21 CFR 812 Flashcards
What is the Title of 21 CFR Part 812
Investigational Device Exemptions
What is the purpose of 21 CFR Part 812?
regulatory requirements for Investigational Device Exemptions (IDEs) to ensure the safety and effectiveness of medical devices in clinical trials.
Who is responsible for compliance with 21 CFR Part 812?
Sponsors, investigators, and institutional review boards (IRBs) are collectively responsible for compliance
What is the definition of an Investigational Device Exemption (IDE) under 21 CFR Part 812?
An IDE allows the investigational use of a medical device in a clinical study to collect safety and effectiveness data required to support a Premarket Approval (PMA) application.
What is the role of the sponsor in the context of 21 CFR Part 812?
The sponsor is responsible for submitting the IDE application, ensuring proper monitoring, reporting adverse events, and maintaining regulatory compliance throughout the clinical trial.
Describe the process of obtaining an IDE according to 21 CFR Part 812.20.
Sponsors must submit an IDE application to the FDA, which includes information on the device, protocol, investigator, monitoring procedures, and consent forms.
What are the criteria for FDA approval of an IDE application under 21 CFR Part 812.30?
The FDA approves an IDE if it determines that the investigation is scientifically sound, will be conducted ethically, and the benefits outweigh the risks.
What are the responsibilities of the investigator as outlined in 21 CFR Part 812.100?
Investigators are responsible for ensuring the study is conducted in accordance with the investigational plan, protecting subjects, obtaining informed consent, and reporting adverse events.
Explain the concept of “Significant Risk” and “Nonsignificant Risk” devices under 21 CFR Part 812.3(m).
A significant risk device poses a potential for serious harm, while a nonsignificant risk device has a lower potential for harm.
Describe the sponsor’s obligations regarding labeling of an investigational device under 21 CFR Part 812.110.
The sponsor must ensure that the labeling of an investigational device complies with FDA requirements and provides adequate directions for use. “ CAUTION - Investigational Device. Limited by Federal law to investigational use.”
Explain the concept of “Premarket Approval (PMA)” and its relationship to 21 CFR Part 812.
Premarket Approval (PMA) is a process by which the FDA evaluates the safety and effectiveness of certain medical devices before they are marketed, and data from IDE studies contribute to this process.
What are the reporting requirements for sponsors regarding adverse events under 21 CFR Part 812.150?
Sponsors must promptly report to the FDA and all reviewing IRBs any adverse events that are both unexpected and related to the use of the device.
Explain the concept of “Emergency Use” of an investigational device under 21 CFR Part 812.36.
Emergency use allows the use of an investigational device in a life-threatening situation for which no alternative treatment is available.
Describe the requirements for the submission of an IDE application for a significant risk device under 21 CFR Part 812.20(b).
Sponsors of significant risk devices must submit a complete IDE application to the FDA before initiating the clinical investigation.
