CCEP: Derechos Humanos C3
21 CFR Part 312 vs 21 CFR Part 812 - correct answer-21 CFR Part 312 = FDA Form
1572, Serious Adverse Event
21 CFR Part 812 = Investigational agreement, Unanticipated Adverse Device Effects
21 CFR Part 312.34 - correct answer-Treatment use of an Investigational new drug
21 CFR Part 812 - correct answer-Investigational Device Exemption
21 CFR Part 814 - correct answer-Premarket approval of medical devices
Class I (device) - correct answer-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) - correct answer-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) - correct answer-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
During which phases is a treatment protocol usually made available? - correct
answer-During Phase 3 but if data is compelling, may be available during Phase 2,
OR, after all clinical trials have been completed and Sponsor of trials is
awaiting/pursuing marketing approval
Equity interest in publicly traded company greater than $____ should be reported? -
correct answer-$50,000
Exemption for investigation of a device: Abbreviated Requirements (21 CFR Part
812.2[c]) - correct answer-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:
--noninvasive
--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
How long is the reporting period for equity interest and significant payments? -
correct answer-Study period plus one year
How long is the waiting period before a treatment IND study can be initiated? -
correct answer-30 days
How many days after FDA receives IND submission does the IND go into effect? (21
CFR 312.40) - correct answer-An IND goes into effect 30 days after the FDA
receives the submission unless the FDA notifies the Sponsor of a clinical hold
How many days do you have to report a deviation from an investigational device plan
to Sponsor and IRB, and why? - correct answer-Five days. Deviations are to protect
human life or physical well-being
How many days do you have to report an unanticipated adverse device effect? -
correct answer-As soon as possible, but no later than 10 days after Investigator first
learns of the event
How many days does a Physician or Sponsor have to submit written summary of
expanded access to the FDA after use? - correct answer-15 days
IDE (Investigational Device Exemption) - correct answer-An approved IDE permits
device to be shipped lawfully
Medical device - correct answer-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
Minimal risk - correct answer-The likelihood of harm is no greater than that
encountered in daily life or during routine PE
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