SOCRA CORE EXAM TEST UPDATED QUESTIONS AND
SOLUTIONS RATED A+
✔✔Phase 3 Clinical Trials are conducted to: - ✔✔-Confirmation of short-term efficacy
and establish long term efficacy
-Establish benefit-risk relationship
-Provide adequate basis for labeling
-Several hundred to several thousand subjects
✔✔Phase 4 - ✔✔Post-marketing
Continue assessing overall therapeutic value
size depends on design
✔✔When was the Federal Food, Drug, and Cosmetic Act established & why? -
✔✔1938; to establish the FDA's jurisdiction over cosmetic and medical devices in the
US.
✔✔What year did they amend the Federal Food Drug and Cosmetic act specifically for
medical devices? - ✔✔1976
✔✔21 CFR Part 812 - ✔✔Investigational Device Exemption
✔✔21 CFR Part 814 - ✔✔Premarket approval of medical devices
✔✔Medical Device - ✔✔Device is NOT dependent on chemical action or being
metabolized, and;
-also must be recognized in official national formulary or US pharmacopeia
-intended for use in the diagnosis, treatment, mitigation or prevention of disease in man
or other animals
✔✔What are the clinical development stages for devices? - ✔✔1) Pilot Study
2) Pivotal Study
3) Post-market studies
Compared to drugs and biologics, which typically have 1000's of subjects, device
studies usually have 100's of subjects
✔✔Class I (device) - ✔✔Lowest risk
--General controls are sufficient to provide reasonable assurance of the safety and
affectiveness
Ex. elastic bandages, examination gloves, hand-held surgical instruments
✔✔Class II (device) - ✔✔Moderate risk, usually requires a 510k (Pre-Market submission
made to FDA)
--General controls are insufficient to assure safety and effectiveness.
,--Special controls include: special labeling requirements, mandatory performance
standards, post-market surveillance
Ex: powered wheelchairs, infusion pumps, and surgical drapes
✔✔Class III (device) - ✔✔Highest risk, usually requires a 510k (Pre-Market submission
made to FDA)
-Usually those that support or sustain human life
-Important for preventing impairment of human health
-Present a potential risk of illness or injury
Ex. implant, used in supporting or sustaining human life
✔✔Pre-Market Approval (PMA) - ✔✔Required process of scientific review (usually class
III) to ensure reasonable safety and effectiveness of device.
*Must be FDA "approved" or NOT cleared before marketing per 21 CFR Part 814
✔✔Pilot Studies (device) - ✔✔Exploratory
Includes small numbers of subjects
✔✔Pivotal Studies (device) - ✔✔Determine safety and effectiveness
Include most of overall subject numbers
✔✔Post-market Studies - ✔✔Design improvement
Expansion of safety and effectiveness data
Development of new uses
✔✔What are the abbreviated requirements for device studies? 21 CFR Part 812.2(b) -
✔✔Abbreviated Requirements:
-Label device
-Ensure Investigators maintain records and make reports
-Obtain IRB approval: significant risk (SR) vs non-significant risk (NSR)
-Informed consent
-Monitoring of studies
-Refrain from promotion
✔✔Exemption for Investigation of a Device
Abbreviated Requirements 21 CFR Part 812.2(c) - ✔✔Categories of investigations
considered to have approved IDE applications, unless FDA has notified sponsor
otherwise.
-Those in use in accordance with its labeling & in commercial distribution before 5-28-
1976
-A diagnostic device if the testing is:
—-non-invasive
—-does not require invasive sampling of significant risk
—-does not introduce energy into subjects, and,
, —-is not used as a diagnostic procedure without confirmation by another medically
established diagnostic product/procedure
-Device undergoing consumer preference testing, modification testing, or combo of
2/more devices in commercial distribution
-Device solely for veterinary use or lab animal research
✔✔Who designates a device study as significant risk (SR) or non-significant risk
(NSR)? - ✔✔The Sponsor makes the initial determination of SR or NSR and then the
IRB evaluates the study.
Sometimes the IRB may defer to the FDA to make the initial determination.
✔✔Minimal risk - ✔✔The likelihood of harm is no greater than that encountered in daily
life or during routine PE.
✔✔IDE (Investigational Device Exemption) - ✔✔An approved IDE permits device to be
shipped lawfully.
✔✔21 CFR Part 312 vs 21 CFR Part 812 - ✔✔21 CFR Part 312 = FDA Form 1572
21 CFR Part 812 = Investigational Agreement
21 CFR Part 312 = Serious Adverse Event
21 CFR Part 812 = Unanticipated Adverse Device Effects
✔✔How many days do you have to report a deviation from an investigational device
plan to Sponsor and IRB, and why? - ✔✔5 days. Deviations are to protect human life or
physical well-being.
✔✔How many days do you have to report an unanticipated adverse device effect? -
✔✔As soon as possible, but no later than 10 days after Investigator first learns of the
event.
✔✔What must a Sponsor do if they determine that investigational product presents
significant and unreasonable risk to Subjects? - ✔✔1) Immediately discontinue all
studies that present risk
2) Report to FDA and IRB
3) Assure return and accounting for all investigational products/devices
✔✔Sponsor Responsibilities - ✔✔1. Maintain an effective IND or IDE
2. Ensure studies are conducted according to the general investigative plan and
protocols in IND/IDE
3. Promptly report adverse events
4. Select qualified Investigators
5. Provide information such as: investigative brochure
6. Ensure proper monitoring (medical monitor, DSMB, on-site monitoring)
7. Manufacture and label drug/device
SOLUTIONS RATED A+
✔✔Phase 3 Clinical Trials are conducted to: - ✔✔-Confirmation of short-term efficacy
and establish long term efficacy
-Establish benefit-risk relationship
-Provide adequate basis for labeling
-Several hundred to several thousand subjects
✔✔Phase 4 - ✔✔Post-marketing
Continue assessing overall therapeutic value
size depends on design
✔✔When was the Federal Food, Drug, and Cosmetic Act established & why? -
✔✔1938; to establish the FDA's jurisdiction over cosmetic and medical devices in the
US.
✔✔What year did they amend the Federal Food Drug and Cosmetic act specifically for
medical devices? - ✔✔1976
✔✔21 CFR Part 812 - ✔✔Investigational Device Exemption
✔✔21 CFR Part 814 - ✔✔Premarket approval of medical devices
✔✔Medical Device - ✔✔Device is NOT dependent on chemical action or being
metabolized, and;
-also must be recognized in official national formulary or US pharmacopeia
-intended for use in the diagnosis, treatment, mitigation or prevention of disease in man
or other animals
✔✔What are the clinical development stages for devices? - ✔✔1) Pilot Study
2) Pivotal Study
3) Post-market studies
Compared to drugs and biologics, which typically have 1000's of subjects, device
studies usually have 100's of subjects
✔✔Class I (device) - ✔✔Lowest risk
--General controls are sufficient to provide reasonable assurance of the safety and
affectiveness
Ex. elastic bandages, examination gloves, hand-held surgical instruments
✔✔Class II (device) - ✔✔Moderate risk, usually requires a 510k (Pre-Market submission
made to FDA)
--General controls are insufficient to assure safety and effectiveness.
,--Special controls include: special labeling requirements, mandatory performance
standards, post-market surveillance
Ex: powered wheelchairs, infusion pumps, and surgical drapes
✔✔Class III (device) - ✔✔Highest risk, usually requires a 510k (Pre-Market submission
made to FDA)
-Usually those that support or sustain human life
-Important for preventing impairment of human health
-Present a potential risk of illness or injury
Ex. implant, used in supporting or sustaining human life
✔✔Pre-Market Approval (PMA) - ✔✔Required process of scientific review (usually class
III) to ensure reasonable safety and effectiveness of device.
*Must be FDA "approved" or NOT cleared before marketing per 21 CFR Part 814
✔✔Pilot Studies (device) - ✔✔Exploratory
Includes small numbers of subjects
✔✔Pivotal Studies (device) - ✔✔Determine safety and effectiveness
Include most of overall subject numbers
✔✔Post-market Studies - ✔✔Design improvement
Expansion of safety and effectiveness data
Development of new uses
✔✔What are the abbreviated requirements for device studies? 21 CFR Part 812.2(b) -
✔✔Abbreviated Requirements:
-Label device
-Ensure Investigators maintain records and make reports
-Obtain IRB approval: significant risk (SR) vs non-significant risk (NSR)
-Informed consent
-Monitoring of studies
-Refrain from promotion
✔✔Exemption for Investigation of a Device
Abbreviated Requirements 21 CFR Part 812.2(c) - ✔✔Categories of investigations
considered to have approved IDE applications, unless FDA has notified sponsor
otherwise.
-Those in use in accordance with its labeling & in commercial distribution before 5-28-
1976
-A diagnostic device if the testing is:
—-non-invasive
—-does not require invasive sampling of significant risk
—-does not introduce energy into subjects, and,
, —-is not used as a diagnostic procedure without confirmation by another medically
established diagnostic product/procedure
-Device undergoing consumer preference testing, modification testing, or combo of
2/more devices in commercial distribution
-Device solely for veterinary use or lab animal research
✔✔Who designates a device study as significant risk (SR) or non-significant risk
(NSR)? - ✔✔The Sponsor makes the initial determination of SR or NSR and then the
IRB evaluates the study.
Sometimes the IRB may defer to the FDA to make the initial determination.
✔✔Minimal risk - ✔✔The likelihood of harm is no greater than that encountered in daily
life or during routine PE.
✔✔IDE (Investigational Device Exemption) - ✔✔An approved IDE permits device to be
shipped lawfully.
✔✔21 CFR Part 312 vs 21 CFR Part 812 - ✔✔21 CFR Part 312 = FDA Form 1572
21 CFR Part 812 = Investigational Agreement
21 CFR Part 312 = Serious Adverse Event
21 CFR Part 812 = Unanticipated Adverse Device Effects
✔✔How many days do you have to report a deviation from an investigational device
plan to Sponsor and IRB, and why? - ✔✔5 days. Deviations are to protect human life or
physical well-being.
✔✔How many days do you have to report an unanticipated adverse device effect? -
✔✔As soon as possible, but no later than 10 days after Investigator first learns of the
event.
✔✔What must a Sponsor do if they determine that investigational product presents
significant and unreasonable risk to Subjects? - ✔✔1) Immediately discontinue all
studies that present risk
2) Report to FDA and IRB
3) Assure return and accounting for all investigational products/devices
✔✔Sponsor Responsibilities - ✔✔1. Maintain an effective IND or IDE
2. Ensure studies are conducted according to the general investigative plan and
protocols in IND/IDE
3. Promptly report adverse events
4. Select qualified Investigators
5. Provide information such as: investigative brochure
6. Ensure proper monitoring (medical monitor, DSMB, on-site monitoring)
7. Manufacture and label drug/device
