BMEN 1208 Final Exam 142 correct
answers.
BMEN 1208 Final Exam 142 correct
answers.
Regulation - ANSWER a rule or directive made and maintained by an authority
what are pentalties the usa fda has for medical device regulation - ANSWER product seizure, fines, jail-
time
a medical device - ANSWER diagnoses, cures, lessens, treats or prevents human disease-affects the
function or structure of the body-does not achieve primary intended purpose through chemical action
class 1 medical device - ANSWER simple, low risk of harm to the user, "general controls" that are
sufficient to protect the user, most exempt from major regulations
examples of class 1 devices - ANSWER non-powered breast pump, elastic bandages, tongue depressors,
examination gloves, hearing aids, arm slings, microbial analyzers, keratoscopes
class 2 medical devices - ANSWER more complicated with higher risk, general and special controls,
**permarket notification [510(k)]**(regulatory standard is "substantial equivalence")
types of class 2 devices - ANSWER powered wheelchairs, CT scanners, lenses, endolymphatic shunts,
orthopedic implants, dental implants
class 3 medical devices - ANSWER most complex with highest risk, sustain or support life, are implanted,
or present potential risk of injury, tough regulatory controls **require premarket approval through a
pma** with bench/animal/clinical testing, may need post approval study requirements
what type of class is a cochlear implant - ANSWER 3
what type of class is an elastic bandage - ANSWER 1
, BMEN 1208 Final Exam 142 correct
answers.
what type of device is a ct scanner - ANSWER 2
what type of device is a dental implant - ANSWER 2/3
what type of device is a
1. pacemaker
2. crutches - ANSWER 1. 3
2. 1
what does the maude database stand for and what does it include - ANSWER manufacturer and user
device experience, tracks adverse events and anyone with direct experience can report and
manufacturers must report back
definition of state of equipoise - ANSWER do not truly know which treatment is better, necessary to
even start a trial
type definition for clinical trials - ANSWER observational or interventional, interventional is used in
safety/efficacy studies
masking - ANSWER used to reduce bias, single blind, double blind, or open label
allocation - ANSWER (how participants are assigned to different groups
)randomized common into arms
what guides the IRB (Institutional Review Boards) review process - ANSWER Federal and state
regulations, university policy, belmont report
answers.
BMEN 1208 Final Exam 142 correct
answers.
Regulation - ANSWER a rule or directive made and maintained by an authority
what are pentalties the usa fda has for medical device regulation - ANSWER product seizure, fines, jail-
time
a medical device - ANSWER diagnoses, cures, lessens, treats or prevents human disease-affects the
function or structure of the body-does not achieve primary intended purpose through chemical action
class 1 medical device - ANSWER simple, low risk of harm to the user, "general controls" that are
sufficient to protect the user, most exempt from major regulations
examples of class 1 devices - ANSWER non-powered breast pump, elastic bandages, tongue depressors,
examination gloves, hearing aids, arm slings, microbial analyzers, keratoscopes
class 2 medical devices - ANSWER more complicated with higher risk, general and special controls,
**permarket notification [510(k)]**(regulatory standard is "substantial equivalence")
types of class 2 devices - ANSWER powered wheelchairs, CT scanners, lenses, endolymphatic shunts,
orthopedic implants, dental implants
class 3 medical devices - ANSWER most complex with highest risk, sustain or support life, are implanted,
or present potential risk of injury, tough regulatory controls **require premarket approval through a
pma** with bench/animal/clinical testing, may need post approval study requirements
what type of class is a cochlear implant - ANSWER 3
what type of class is an elastic bandage - ANSWER 1
, BMEN 1208 Final Exam 142 correct
answers.
what type of device is a ct scanner - ANSWER 2
what type of device is a dental implant - ANSWER 2/3
what type of device is a
1. pacemaker
2. crutches - ANSWER 1. 3
2. 1
what does the maude database stand for and what does it include - ANSWER manufacturer and user
device experience, tracks adverse events and anyone with direct experience can report and
manufacturers must report back
definition of state of equipoise - ANSWER do not truly know which treatment is better, necessary to
even start a trial
type definition for clinical trials - ANSWER observational or interventional, interventional is used in
safety/efficacy studies
masking - ANSWER used to reduce bias, single blind, double blind, or open label
allocation - ANSWER (how participants are assigned to different groups
)randomized common into arms
what guides the IRB (Institutional Review Boards) review process - ANSWER Federal and state
regulations, university policy, belmont report
