FDA Steps Up Surveillance of Medical Devices
To Prevent Unforeseen Problems, Better Protect Patients

To reduce the number of unforeseen adverse events from medical device failure, the Food and Drug Administration today announced that it will require manufacturers of certain critical medical devices to conduct post-market surveillance of those products.

When necessary, firms will be required to gather data on the product's performance for up to three years to identify and evaluate, as early as possible, rare but potentially dangerous events that could endanger public health.

The new rule, published today in the Federal Register, will affect at most 30 medical devices a year. These include devices for which failure would be reasonably likely to have severe adverse health consequences; devices implanted into the body for more than one year; and devices that sustain or support life and are used outside a medical facility.

"Many problems or risks associated with a medical device cannot be predicted before the device enters commerce, even with clinical studies," said Dr. Lester Crawford, FDA Deputy Commissioner.

"Post-market surveillance will allow FDA and manufacturers to identify less common, but potentially serious, problems that were not evident during product development or to address problems that were not seen as serious enough to warrant keeping the product from reaching the market.

"Post-market surveillance will provide a way to evaluate these problems early and identify ways to minimize risk to patients, such as through physician training, device labeling or design modification," he said.

Manufacturers will be notified by FDA whenever the agency determines that post-market surveillance is necessary for a given device. This may occur during the review of a firm's marketing application, as the device goes to market, or after the device has been marketed for a period of time. Companies will be required to submit a post-market surveillance plan within 30 days of receiving an order.

Congress first instituted post-market surveillance of certain medical devices with the enactment of the Safe Medical Devices Act in 1990.

In the Food and Drug Administration Modernization Act in 1997 Congress modified this authority, giving the agency more discretion in imposing post-market surveillance and establishing a time limit.

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