• Food & Drug Administration (FDA) Approval of New Drugs & Devices


    Every year in the United States countless ideas for new medical devices and medication are explored, but only a few will ever make it to the U.S. Food and Drug Administration (FDA), the agency responsible for protecting consumers through the regulation of products such as drugs and medical devices. New medications and devices introduced for approval by the FDA must meet strict regulations, undergo intense scrutiny and are approved only when the FDA deems them “safe and effective when used as directed.”

    Sometimes a medication or device that is not approved by the FDA will be available in Europe or other parts of the world. This does not necessarily mean the device or medication is unsafe. For a device to be used in Europe it must have CE Marking. The letters “CE” are the abbreviation of French phrase "Conformité Européene," which means "European Conformity." A CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation

    Approval studies, often called clinical trials, are required for approval of a drug or device in all parts of the world. Different regulatory requirements in individual countries can lead to approval in certain countries prior to other countries.

    In the United States, the FDA regulates new medications and medical devices separately, but the process leading to approval, which delivers a new therapy from the laboratory to patient care, follows the same overall approach.

    If a new medication or device is similar to one already in use, then the research path will be shortened, or it will be less stringent than for a novel (new) medication or device. For instance, new medical devices go through a preliminary market approval (PMA) if they are brand new and unlike anything currently approved and in use (on the market). In contrast, if a new device is "substantially equivalent" to a device on the market, then it will go through what the FDA calls a 510(k) process in which clinical trials are typically not required and the FDA review process is often quicker.

    Accessing Treatments Before They Are FDA-Approved

    You may want to ask your doctor if you are eligible for treatments that become available prior to FDA approval. For example, if you have a disease or condition that affects fewer than 4,000 people per year, you may be eligible for a Humanitarian Device Exemption (HDE) or Humanitarian Use Device (HUD). Another exemption granted by the FDA for new devices is the Investigational Device Exemption (IDA), which allows for the experimental device to be used in a clinical study to collect safety and effectiveness data. Click here for more information about these exemptions and specific drugs and devices that may be available to you as treatment options.

    Medications and devices that are considered novel - unlike therapies currently on the market - are subject to intense scrutiny in the form of clinical trials to ensure they are both safe and effective. To get a sense of how intense the process for approval is, the Tufts Center for the Study of Drug Development estimates the cost to bring a medicine from the testing stage to final market approval at $802 million and the process can take five years or more.