FDA seeks industry opinions on expedited device approval process

The Institute of Medicine (IOM) recommended this week that the Food and Drug Administration (FDA) do away with its expedited approval process for moderate-risk medical devices such as artificial hips, but the FDA says it will seek more industry opinions before following that advice. Two years ago, the federal agency called on IOM to make recommendations on improving its 510(k) process, which is designed to get moderate-risk devices on the market faster. The IOM is an independent, nonprofit institute that provides information and advice on issues concerning health and sciences.

Under the 35-year-old 510(k) program, devices can move swiftly through the FDA’s approval process if they are determined to be sufficiently similar to comparable products that have been previously cleared by the FDA or were on the market prior to 1975, when the 510(k) process was first put in place. Many of these devices do not have to go through clinical trials, during which many problems are identified before the FDA decides whether to approve the product for mass distribution.

The program has come under fire in recent years from critics who say the accelerated program puts medical devices on the market before they have been thoroughly tested for safety. They point to recent recalls of devices that were approved though this process but failed to work as expected and caused injury to patients, such as the DePuy Orthopaedics hip replacement system.

IOM, acting as an independent body, recommended the process be overhauled in order to ensure patient safety. However, the FDA reported earlier this week that it would seek opinions from med-tech industry experts, the people and companies who develop devices and would benefit most from the FDA continuing its 510(k) program.

Source: Star Tribune