Questions and Answers
ICH is an abbreviation for which of the following?
Which of the following are required in order to remain in compliance with federal regulations for a significant risk Class III device with no predicate device?
Which of the following does not achieve its primary intended purpose through chemical action within or on the body?
FDA regulations governing medical device clinical investigations in the U.S. include which of the following?
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When conducting clinical research in Tibet, what cultural consideration should be made?
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What is the main difference between drug and device development in the U.S.?
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Which of the following is an example of a Class I device?
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Which of the following is an example of a Class III device?
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Which of the following describes the regulatory pathway to market approval for a combination drug/device product?
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A Class II medical device presents which of the following?
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Which of the following regulatory paths are available for the development of devices for rare conditions?
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The Office of Combination Products determines which of the following?
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Study Notes
Medical Device Regulation and Approval
- ICH stands for International Conference on Harmonisation, focusing on regulatory guidelines across different countries.
- Class III devices, categorized as significant risk, require IND and IDE compliance before clinical trials, along with IRB review throughout the study.
- A medical device does not achieve its primary purpose through chemical action; it functions mechanically rather than through metabolism.
FDA Regulations and Clinical Investigations
- FDA regulations relevant to medical device investigations are articulated in 21 CFR 812.
- Clinical research in culturally distinct areas like Tibet necessitates alternative risk communication methods rather than standard practices.
- Investigational device research is class- and risk-based, differing from drug research which mandates informed consent across all clinical trials.
Classifications of Medical Devices
- Class I devices, such as tongue depressors, are considered the least hazardous, subject only to general controls.
- Class III devices, like vertebral implants, present significant risk and require stringent regulatory scrutiny.
- The Humanitarian Device Exemption pertains to devices aimed at rare conditions, allowing for a specialized pathway similar to orphan drug regulations.
Regulatory Pathways and Combination Products
- The 510(k) submission allows for substantial equivalence claims for combination drug/device products.
- The Office of Combination Products plays a vital role in determining the classification and regulatory pathway for innovative products.
- Understanding whether to follow US Title 21 regulations or ICH guidelines is essential for maintaining compliance during clinical trials.
Key Considerations in Clinical Research
- Informed consent forms must be culturally sensitive and translated appropriately when conducting research in diverse settings.
- Regulatory compliance in clinical trials emphasizes safety and ethical considerations, particularly when dealing with vulnerable populations.
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Description
Test your knowledge with flashcards focused on medical device regulations and the International Conference on Harmonisation. Each card contains key terms and their definitions, helping to reinforce your understanding of regulatory pathways and standards in the medical field.
