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Fda intended use statement example

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The document outlines the indications for use of the Endoret® Kit, a medical device designed for the rapid preparation of autologous platelet-rich plasma (PRP) from a small blood sample at the point of care. The PRP is intended to be mixed with bone grafts for orthopedic surgical applications. It includes details on regulatory compliance, device description, and its substantial equivalence to an existing system.

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What is a statement of intended use?

The Intended Use Statement is a short document that clearly outlines the devices intended purpose under the following headings: Intended medical indication: what specific medical conditions are you targeting, and what clinical claims are you making?

What is an example of intended use?

For example, a manufacturer may develop a medical device intended for use in the treatment of a specific medical condition, such as a cardiac pacemaker for the treatment of heart arrhythmias. The intended use of the pacemaker would be to regulate the patients heart rate and rhythm.

What is the purpose of an IFU?

indication, indication for use: refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. It should be distinguished from intended purpose/intended use, which describes the effect of a device.

What is the difference between IFU and user manual?

As mentioned above, an IFU is a procedure used to accomplish a specific task. These instructions can be contained in a user manual or as a standalone document. A notable example is the user manual is used to operate a medical device, while an IFU focuses on performing tasks on said medical device.

What is the difference between IFU and DFU?

Pharmaceutical Printed Booklets Overview CCL Healthcare offers a wide range of pharmaceutical-grade printed booklets that are specifically designed for Instructions for Use (IFU) and Directions for Use (DFU).

What is the difference between intended purpose and indications for use?

These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device.

What is the FDA statement of intended use?

Intended use is what you claim on your label that the device does. Its the purpose of your device. Indications for use are the circumstances or conditions under which the device will be used. These are the reasons you would use the device.

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