FDA Regulation and Approval of Medical Devices
Public health protection and promotion is becoming a new concern nowadays. FDA needs to do the evaluation and have a proper understanding about the evidence available in relation to the related products. As in case of medical devices, The evidence is mostly composed of non-clinical, and for some clinical facts have been conducted and the medical sponsor provides it to the FDA. Now, the FDA regulation studies that the real world data wealth which is covering all of these medical experience that exists and is normally collected in the term of management & treatment of the patients. The data that is collected, during the home setting process or in clinical care may not match with the quality controls as compared to the collection of clinical trial setting. Due to some conditions, the real world data can be of sufficient quality to check and respond or simply argument FDA’s knowing, of the different benefit risk devices at numerous points of their whole life cy...