Advisory panel calls for revamping FDA approval process for medical devices

[alp227]

Source: The Washington Post

An influential panel that advises the federal government on science policy proposed Friday that the Food and Drug Administration scrap the process it uses to clear many medical devices for use because the current method can’t ensure they are safe and effective.

The FDA should require more extensive testing of thousands of “moderate-risk devices” — from wheelchairs to artificial hips — that come to market with little study because manufacturers can argue that the devices are “substantially equivalent” to products already in use, the panel said.

A committee of 12 experts convened by the Institute of Medicine said the process allows a device to slowly evolve from its “substantially equivalent” ancestor without ever getting its own assessment for safety and effectiveness. Furthermore, many older devices that are basis for the comparison themselves were never fully tested.

“The public thinks that if the FDA clears and ‘approves’ a device that safety and effectiveness has been considered. But that is not always the case,” said David R. Challoner, a physician who headed the panel.

Read more: http://www.washingtonpost.com/national/health-science/advisory-panel-calls-for-revamping-fda-approval-process-for-medical-devices/2011/07/29/gIQAFGs9hI_singlePage.html

[a simple pattern]

1. That's interesting, thanks alp227.

I wonder who is on that panel, and what their connection is to Dow Chemical.

[Proletariatprincess]

2. Sounds like a positive story,

but like the last poster, I wonder who will benefit the most this. It should be the safety of the American people and it seems that is what it is. But...I have become so cynical it is hard to believe that.

[nebenaube]

4. Who benefits? The big boys...

This is a significant barrier to market entry and even a clipboard used in a hospital is subject to these regulations.

[Veracious]

3. FDA? Fuck that the "Tea LOL Party" abolished it.

Who needs safe drugs or food? WTH sounds progressive!!!