Indeed, the medical devices are essential tools. They are intended, by their manufacturer, to be used for purposes common to medicines, such as: To prevent, Diagnose and treating a human disease. They must achieve their ends through mechanisms that do not translate into pharmacological, metabolic or immunological actions. And that is how they are distinguished from medicines.
A device for in vitro diagnosis is any medical device that consists of a reagent product, kit, instrument, device or system. In vitro diagnostic machine can be used combined or solo depending on the need of the patient (to collect samples from the patient’s body). It is done to obtain information about physiological states or states of health, from disease or congenital anomaly. The United States of America’s Food and Drug Administration, in short FDA Pre-Submission Program let the manufacturers (manufacturers of in vitro diagnostic and medical equipment) to decide particular aspects of the requirements and regulatory process with the FDA specialists. The program was previously known as Pre-IDE.
In vitro diagnostics and its role in health sector
Nowadays, almost 75% clinical (minor and major) decisions are taken on the results of in vitro tests. The diagnostic medical devices in vitro help physicians and laboratory professionals to make better decisions, both from a clinical point of view and from the point of view economic. Correct diagnoses generate optimized results with reduced costs, both for the patient and for the paying entity. Correct diagnoses are vital for proper and effective treatment.
From the Patients’ point of view – They prevent or delay problems, through screening for infections or predisposition to diseases. They prevent or delay complications of chronic diseases, by ensuring adequate levels of treatments with the respective medications. They prevent relapses and adverse effects, as well as reduce the length of hospital stay by monitoring appropriate therapies.
From the Clinical point of view – They allow a quick and reliable diagnosis, providing objective information and early detection of infections or complications. They improve the effectiveness of treatments, monitoring applied therapies and their effects. They allow the design of treatments tailored to the specific needs of patients, namely by providing them with the ability to self-control.
From an economic point of view – They reduce health expenses in the long run, ensuring accurate treatments and rational use of resources. Reduce health care spending by adjusting procedures and therapies. They reduce the economic burden of disease in society, by screening for infections and predisposition to diseases.
In short, FDA Pre-Submission Program is crucial and plays a great role in health care.