FDA Medical Device Review Process Faces Scrutiny

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When a new product goes to market, consumers generally trust that the manufacturer has sufficient quality controls and safety processes in place to ensure that the product will not cause harm if used as intended.  If a defective design, flaw in the manufacturing process or failure to warn consumers of a potential risk of injury results in a customer or end user suffering serious injury or death, this could open the door to a product liability case.

Manufacturers of pharmaceutical products and medical devices are required to submit their products to a safety review process regulated by the U.S. Food and Drug Administration (FDA). It is the FDA’s responsibility to ensure these products are properly labeled with adequate warnings, and if used as directed, they will be safe and effective.

Does FDA Approval Guarantee the Safety of a Device?

A new report casts doubt on the effectiveness of the FDA’s regulatory framework.

According to the report in the Wall Street Journal, public safety evidence is severely lacking on a large percentage of FDA-approved medical devices that are on the market. In other words, the FDA may be putting its stamp of approval on many of these devices without enough data to sufficiently establish that these devices are effective and safe for use.

At issue is the 510(k) review process for moderate-to-high-risk medical devices such as metal-on-metal hip implants and transvaginal mesh implants. The process allows devices to be cleared and approved for the market if the manufacturer can present evidence that the device is “substantially equivalent” in safety and effectiveness to a device that is already on the market. The law requires that the manufacturer make this scientific evidence available to the public.

However, as the Wall Street Journal reports, a study recently published in JAMA Internal Medicine that looked at 50 medical devices approved through the 510(k) process found that the requisite scientific data was publicly available for only eight of the fifty devices that were approved, or 16 percent. This is not exactly the transparency the public expects from this agency.

Unfortunately, this is not a new problem. A little more than three years ago, the Institute of Medicine (IOM) conducted a study at the request of the FDA where it found the organization’s 510(k) review process to be inherently “flawed.”  The IOM recommended that a new process be put in place that would include more stringent pre-market and post-market regulatory features. As of this date, those changes have yet to be put into place.

Dangerous Medical Devices: Understanding Your Legal Rights

When medical devices are allowed to go to market without the proper testing and safety procedures in place, it poses a risk to those who use it.

Faulty testing, as well as the lack of an effective pre- and post-market review process, can lead to dangerously defective medical devices making it to market. This in turn could leave unsuspecting medical professionals and innocent patients facing terrible and unexpected consequences that could easily have been avoided.

If you believe that you or a loved one has been harmed by a defective medical device, it is important to speak with your physician as well as to meet with an attorney who can review your case. You have legal rights that deserve to be protected.

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