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12501 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices shall provide such person a written statement of the classification (if any) of such device and the requirements of the FD&C
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Who needs revised guidance for industry?

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Regulatory bodies: Revised guidance for industry is designed to provide updated instructions, standards, or requirements to ensure regulatory compliance. Therefore, regulatory bodies such as government agencies, industry-specific authorities, or departments overseeing various sectors require this guidance.
02
Companies and organizations operating in regulated industries: Businesses operating in industries subject to regulations must follow the guidelines and standards set by regulatory bodies. Revised guidance for industry helps these companies stay informed about changes and updates relevant to their operations.
03
Professionals and practitioners in the field: Individuals working in specific industries, such as healthcare, manufacturing, pharmaceuticals, etc., rely on revised guidance to understand the best practices, safety protocols, or quality standards applicable to their work. Professionals in these fields need to stay updated with the latest guidance to ensure compliance and provide optimal services.
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Revised guidance for industry provides updated instructions and recommendations for businesses to follow.
All businesses operating in the specified industry are required to file revised guidance.
Revised guidance for industry can be filled out electronically through the designated online portal.
The purpose of revised guidance for industry is to ensure compliance with regulations and promote best practices within the industry.
Businesses must report relevant data, updates on procedures, and any changes in regulations that affect the industry.
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