How Does The FDA Administer Medical Device Recalls?

A recall is the process of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Medical device recalls are initiated one of two ways: In most cases, a manufacturer, distributor, or otherwise responsible party voluntarily recalls a medical device without any direction from the FDA. When a company takes notice that one of its products violates FDA law, it typically acts in two ways:

• The company initiates a recall and corrects or removes the product.
• The company notifies the FDA.

With its legal authority, the FDA may order a company to involuntarily recall a device. This may occur if a company refuses to recall a device that is allegedly associated with significant health problems or fatalities. However, in the last several decades, the FDA has rarely needed to require any company to recall a medical device.

Upon receiving notification of a company’s correction or removal action, the FDA:

• reviews the strategy proposed by the business entity to address the issue;
• assesses the health hazard posed by the product;
• determines if the company has violated FDA law and requirements, and, if appropriate;
• classifies the recall to indicate the relative degree of risk or the severity of injuries posed by the device.

A recall may be classified as follows:

• Class I: A situation where there is a reasonable chance that a product will cause serious health problems or death.
• Class II: A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death. The majority of recalls are in the class II category.
• Class III: A situation where a product is unlikely to cause any health problem or injury.

Once it classifies a recall, the FDA monitors it to ensure that the violating company’s recall strategy has worked effectively as proposed. The FDA only terminates a recall after it is assured that a product is no longer a health hazard and in violation of federal law.

When a company initiates a correction or removal action, the FDA posts notice of the action and any other relevant information in the Medical Device Recall Database. The FDA updates this database upon classifying and terminating the recall.

The FDA regularly posts private press releases and other public notices related to product recalls, market withdrawals, and safety alerts that may potentially present significant risks to consumers or users. After a recall has been classified, the FDA publishes a further notice in its Enforcement Report released weekly.

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