IOM recommends overhaul of FDA’s expedited medical device approval process

Moderate-risk medical devices such as artificial hips should be reliably screened by the Food and Drug Administration (FDA) for safety and effectiveness before those devices are marketed to doctors and patients, according to a new report by the Institute of Medicine (IOM).

The FDA currently approves these Class II devices under at 35-year-old process known as 510(k). This process was designed to get devices on the market faster. It can be used when new devices are determined to be sufficiently similar to comparable products that have been previously cleared or were on the market prior to 1975, when the 510(k) process was first put into place by legislative action. This process grants approval for about 3,000 products per year.

It seems safe enough to approve these much-needed devices quickly so they can be used by those who need them the most. But critics say this accelerated approval process puts medical devices on the market before they have been thoroughly tested for safety, and thus puts patients at risk.

One prime example is the DePuy Orthopaedics ASR hip replacement system. The hip implant was approved through the 510(k) process in 2006, but the devices soon began to fail at a higher than expected rate. It was also found that the metal-on-metal parts, originally thought to be stronger and more durable than the traditional ceramic parts, were flaking off bits as the metal parts rubbed together, causing a type of blood poisoning known as metallosis.

Reports of serious injuries from various devices approved through the accelerated process have forced the federal agency to review this expedited approval process. Two years ago the FDA sought the advice of IOM, which recently released its report with recommendations.

The report says that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one. Thus, the IOM is recommending that the FDA should invest in developing a new regulatory framework.

Source: The National Academies