Report Calls for Overhaul of Outdated FDA 510(k) Approval Process

Many defective medical devices, dangerous drugs approved by outdated 510(k) process

A FDA approval process called 510(k) meant to help expedite new drugs and medical devices to market may instead cause patients more harm because it fails to ensure products are safe for consumer use, according to a study by the Institute of Medicine.

FDA officials requested the Institute of Medicine, an independent organization, review the process in response to widespread recalls of medical devices including 90,000 DePuy ASR Hip Implants last summer.

The 501(K) clearance process allows a drug or a medical device to be cleared for consumer distribution provided it’s considered a “moderate-risk device” that is similar to any previously cleared 510(k) product or a product that was grandfathered in under the Medical Device Amendments of 1976, 1990, and 1997.

The committee has recommended that the process is flawed and be completely overhauled.

“The committee finds that the current 510(k) process is flawed based on its legislative foundation,” said the IOM report. “Rather than continuing to modify the 35-year-old process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and post market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

Decades of legislative fine-tuning has turned the 501(k) process into a loop hole. Products are being marketed as safe for consumer use when they’re not.

The problem comes from the fact that some of the “predicate” products were on the market before the Medical Device Amendments of 1976, 1990 and 1997 were passed, meaning that they were never systematically assessed for safety and effectiveness themselves, according to the study.

For example, in 2005 DePuy Hip Implants received FDA approval through the 501(k) process, even though the new implant used metal-on-metal components recycled from a different kind of hip device. After hundreds of thousands of items had been sold, it was discovered that the metal-on-metal components caused serious side effects that caused a higher than expected revision rate.

Another defective product that was reviewed under the 510(k) process is transvaginal surgical mesh, used to treat pelvic organ prolapse and stress urinary incontinence. The FDA has received thousands of reports of serious side effects which have become the subject of possible lawsuits.

If you have had a DePuy ASR Hip Implant or undergone POP surgery using transvaginal surgical mesh and would like additional information about the safety concerns regarding these defective medical devices, contact our experienced pharmaceutical attorneys today for additional information by calling 877-318-0580 toll free or filling out our online contact form.

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