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FDA Official: Uptick In PMA, 510(k) Applications Calls For More User Fee Dollars

The number of PMA and 510(k) applications have been steadily growing and becoming harder to review as they’ve become more complex – which an FDA official says means the agency needs more financial resources.

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The increasing complexity of Premarket Approval (PMA) and 510(k) applications over the years is putting a significant strain on the US Food and Drug Administration’s ability to meet its user-fee deadlines, an agency official familiar with the review process said. Without additional funding, the official predicts that the agency may not be able to keep up in coming years.

As the FDA negotiates with industry over the next iteration of the Medical Device User Fee Amendments (MDUFA V), an agency official spoke with Medtech Insight about how regulators have...

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