CCRP FINAL EXAM ACTUAL QUESTIONS AND SOLUTIONS
RATED A+
✔✔Medical device - ✔✔Device is NOT dependent on chemical action or being
metabolized and;
-also must be recognized in official national formulary or US pharmacopoeia
-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 1000s of subjects, device
studies usually have 100s of subjects
✔✔Class I (device) - ✔✔Lowest risk
--General controls are sufficient to provider reasonable assurance of the safety and
effectiveness
Ex. powered wheelchairs, infusion pumps, and surgical drapes
✔✔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
RATED A+
✔✔Medical device - ✔✔Device is NOT dependent on chemical action or being
metabolized and;
-also must be recognized in official national formulary or US pharmacopoeia
-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 1000s of subjects, device
studies usually have 100s of subjects
✔✔Class I (device) - ✔✔Lowest risk
--General controls are sufficient to provider reasonable assurance of the safety and
effectiveness
Ex. powered wheelchairs, infusion pumps, and surgical drapes
✔✔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
