Quick Answer: What Is An Intended Use Statement?

What is the meaning of intended use?

“Intended use is the objective intent of the persons legally responsible for the labeling of drugs.

The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.”.

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

So, simply put: Intended use = what you say on the label that the device is to be used for. Indications of use = the conditions or reasons for using the device. FDA wants you to be very “to the point” about your stated intended use on your 510(k) submissions.

What is an indication statement?

The statement should use high-level medical terms that are scientifically valid and recognized by health care providers. The indications statement details appropriate drug use per the study materials reviewed by the FDA. The drug must treat, prevent, mitigate, cure, relieve symptoms, or diagnose a disease state.

What are instructions for use?

Instructions for use: information provided by the manufacturer to inform the device user of the medical device’s intended purpose and proper use and of any precautions to be taken.

How do you use intended in a sentence?

The advertisements are intended to improve the company’s image.She was not the intended recipient of the reward.The bullet missed its intended target.His son is intended for the medical profession.It is not clear to us what you intended. … This movie is intended to revive her flagging career.More items…•

What is intended use in research?

The concept of intended uses moves from the general idea of doing a useful evaluation to a specific and concrete focus on the priorities of intended uses for a particular evaluation’s primary intended users. The goal of the evaluation then becomes intended uses by intended users.