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Guidance for Industry and FDA Staff - Food and Drug Administration - fda

Guidance for Industry and FDA Staff - Food and Drug Administration - fda 2025

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The document provides guidance from the FDA regarding the Mammography Quality Standards Act (MQSA), detailing requirements for mammography facility surveys, equipment evaluations, and medical physicist qualifications. It updates previous guidance issued in 2000 and outlines the responsibilities of medical physicists, including conducting annual surveys and evaluations of mammography equipment to ensure compliance with quality standards. The document also specifies the qualifications needed for medical physicists, including education, training, and continuing education requirements.

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Is FDA guidance mandatory?

In general, FDAs guidance documents do not establish legally enforceable responsibilities and thus are not binding on FDA or the public. Instead, guidances describe the Agencys current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

What is the difference between FDA regulations and guidance?

Guidance documents must not set new legal standards or impose new requirements. Unlike regulations, guidance documents do not contain amendments to the Code of Federal Regulations and are not subject to the notice and comment process. Are FDA Guidance Document Law? No.

What is guidance for industry in the FDA?

FDA uses guidance documents to explain the Agencys current thinking on such matters as the design, manufacturing, and testing of regulated products; scientific issues; content and evaluation of applications for product approvals; and inspection and enforcement policies.

What is the difference between FDA guidance and FDA regulations?

Guidance documents represent the Agencys current thinking on a particular subject. Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts.

What is the purpose of the guidance document?

A guidance document is a statement of general applicability issued by an agency to inform the public of its policies or legal interpretations.

What is guidance for companies?

Guidance is a companys own best estimates to shareholders of its upcoming earnings. It is usually published immediately after earnings for the past quarter and is the focus of discussion at a meeting between company executives and analysts.

Guidance for Industry and FDA Staff - Food and Drug Administration - fda 2025

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