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FDA Re-evaluates Medical Device Safety Approval Process

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Gaithersburg, MDThe US Food and Drug Administration (FDA) is rethinking its process for evaluating medical device safety with a series of public meetings meant to weigh the pros and cons of its controversial fast-track approval process.

Since 1976, the FDA's 510(k) clearance process has allowed manufacturers to rush medical devices to market, provided that they are similar in form and function to already approved items. The procedure allows devices to enter the market without first undergoing clinical trials to test their safety and efficiency.

In recent years FDA approved medical devices have come under increased scrutiny due to numerous malfunctions in cardiac machines and leads. MedPage Today reports that more than 120,000 items have received approval through the process, and between 3,000 and 4,000 submissions are sent to the administration each year.

The National Research Center for Women and Families is conducting their own review of approximately 160 instances in which supposedly low-risk medical devices were recalled because they caused death or serious harm.

"If the 510(k) process is supposed to prove that products are reasonably safe and reasonably effective, it's failing," said Diana Zuckerman, the center's president.

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