When we visit the doctor, most of us don’t think twice about the quality of the devices our doctors and caregivers offer us. After all, critical medical devices that keep people alive go through a rigorous testing process, right? That’s not always the case according to an alarming study published in the Archives of Internal Medicine.
For manufacturers to gain FDA approval for critical medical devices, including implants and life-sustaining devices, they must submit the product to one of two approval processes.
One is a stringent premarket approval (PMA) process that involves clinical trials and thorough manufacturing inspections. Alternatively, they can submit devices to the 501(k) process, a simpler process without human studies or manufacturing scrutiny.
The startling study focused on high-risk devices, a third of them cardiovascular devices, recalled between 2005 and 2009. Of the 113 devices studied, 80 were approved through the 501(k) process and 8 completely skipped the approval process because the FDA determined them too low-risk to test.
Facing significant 2012 budget cuts, the FDA lacks the workforce and funds to test each critical medical device to PMA guidelines. In contrast with the $4,007 price tag for 510(k) approval, manufacturers pay a $200,000 fee for premarket approval, which is only a quarter of what the FDA spends testing.
Amidst congressional scrutiny of the approved defective medical and industry concerns about the effects of changes to the 510(k) system, the FDA commissioned the Institute of Medicine to review the 510(k) process. The administration is currently reviewing the report, which was completed in April, and is expected to announce changes to the approval process this fall.
What changes do you think the FDA should make to their approval process?
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