BME 214 FDA Midterm Exam
With Complete Solution
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)
=>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.
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
Paolo Macchiarini - ANSWER (2010)
, Swedish hospital conducted investigation in surgeon unethical practices.
Performed 3 failed surgeries on patients using the artificial trachea he
created as part of his research (conflict of interest)
Elizabeth Holmes - ANSWER Theranos
FDA - ANSWER Food and Drug Administration
Originated with the Food and Drug Act of 1906
Regulates standards for medical devices and diagnostic purposes
Under US Department of Health and Human Services (HHS)
Uses voluntary compliance but can use court orders to seize dangerous
products
Their authority over medical devices is anything that is intended to diagnose
or treat (but not working through chemical action or metabolism in the
body)
Theranos - ANSWER
What does the FDA regulates? - ANSWER *Food
*Human Drugs
*Biologics
*Animal Drugs
*Cosmetics
*Medical Devices/
Radiological Health
With Complete Solution
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)
=>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.
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
Paolo Macchiarini - ANSWER (2010)
, Swedish hospital conducted investigation in surgeon unethical practices.
Performed 3 failed surgeries on patients using the artificial trachea he
created as part of his research (conflict of interest)
Elizabeth Holmes - ANSWER Theranos
FDA - ANSWER Food and Drug Administration
Originated with the Food and Drug Act of 1906
Regulates standards for medical devices and diagnostic purposes
Under US Department of Health and Human Services (HHS)
Uses voluntary compliance but can use court orders to seize dangerous
products
Their authority over medical devices is anything that is intended to diagnose
or treat (but not working through chemical action or metabolism in the
body)
Theranos - ANSWER
What does the FDA regulates? - ANSWER *Food
*Human Drugs
*Biologics
*Animal Drugs
*Cosmetics
*Medical Devices/
Radiological Health
