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Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress
A proposal to keep potentially flawed medical devices from entering the market made its way to the Food and Drug Administration this week, with two congressmen asking the agency to reform its approval process for new devices that are modeled after existing, but later recalled, products.
In a letter addressed to the head of the FDA’s Center for Devices and Radiological Health, Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR) say the current process used to fast-track such devices, known as 510(k), “opens the door for defective devices to make their way onto the market and jeopardize patient safety.”
The lawmakers suggest the process itself is flawed because it essentially requires regulators to approve a new product without clinical trial data if its manufacturer can show it is similar to an already legally marketed device – a “predicate” – but says nothing of how the agency should act when the predicate has been found to be defective.
“Already, thousands of patients have been harmed — in some cases grievously and irrevocably — by medical devices that were modeled after recalled devices,” the letter states.
The current law, displaying a peculiar lack of hindsight, virtually guarantees that the FDA will clear new products proven to be sufficiently similar to ones already approved, even in cases when they contain the same design flaws that have prompted recalls of the latter.
The danger in approving medical devices through the expedited process is due not only to the fact that the evaluations don’t factor in safety concerns matched to the original product, but also because they don’t require clinical testing in humans, thus doubling the potential risk of failure.
The congressmen say the FDA’s authority should be expanded to allow it to reject a device if its blueprint contains the same likelihood for malfunction that led to the recall of an earlier product. In the meantime, they are asking the agency to update its 510(k) database to reflect which new devices have been cleared despite being based on a model that was later found to be defective.
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