Get the free Determination of Intended Use for 510(k) Devices; Guidance - FDA

Records Processed under FOIA Request # 20158762; Released by CDR on 12082015DEPARTMENTOFHEALTH & HUMAN SERVICESPublic Health ServiceFoodandDrugAdministratio 9200Corporate Boulevard MD 20850 Rockville

How to fill out determination of intended use

How to fill out determination of intended use

1. To fill out the determination of intended use, follow these steps:
2. Begin by providing your personal details such as your name, contact information, and address.
3. Specify the product or service for which you are determining the intended use.
4. Describe the purpose or objective of using the product or service.
5. Provide any additional details or information required to support your intended use determination.
6. Sign and date the determination form to confirm its accuracy and completeness.
7. Submit the filled-out determination of intended use form to the relevant authority or organization as instructed.
8. Keep a copy of the completed form for your records.

Who needs determination of intended use?

1. There are various situations in which a determination of intended use may be required. Some examples include:
2. - Manufacturers or distributors who need to declare the intended use of their products
3. - Service providers who need to establish the intended use of their services
4. - Regulatory agencies or government bodies that require documentation of intended use for certain goods or services
5. - Researchers or scientists who need to specify the intended use of their experimental materials
6. - Healthcare professionals who need to determine the appropriate use of medical devices or medications
7. - Individuals applying for permits or licenses that necessitate demonstrating the intended use of a particular item or activity.

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What is determination of intended use?

The determination of intended use is a process that defines the specific purpose or function of a product or service.

Who is required to file determination of intended use?

Manufacturers, distributors, or importers of products or services are required to file determination of intended use.

How to fill out determination of intended use?

To fill out determination of intended use, one must provide detailed information about the product or service and its intended purpose.

What is the purpose of determination of intended use?

The purpose of determination of intended use is to ensure that products or services are used for their intended purposes and comply with regulations.

What information must be reported on determination of intended use?

Information such as product description, intended use, target market, and any limitations or restrictions must be reported on determination of intended use.