Reading Part B37

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Select the most appropriate answer from A, B, C.

First, check if the option is Mentioned is the paragraph and Question.
If it is not Mentioned, proceed to Eliminate that Option.
If you are not sure, apply our LONS Methods too.
Do not expect a 100% Correct Option. Choose the one with the strongest possibility.

Questions count: 1
Passing grade: 4
Time limit: 3 minutes
Number of allowed attempts: 5

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B37. The policy document tells us that the potential toxicity of a component is evaluated by:

Inclusion of Multiple Components For devices that include components with different lengths of contact, we recommend that any extract-based biocompatibility testing be conducted separately. If the components are combined into a single test article, this will dilute the amount of component materials being presented to the test system and may not accurately identify potentially toxic agents that would have been found if the components were tested separately. For example, we recommend testing implants separately from delivery systems or other kit components. For devices or device components that contain multiple materials with differing surface areas or differing exposure to the body, if one or more materials is new, it may also be necessary to test the new material components separately as well, to further understand the potential toxicity of this component. For example, for a catheter-based delivery system that contains a new balloon material, tests of the delivery system separate from the balloon may be necessary to ensure adequate assessment of each of the materials.

testing the component exclusively.

testing the exposure separately.

adequate assessment of the material.