FDA Approval of New Drugs & Medical Devices

The U.S. Food and Drug Administration (FDA) is the government agency responsible for protecting consumers by regulating medical products such as drugs and devices. Every year in the U.S., countless ideas for new drugs and medical devices are explored, but only a few will ever make it to market. 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 not approved by the FDA will be available in Europe or other parts of the world. This doesn’t necessarily mean the device or medication is unsafe. For a device to be used in Europe, it must have a CE marking, the abbreviation of the French phrase "Conformité Européene." This phrase translates into "European Conformity" and is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety, and environmental protection legislation.

Before a device or drug can be approved, it must be evaluated in scientific studies called clinical trials. Clinical trials are required to approve a drug or device in all parts of the world. The details of how a clinical trial is conducted can be different in individual countries. For that reason, products may be approved in other countries before they're approved in the U.S.

Accessing treatments before they’re FDA approved

You may want to ask your doctor if you’re eligible for treatments that become available prior to FDA approval. For example, suppose you have a disease or condition that affects fewer than 4,000 people per year. In that case, 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 the experimental device to be used in a clinical study to collect safety and effectiveness data. For more information about these exemptions and specific drugs and devices that may be available as treatment options, visit the FDA’s website.

Medications and devices considered novel—unlike therapies currently on the market—are subject to intense scrutiny in the form of clinical trials to ensure they’re 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 (CSDD) estimates the cost to bring a medicine from the testing stage to final market approval at $2.6 billion, and the process can often take 10 years or more.1