What is intended use of medical device?

What is intended use of medical device?

Definition of the term intended use (of medical devices) The actual medical purpose, that is, which disease or injury you can diagnose, treat or monitor. The authorised use, including the intended use, but also other planned actions of the user with this medical device such as storage, transport, update or cleaning.

What is an indication for a medical device?

Next comes indications for use. This is defined by the FDA as, “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”.

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 intended use of a product?

The intended use of the product refers to its normal use by end-users or consumers. The HACCP team must specify where the product will be sold, as well as the target group, especially if it happens to be a sensitive portion of the population (i.e. elderly, immune-suppressed, pregnant women and infants).

What is the difference between intended use and intended purpose?

‘intended use’: The MDR defines ‘intended purpose’, but not ‘intended use’. ‘intended use’ should be considered to have the same meaning as ‘intended purpose’. Thank you stealthdog.

What is the difference between indications and uses?

Intended use is all about what we say this device is to be used for, and indications for use is under what circumstances or under what conditions you would use that particular product.” – Mike Drues Mike Drues goes into what he calls “high level labeling” with tips on how to get your label to market with as few words …

What is the difference between intended purpose and intended use?

What Does not intended for use mean?

Not intended for public use means any area on or surrounding critical infrastructure that is either clearly marked as such or that a reasonable person would determine is not for public use. Criminal trespass in the second degree is a class A misdemeanor.

How does intended purpose relate to medical devices and information security?

The intended purpose helps one identify the clinical data that is relevant to the device, and the depth and extent of the clinical evaluation depend on the intended purpose (as well as on the classification, risks of the device, and the manufacturer’s claims in respect of the device).

What are product indications?

Product Indication means the clinical utility, intended use or clinical information of a particular Molecular Diagnostic Product, including, for example, the Product Indications identified in Appendices 1.5 and 1.10.

What is intended patient population?

The intended population is patients (or their surrogate decision-makers) with whom health care professionals can initiate specific and detailed conversations about goals of care considering current diagnosis, prognosis and treatment options (including the risk, benefits and alternatives of those options).

What are the indications of use for this product?

“Indications for Use” can be defined as “what circumstances or what conditions you would use that particular product or device.”2. Examples of this include the conditions the device was designed to diagnose, treat, prevent, cure, or mitigate, as well as a description of the target patient population.

What is the difference between intended use and indication of use?

Intended use is general usage of a medical product that you put on the label. Indication of use is specific reason why someone would use that device. Indication of use is the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population.

What is indication of use for medical devices?

Indication of use is the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population. If specific indication of use is not within general intended use then it requires reclassification and labeling changes via 510K.

Do your intended use statements get your medical device to market?

He’s the President of Vascular Science, consulting for medical devices and regulatory bodies like FDA, and he travels the globe to set everyone straight on medical device regulations. Your intended use and indications of use statements are integral to getting your medical device to market.

What are indindications for use?

Indications for use cover the reasons or situations in which someone would use the device. Under what conditions will the product be used? This is a term that is also commonly used in other areas, such as for classifying drugs and medications.