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

Records processed under FOIA Request # 20157899; Released by CDR on 02012016Questions? Contact FDA/CDR/ONE/DID at CDRHFOISTATUS×FDA.HHS.gov or 3017968118Records processed under FOIA Request # 20157899;

How to fill out determination of intended use

How to fill out determination of intended use

1. Start by obtaining the determination of intended use form from the relevant authority or organization.
2. Read the instructions provided with the form carefully to understand the requirements and guidelines.
3. Provide your personal details such as name, contact information, and any other required identification information.
4. Clearly specify the intended use of the product, service, or document for which you are filling out the form.
5. Include any supporting documentation or evidence that may be required to support your intended use.
6. Review the completed form to ensure all required information has been provided accurately.
7. Sign and date the form as per the instructions provided.
8. Submit the completed determination of intended use form to the designated authority or organization.
9. Keep a copy of the filled-out form for your records.

Who needs determination of intended use?

1. Determination of intended use is typically required by regulatory authorities, organizations, or institutions that have specific guidelines or policies in place regarding the use of certain products, services, or documents.
2. Individuals or businesses involved in industries such as healthcare, pharmaceuticals, medical devices, food production, and research often need to provide a determination of intended use.
3. It can also be required for legal purposes, contract negotiations, or any situation where defining the intended use is necessary to ensure compliance or clarity.

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What is determination of intended use?

The determination of intended use is a process of identifying the specific purpose or function for which a particular item or product is intended to be used.

Who is required to file determination of intended use?

The manufacturer or importer of a product is usually required to file the determination of intended use.

How to fill out determination of intended use?

To fill out a determination of intended use form, one must provide detailed information about the product, its intended use, and any relevant specifications.

What is the purpose of determination of intended use?

The purpose of determination of intended use is to ensure that products are used for their intended purposes and meet regulatory requirements.

What information must be reported on determination of intended use?

Information such as product description, intended use, product specifications, and any applicable regulations must be reported on the determination of intended use.