BME 214 Study Guide With
Complete Solution
Miller Amendment - ANSWER 1948, affirmed that the goods regulated by the
agency have been transported and reached the consumer
Thalidomide - ANSWER 1962, and it was a new sleeping pill found to have
caused birth defects in thousands of babies born in Western Europe.
Medical Device Amendment - ANSWER 1976, and the amendments required
manufacturers to register with the FDA and follow quality control
procedures. wanted to assure SAFETY and EFFICACY
Durham Humphrey - ANSWER 1951, created some drugs only for sale by
prescription
FDA modernization act - ANSWER 1997, provisions including measure to
accelerate review of devices, and regulate advertising of unapproved drugs
and devices, and regulate health claims for foods.
CIDER - ANSWER Center for Infectious disease epidemiologic research
Medical Device - ANSWER An instrument that is used to diagnose or prevent
disease or other conditions. Does NOT achieve its purpose through chemical
reactions of the body, such as metabolism
Class III - ANSWER PMA - pre-market approval
- No predicate Device
Class II - ANSWER General and Special Controls
,Class I - ANSWER General Controls
Adulterated Device - ANSWER Differs from the quality represented on its
labeling
Misbranded Device - ANSWER - labeling is false
- fails to bear a level containing the name & address of manufacturer
- doesn't warn against misuse
- is dangerous when used as directed.
HHS - ANSWER Stands for Health and Human Services department, and is in
conjunction with the FDA agency. FDA regulates food and devices found
within the interstate commerce.
Number of centers under the commissioner - ANSWER 8
IND - ANSWER Institutional New Drug
CDRH - ANSWER Center Devices and Radiological Health, affiliates with the
FDA.
-The FDA Center that conducts the Evaluation Process That Governs the
Ability to Market a Medical Device or a Related Combination Product
in the US
6 centers of CDRH - ANSWER 1- Device Evaluation
2- In Vitro Diagnostic devices and safety
3- Science and Technology
4- Health and industry programs
, 5- compliance
6- Surveillance and biometrics
Exempt Devices - ANSWER Most Class I and some Class II
devices do not need to be cleared for marketing
- stethoscope, medical exercise
equipment
510(k) = Premarket Notification - ANSWER Most Class II devices
- cemented hip implant, x-ray machine
- Used for devices that are substantially
equivalent (SE) to a predicate device
PMA = premarket approval - ANSWER Most Class III devices
- implantable pacemaker, stair climbing wheelchair
General Controls - ANSWER Apply to all devices under the 1976 Medical
device amendment. Basic provisions
IDE - ANSWER Investigational Device Exemptions
- (SR - Significant Risk)
21 CFR part 812 , clinical study protocal
- (NSR - non Significant Risk)
IRB approval, informed consent, no FDA
-All clinical studies of
Complete Solution
Miller Amendment - ANSWER 1948, affirmed that the goods regulated by the
agency have been transported and reached the consumer
Thalidomide - ANSWER 1962, and it was a new sleeping pill found to have
caused birth defects in thousands of babies born in Western Europe.
Medical Device Amendment - ANSWER 1976, and the amendments required
manufacturers to register with the FDA and follow quality control
procedures. wanted to assure SAFETY and EFFICACY
Durham Humphrey - ANSWER 1951, created some drugs only for sale by
prescription
FDA modernization act - ANSWER 1997, provisions including measure to
accelerate review of devices, and regulate advertising of unapproved drugs
and devices, and regulate health claims for foods.
CIDER - ANSWER Center for Infectious disease epidemiologic research
Medical Device - ANSWER An instrument that is used to diagnose or prevent
disease or other conditions. Does NOT achieve its purpose through chemical
reactions of the body, such as metabolism
Class III - ANSWER PMA - pre-market approval
- No predicate Device
Class II - ANSWER General and Special Controls
,Class I - ANSWER General Controls
Adulterated Device - ANSWER Differs from the quality represented on its
labeling
Misbranded Device - ANSWER - labeling is false
- fails to bear a level containing the name & address of manufacturer
- doesn't warn against misuse
- is dangerous when used as directed.
HHS - ANSWER Stands for Health and Human Services department, and is in
conjunction with the FDA agency. FDA regulates food and devices found
within the interstate commerce.
Number of centers under the commissioner - ANSWER 8
IND - ANSWER Institutional New Drug
CDRH - ANSWER Center Devices and Radiological Health, affiliates with the
FDA.
-The FDA Center that conducts the Evaluation Process That Governs the
Ability to Market a Medical Device or a Related Combination Product
in the US
6 centers of CDRH - ANSWER 1- Device Evaluation
2- In Vitro Diagnostic devices and safety
3- Science and Technology
4- Health and industry programs
, 5- compliance
6- Surveillance and biometrics
Exempt Devices - ANSWER Most Class I and some Class II
devices do not need to be cleared for marketing
- stethoscope, medical exercise
equipment
510(k) = Premarket Notification - ANSWER Most Class II devices
- cemented hip implant, x-ray machine
- Used for devices that are substantially
equivalent (SE) to a predicate device
PMA = premarket approval - ANSWER Most Class III devices
- implantable pacemaker, stair climbing wheelchair
General Controls - ANSWER Apply to all devices under the 1976 Medical
device amendment. Basic provisions
IDE - ANSWER Investigational Device Exemptions
- (SR - Significant Risk)
21 CFR part 812 , clinical study protocal
- (NSR - non Significant Risk)
IRB approval, informed consent, no FDA
-All clinical studies of
