When you are a medical patient, it is important to remember that you have a wide range of rights when receiving treatment. Along with state regulations, you also need to be aware of how regulations from the U.S. Food and Drug Administration may impact you regarding treatment and other related areas. As a patient, here are four FDA regulations of which you should always be aware.
Informed Consent
When you are participating in a clinical trial or undergoing any medical procedure, you as the patient have the right to informed consent. However, don’t mistake this for simply signing a standard consent form. Instead, informed consent refers to not only providing you as the patient with sufficient information, but also giving you enough time to think about it, and for you and your family to ask questions and have them answered in a satisfactory manner.
Confidentiality
FDA rules and regulations place a premium on patient confidentiality. For example, when participating in an FDA clinical trial, you as the patient will know your personal information will only be viewed by those who have an authorization, and that your medical information will be known only to you and the researchers involved in the study.
Pharmaceutical Drug Reviews
For any medication you are given or prescribed as a patient, FDA regulations require that the drug in question be manufactured based on existing FDA guidelines, undergo several review processes and quality control checks, and be properly evaluated through its testing in clinical trials. For businesses involved in pharmaceuticals, companies like Compliance Insight can assist with overseeing the regulatory process to ensure proper steps are taken from start to finish.
Medical Devices
From pacemakers and insulin pumps to various other types of medical devices, the FDA is responsible for ensuring all devices used with medical patients meet certain performance and safety standards. This process begins with product development, the developing of procedural guidelines, and continues through to device testing, validation of its performance, and quality control checks. Before you would have any medical device implanted within your body or used with you in any manner, you as the patient have the right to know the device has been thoroughly evaluated by the FDA, and to be given access to all pertinent information regarding its use and how it will impact your health.
As new treatments, drugs, and medical devices are introduced to patients each year, always be willing to assert your rights in treatment situations. Whether you ensure you have informed consent, know confidentiality will be recognized, or that the drugs or medical devices used in your treatment are safe, always use FDA regulations to your advantage.
