Medical device makers to pay more for product approvals

Medical device makers who want to have their products reviewed by the Food and Drug Administration (FDA) in order to be sold in the United States will have to pay twice as much as they have in years past. The agency says it is increasing its rates in order to pay for an additional 200 full-time employees to manage the approval process for moderate risk medical devices.

The vast majority of moderate risk medical devices are currently approved through an expedited process that grants approval to medical devices if there is a similar product already on the market. While this practice is designed to speed up the approval process, medical device manufacturers say they are often delayed by last minute questions about product safety.

Conversely, critics of the accelerated approval process say the practice allows devices on the market without clinical trials to flesh out safety and efficacy issues.

This expedited approval process has been widely criticized for allowing dangerous medical devices to be sold in the United States. One issue in particular are newer versions of artificial hips, which were made with all-metal parts. Traditional hip implants are made with plastic or ceramic parts.

The newer metal-on-metal devices were designed to be more durable, and were approved because they were similar to devices already on the market. However, the all-metal design proved to be dangerously defective. When the metal parts of the metal-on-metal implants rub together, bits of metal debris may fall into the joint space, which can cause inflammation. This can cause the loosening, fracturing or dislocating of the device.

The metal debris can also leech into the bloodstream, possibly causing a type of blood poisoning known as metallosis.

Reports of higher than expected failures of all-metal hip implants led the FDA to conduct a safety study of metal-on-metal hip implants.

The FDA fee increase must first be approved by Congress. Once in place, reviews of medical devices will include a follow up with device makers at the midway point to identify any emerging data on safety or efficacy issues.

Source: Business Week