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7.0 Analytical Studies: The statements and descriptions in the following sections refer to...

2023-10-03T05:22:57

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(b) the intended user (lay person or professional); (c) a general description of the princ...

2023-09-16T05:31:26

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Estimated patient exposure: This section of PSUR shall provide the estimates of the size a...

2023-07-08T06:49:34

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Analytical Studies: The statements and descriptions in the following sections refer to all...

2023-06-28T06:37:59

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Description and specification, including variants and accessories of the in vitro diagnost...

2023-06-27T05:11:45

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A PSUR should be structured as follows:— (a) Title Page: The title page of PSUR shall capt...

2023-05-29T09:13:40

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The device master file should include the following device descriptive information:— (a) i...

2023-05-20T06:48:45

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