The US Food & Drug Administration (FDA) is the federal agency responsible for protecting the public health by ensuring the safety, efficacy and security of drugs, biological products and medical devices. ASCs should take care that the drugs and devices used in procedures and prescribed to patients are compliant with the latest safety standards and recommendations. The FDA can also provide assistance in the event of a drug shortage. The following pages provide additional information on drug and device recalls, drug shortages and strategies that ASCs can use to address the opioid epidemic.
A recall is a method of removing or correcting products that are in violation of laws administered by the FDA. Recalls protect the public from products like drugs and medical devices that present a risk of injury or are otherwise defective.