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IVD

Question tag: IVD 40 Questions

0 Votes 1 Ans

Can investigational IVD studies receive expedited review (see Glossary for definition) by an IRB?

definition Expedited glossary investigational IRB IVD review

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Are there different goals for IVD studies compared to other device studies?

device different goals IVD

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What regulations apply regarding human subject protection in investigational IVD studies?

Human investigational IVD regulations Subject

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What information should the protocol include to ensure that the investigational IVD study will be scientifically sound?

ensure investigational IVD Protocol scientifically sound study

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What is the purpose of this guidance document and how does it differ from other guidance documents related to IVD products?

differ DOCUMENT documents guidance IVD products purpose

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Is there a regulation that specifically addresses labeling of IVD products?

addresses IVD labeling products regulation

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Which regulations contain provisions relevant to the IVD industry?

contain Industry IVD regulations relevant

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Can an unapproved or uncleared investigational IVD device ever be used for non-emergency treatment of patients who do not meet the inclusion criteria of an investigational study?

device investigational IVD meet non-emergency Patients treatment unapproved uncleared Used

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What records should help to ensure scientific soundness of an IVD investigational study?

ensure help investigational IVD records scientific soundness study

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Can an investigational IVD device be used outside of the study protocol, in an emergency situation?

device emergency investigational IVD outside Protocol study Used

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Can my IVD device be considered a humanitarian use device (HUD) and can I apply for marketing approval through a humanitarian device exemption (HDE)?

Approval device hde HUD Humanitarian IVD Marketing

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Can published literature be used to support an IVD premarket submission?

IVD Literature premarket published submission support Used

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When does an IVD study involve human subjects?

Human involve IVD study Subjects

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Is it appropriate to use a quality systems approach in the conduct of IVD studies?

approach appropriate conduct IVD quality SYSTEMS

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What regulations describe the content requirements for IVD premarket submissions?

content IVD premarket regulations requirements submissions

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Can an IVD device qualify for HUD designation if the affected patient population is fewer than 4,000 per year but each patient may need to be tested multiple times?

affected device fewer HUD IVD patient population qualify

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Can data from studies performed outside of the United States ( U.S.) be used to support an IVD premarket submission?

Data IVD outside Performed premarket support united states Used

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How do IVD devices differ from other devices?

Devices differ IVD

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What are Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs)?

GMPs good IVD manufacturing practices qsrs quality regulation regulations system