech must be... - answer✔* Safety and efficacy (produces desired results)
*Companies must validate/verify both
Medical Device - answer✔All articles intended for use in diagnosis or treatment of diseases or
to affect the structure/function of the body, but no working through chemical action/
metabolism on the body
Product Development - answer✔Idea->invention
=>Marketing research/IP rights
=>New product development (1)
=>Manufacturing (2)
1|Page
, ©BRAINBARTER EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
=>Regulatory plan (3)
*Failure at Steps 1-3 makes process return back to step 1
=>Reimbursement/Sales/Marketing/ Distribution
Problem with emerging technology - answer✔Boundaires between drugs and biologics is less
obvious
Drug - answer✔Any article....
1) recognized by the US pharmacopoeia
2) used in diagnosis/cure/treatment/
prevention of disease in human/animal
3) intended to affect the structure/function of human/animal
*can be a food/dietary ingredient/dietary supplement
Biologic - answer✔A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component or derivative, allergenic product or analogous product, or arsphenamine or
derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the
prevention, treatment or cure of a disease or condition of human beings.
2|Page
, ©BRAINBARTER EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
Linda Gross V. Ethicon - answer✔J&J being sued
Prolift transvaginal mesh
Ethicon engineer ignored internal documents about safety and efficacy of transvaginal mesh in
order to bring it to market faster
Recall Notice - answer✔Healthcare professionals and patients report side/effects of medical
device to FDA's MedWatch
Safety Information and Adverse Event Reporting Program
ex. PROMEFUR Neck Varus/Valgus
Company: MicroPort Orthopedics Inc.
product used in total hip replacement; unexpected rate of fractures post-surgery
voluntary recall
3|Page
ALL RIGHTS RESERVED.
BME 214 FDA Midterm Exam Study Guide.
Good tech must be... - answer✔* Safety and efficacy (produces desired results)
*Companies must validate/verify both
Medical Device - answer✔All articles intended for use in diagnosis or treatment of diseases or
to affect the structure/function of the body, but no working through chemical action/
metabolism on the body
Product Development - answer✔Idea->invention
=>Marketing research/IP rights
=>New product development (1)
=>Manufacturing (2)
1|Page
, ©BRAINBARTER EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
=>Regulatory plan (3)
*Failure at Steps 1-3 makes process return back to step 1
=>Reimbursement/Sales/Marketing/ Distribution
Problem with emerging technology - answer✔Boundaires between drugs and biologics is less
obvious
Drug - answer✔Any article....
1) recognized by the US pharmacopoeia
2) used in diagnosis/cure/treatment/
prevention of disease in human/animal
3) intended to affect the structure/function of human/animal
*can be a food/dietary ingredient/dietary supplement
Biologic - answer✔A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component or derivative, allergenic product or analogous product, or arsphenamine or
derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the
prevention, treatment or cure of a disease or condition of human beings.
2|Page
, ©BRAINBARTER EXAM SOLUTIONS 2024/2025
ALL RIGHTS RESERVED.
Linda Gross V. Ethicon - answer✔J&J being sued
Prolift transvaginal mesh
Ethicon engineer ignored internal documents about safety and efficacy of transvaginal mesh in
order to bring it to market faster
Recall Notice - answer✔Healthcare professionals and patients report side/effects of medical
device to FDA's MedWatch
Safety Information and Adverse Event Reporting Program
ex. PROMEFUR Neck Varus/Valgus
Company: MicroPort Orthopedics Inc.
product used in total hip replacement; unexpected rate of fractures post-surgery
voluntary recall
3|Page
