Thursday, November 18, 2010

What Does the FDA do in a Recall?

(Exerpts I found of interest on the web.)

A medical device recall is an action on the part of the U.S. Food & Drug Administration to address problems with any medical device found to be in violation of FDA law due to defect, health risk, or both. A recall may mean any of the following singularly or in combination:

- The device in question requires an alteration, adjustment, or repair.
- An inspection of the device is in order.
- Use of the device should be discontinued.
- The patient with the device will require regular medical monitoring.

In most cases, the manufacturer, distributor, or other responsible party issues a recall voluntarily upon being informed that the device is in breach of FDA regulations. Legally, however, the FDA does have the authority to compel a recall if the company is not cooperative and patients are facing significant health risks or death. (Compulsory recalls are extremely rare.)

When a company does issue a recall, some or all of the following events take place:

- customers are made directly aware of the recall via letter and public notice,
- information is provided to aid in product identification and to minimize health risks,
- actions are taken to prevent the problem from happening again.

The FDA oversees the recall to ensure that the manufacturer:

- takes adequate steps to protect the public and to achieve legal compliance,
- takes the necessary precautions to prevent the occurrence of similar problems in the future.
There are three “classes” of recalls:
- Class I recalls are the most serious and the greatest efforts are made to notify customers and the public.
- Class II recalls generally address temporary or reversible problems. Customers, but not the public, receive notification.
- Class III recalls involve little danger but, because a violation of FDA law has occurred, customer notification is required.

For a full explanation of the laws governing medical devices and the mechanisms of reporting a device failure or problem (by both consumers and medical institutions), visit


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