IU Kelley expert: Overhaul of FDA's approval process for medical devices overdue, but balanced approached needed


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    George Ball

The Food and Drug Administration has announced plans to overhaul its system for approving a certain category of medical devices, which critics have said fails to protect consumers from risky implants and medical instruments.

George Ball, assistant professor of operations and decision technologies and the ArcelorMittal Supply Chain Faculty Fellow, at the Indiana University Kelley School of Business, studies the medical device industry, in particular medical device recalls.

There are two primary approval pathways for medical devices. “510(k)” clearances are reserved for products that demonstrate substantial equivalence to a previously approved device. Clinical trials are normally not required and this method is much faster and cheaper than the other pathway, a “Pre-Market Approval (PMA).”

PMA new product submissions are reserved for those products that are new or substantially modified from previously approved devices. Clinical trials in humans and laboratory study data are normally required to demonstrate safety and efficacy. In comparison to 510(k) clearances, PMA approval pathways are time-consuming and expensive.

“The FDA’s announcement regarding an overhaul of the 510(k) approval process seems to be warranted, as medical device product approvals are currently on two ends of an extreme spectrum,” Ball said. “New PMA products can require years and millions of dollars to successfully obtain approval by the FDA. Conversely, 510(k) clearances are significantly faster and cheaper, as the manufacturer has to simply demonstrate equivalence with similar, already approved products.

“As 510(k) products represent the bulk of new product approvals, they also represent the bulk of medical device recalls, unsurprisingly,” Ball said. “In the last decade, 510(k) products were recalled at a ratio of 17-to-1, compared to PMA products.”

“However, the method of approval currently practiced for 510(k) products has many benefits for manufacturers as well,” he said. “Demonstrating equivalence with prior approved similar devices makes the development time exponentially faster compared to PMA product approval times.

“A middle-ground here seems logical and advisable. For example, the FDA approves products using a two-pronged approach: safety and efficacy. While efficacy may be easily established by demonstrating similarity to prior products, evidence of safety for 510(k) products may require additional verifications and tests. Doing so may help ensure that new 510(k) products, which are often much more technologically advanced than the ones they are compared against for approval purposes, are also safe for patients.”

Ball can be reached at 812-856-0625 or gpball@indiana.edu

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