What is the intended use of a 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 does uses or indications mean on the label?
Label indications vs. Medication that have label indications mean that they were approved by the FDA. This means that they are clinically significant for the indication and manufacturers are allowed to market their drug for the indication.
How do you define intended use?
How does the FDA define “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 activities are required to confirm that report meets its intended use?
Verification is the process of making sure that you have objective evidence that specified requirements are met. It is usually performed by tests, inspections, and in some cases analysis.
What are indications use?
“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 example of indication?
The definition of an indication is a hint, a sign or a symptom. When you frown, this is an example of an indication of unhappiness. A rash that develops after you eat a certain food is an example of an indication that you are allergic to the food.
What is indications for use FDA?
Indications for use for a device include 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. Any differences related to gender, race/ethnicity, etc.
What are verification requirements?
A verification requirement provides the rules of verification for a piece of data (verifiable data item). There are many variables included in these rules including where and how the rules apply at runtime.
How do you validate and verify requirements?
Verification can be done by:
- Logical argument.
- Modeling & Simulation.
- Expert Review.
- Test and Evaluation (T&E)
What is a new drug indication?
New indications are an early sign that a particular drug or procedure may be worth investing in further. For example, a company that has already obtained regulatory approval for a particular drug would report new indications if their research suggests that additional applications for that drug might be possible.
What is disease indication?
A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.
What is appropriate indication?
Appropriate indication was a sensitive indicator for abnormal endoscopic and histopathological abnormalities (85.2% and 90.1% respectively), but not specific (13.1% and 23.2% respectively) (Table 7). Serious side effects were not reported in any of the patients.