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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002 December 21, 2016,
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How to fill out indications for use statement:

01
Start by clearly stating the purpose of the product or service that the indications for use statement will be associated with.
02
Provide a brief description of the intended users or target audience for the product or service.
03
Specify the conditions or situations in which the product or service should be utilized.
04
Clearly outline any limitations or restrictions on the use of the product or service.
05
Include any necessary warnings or precautions that the users should be aware of.
06
Ensure that the language used in the statement is concise, specific, and easily understandable.
07
Review the statement for accuracy and completeness before finalizing it.

Who needs indications for use statement:

01
Manufacturers: They need indications for use statements to provide clear instructions to users about the intended purpose and proper use of their products.
02
Regulatory Agencies: These agencies require indications for use statements to assess the safety and effectiveness of a product or service.
03
Healthcare Professionals: They rely on indications for use statements to determine whether a product or service is suitable for their patients and to guide them in recommending or prescribing it.
04
Consumers: Indications for use statements help consumers understand how to properly use a product or service, ensuring effectiveness and minimizing risks.
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The indications for use statement describes the specific purpose or conditions for which a product is intended.
Manufacturers or distributors of medical devices are typically required to file indications for use statement with regulatory authorities.
Indications for use statement can be filled out by providing clear and concise information about the intended use of the product.
The purpose of indications for use statement is to ensure that the product is used safely and effectively for its intended purpose.
The indications for use statement must include details about the intended use of the product, including any limitations or restrictions.
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