Understand FDA Post-market Safety Evaluations

The U.S. Food and Drug Administration (FDA) use a rigorous process to test pharmaceutical products, food products, and medical devices to ensure that they are safe for widespread public use. The agency must analyze clinical trials, laboratory tests, and a variety of experimental modalities to ensure that these products present no hazard for human use. The products are then approved for use by the public. However, the FDA continues to monitor products even after they are on the market to investigate problems that may not be foreseen in initial testing.

Post-market Evaluation of Products

Starting at 18 months after the initial approval, scientists at the FDA begin reviewing data associated with these new products. They use many different data sources to evaluate the item, including the pre-approval safety information, the FDA-approved label, any “adverse events” that may be caused by the product, adverse vaccine effects reports, safety reports produced by the manufacturer, medication use databases, and information from clinical trials or studies done after the initial approval.

Relevant information is then compiled and analyzed to determine if problems with the product are significant and chronic. In some cases, the outcomes may only affect a small number of people or may not be related to the product itself. In other cases, the FDA may find that re-labeling, alterations in how the product is used, or other changes are necessary to protect the safety and health of the public. Sometimes, the FDA becomes aware of serious and unexpected safety problems with products.

First Alert of Safety Problems

The FDA often becomes aware of product problems through a number of conduits. The agency may be contacted by the company that makes the product. The FDA may find a manufacturing problem during an inspection and may halt production or request a recall. Other official reporting agencies, such as the Centers for Disease Control, may alert the FDA to a problem.

Alerting the Public

The FDA then utilizes media outlets to alert the public to the risk of problems with certain products, devices or procedures. After evaluation of the information, the FDA may issue a recall of the product.

  • Class I Recall – this designation is used when the product could cause serious medical problems or even death.
  • Class II Recall – the FDA uses this designation to recall a product that may cause temporary medical problems or only has a slight risk of creating a problem.
  • Class III Recall – this designation is generally used when a product or device is not likely to cause health problems but is in violation of established manufacturing or labeling requirements.