While Congress attempts to speed up the approval process for medical devices, a recent survey shows that the general public wants the opposite to happen. Results from a new Consumer Reports poll indicate that 82% of Americans think it's more important to adequately test medical devices for safety than get them on the market quickly. Despite public support for longer device testing periods, Congress is close to reauthorizing the Food and Drug Administration (FDA) law which allows the organization to waive clinical trials for a medical device that is substantially similar to products already on the market, even if some of those devices have been recalled for safety issues.
According to current laws, the 510(k) rule allows makers of medical devices to submit a premarket notification to the FDA, stating that the product they are developing is at least as safe and effective (substantially equivalent) as a device that is already being marketed to the public legally. The law was originally intended to speed up the approval process for devices that bore minimal risk to users, such as blood pressure cuffs. Unfortunately, the legal loophole has been stretched to include far more dangerous products, like the DePuy hip implant, with disastrous results.
Despite lack of public support and a proven track record of human injury, Congress is actually seeking to speed up the device approval process even further by making it easier to prove that a device meets 510(k) standards. Currently, less than one percent of medical devices actually go through the full FDA testing and approval process.
While there is some value in bringing potentially life-saving medical products to the market in a timely fashion, user safety should always be the primary concern. If you or someone you love has been injured by an unsafe medical device, you should speak with a medical injury lawyer at our firm, as you may be entitled to compensation. The medical injury attorneys at Arnold & Itkin have extensive experience representing clients with
defective medical device claims, and would be happy to advocate on your behalf.
Contact a medical injury attorney at our offices today for a free consultation regarding your case.