Is it time to revamp the FDA approval process of medical devices?

In the past couple of years, quite a few medical devices have either been recalled or come under scrutiny after reports of patients being seriously injured or killed due to a defective device. In the case of DePuy’s artificial hip implant, Johnson & Johnson’s surgical mesh product for pelvic organ prolapse (POP) and the Myxo ETIlogix annuloplasty ring, these devices were approved by the FDA through the 510(k) process which allows new medical devices to come to market through a nominal premarket approval process.

Now, the U.S. Institute of Medicine, a non-governmental non-profit organization which provides unbiased and authoritative advice on science, medical and health issues, is calling for a complete overhaul of the FDA process for approving new medical devices.

A medical device can be a simple tool like a thermometer, bandage or complex such as pace-makers, artificial hips or MRI machines. The FDA is responsible for ensuring that a medical devices have a “reasonable assurance of safety and effectiveness” before it can come onto market. Devices that may pose some risk to patients must be cleared through the Section 510(K) process.

The 510(k) process is a “fast track” through FDA approval and allows manufacturers to claim that a new device is substantially equivalent to other devices and therefore do not require expensive medical scrutiny and clinical trials. In the case of the DePuy hip implant that was recalled, the design was of significant departure from previous hip implant designs but was still given market clearance.

The Archives of Internal Medicine published a study that found that medical devices that resulted in serious patient injury or death were more likely to have been approved by the FDA through the 510(k) process.

On July 29, 2011, the U.S. Institute of Medicine published the results of a study of the FDA approval process which found that the 510(k) process is flawed and rather than trying to fix it, the FDA should develop “an integrated premarket and post market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” (Read the Press Release, “FDA Should Invest in Developing a New Regulatory Framework To Replace Flawed 510(k) Medical Device Clearance Process“)

Pressure is on the FDA to change the approval of medical devices but also to put in place a system in which problems with the devices are tracked and patient symptoms noted.

Hopefully, the FDA will move forward with insuring patient safety from defective medical devices.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who have been seriously injured by defective medical devices and through medical malpractice.

Related Posts:

FDA considers revising medical device approval process

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