21 CFR Part 812 Flashcards
What does 21 CFR part 812 cover?
Investigational Device Exemptions (IDE)
An approved IDE permits a device to be _________ lawfully for the purpose of conducting investigations of that device.
Shipped
What is an IMPLANT according to 21 CFR part 812?
A device placed into a surgically or naturally formed cavity of the body if it is intended to remain there for a period of 30+ days
The following investigational devices are considered significant risk devices:
1) Device intended as an implant with potential for serious risk to health, safety, or welfare of a subject
2) Device for use in supporting or sustaining human life with potential for serious risk to health, safety, or welfare of a subject
3) Device of substantial importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment to human health with potential for serious risk to….
4) Device that otherwise presents potential for serious risk to….
In regards to an investigation involving exception from informed consent, the study may not proceed without prior _____ authorization from the FDA, which will be provided within ____ days of FDA receiving the IDE application.
Written
30 days
If the FDA accepts info from a study conducted outside of the US in support of an IDE, a sponsor must retain records of the study in support of the IDE for _____ years after termination or completion of the IDE
2 Years
An investigation may not begin until ____ days after FDA receipt of an IDE application.
30 days, unless the FDA notifies the sponsor that the investigation may not begin.
What is the purpose of a treatment IDE?
Facilitates the availability of promising new devices to desperately ill patients
For patients with serious disease AFTER all clinical trials are completed
For patients with immediately life-threatening disease, PRIOR TO the completion of all clinical trials.
How long does a Sponsor have to terminate investigations when they determine that an unanticipated adverse device effect presents an unreasonable risk to subjects?
5 WORKING days after sponsor makes the determination
AND no later than
15 WORKING days after the sponsor first receives notice of the unanticipated adverse device effect
How long shall an Investigator or Sponsor retain records related to their participation in an investigation?
2 years after the latter of the follow
A) the date on which the investigation is terminated or completed
B) the date that the records are no longer required for purposes of supporting a premarket approval application, etc.
An INVESTIGATOR shall report to the sponsor & IRB a report of an unanticipated adverse device effect no later than ____ ___________ days after the investigator first learns of the effect.
10 WORKING
An INVESTIGATOR shall report to the sponsor & IRB any deviation to protect life or physical well-being of a subject in an emergency within ____ _____________ days after the emergency occurred
5 WORKING
An INVESTIGATOR shall submit a _______ report to the IRB and sponsor within ____ __________ of study termination
Final
3 months
The Sponsor shall report unanticipated adverse device effects to the FDA and ALL reviewing IRBs and participating investigators within _____ _________ days after the Sponsor first receives notice of the effect.
10 WORKING days
How often shall the SPONSOR submit progress reports to all IRBs (and the FDA in the case of significant risk device)?
At least yearly
