Medical device companies are waging a campaign to discredit the recommendations of the Institute of Medicine (IOM) that include doing away with the Food and Drug Administration (FDA) accelerated approval process for moderate-risk medical devices. IOM is an independent, nonprofit institute that provides information and advice on issues concerning health and sciences.
The FDA asked the institute more than two years ago to make recommendations on improving its 510(k) process, which is designed to get moderate-risk devices on the market faster. The process also greatly cuts down on the time it takes for medical device companies to begin selling and profiting from their products.
The expedited process has come under scrutiny over the years because some argue that many of these quickly approved devices are not adequately tested and may put patients’ health at risk. Critics point to recent recalls, including the DePuy Orthopaedics ASR hip replacement system.
The device was approved under the 510(k) process but shortly after it hit the market an unusually high number of failures were being reported with the hip implants. The company issued a recall last year. The FDA has since ordered a review of all similar, metal-on-metal hip replacement devices from various manufacturers to monitor safety issues.
Even before the IOM released its report recommending sweeping changes with the FDA’s 510(k) process, device producers released a series of their own reports arguing that altering the accelerated approval process would slow innovation, harm patients and cost jobs.
The FDA is currently reviewing the IOM report and any public comment on the expedited approval process. The FDA is not required to accept the institute’s recommendations.
Source: Seattle Times