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Reprinted from FDA's website by Acceptance and Filing Reviews for Premarket Approval Applications (PMA's) Guidance for Industry and Food and Drug Administration Staff Document issued on: December

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What is acceptance and filing reviews?

Acceptance and filing reviews are a process or mechanism to evaluate and review certain documents or forms to ensure compliance with regulations and guidelines.

Who is required to file acceptance and filing reviews?

The entities or individuals who are obligated by law or regulations to submit specific documents or forms are required to file acceptance and filing reviews.

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Acceptance and filing reviews can be filled out by providing accurate information and completing all the required fields as specified in the provided form or document.

What is the purpose of acceptance and filing reviews?

The purpose of acceptance and filing reviews is to assess the conformity of submitted documents or forms with legal requirements, standards, or criteria.

What information must be reported on acceptance and filing reviews?

The specific information that needs to be reported on acceptance and filing reviews varies depending on the nature of the documents or forms being reviewed. Generally, it includes relevant details such as identification information, dates, signatures, and any supporting evidence or documentation.

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