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Source: Wikimedia Commons, Scott5114, and RRY Publications, LLC

FDA 510(k) Clearances Fees to Double in 2018

Walter Eisner • Fri, September 1st, 2017

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It's going to cost device companies more than double what they paid for 510(k) Clearances in 2018 than in 2017.

In August, the U.S. Senate voted overwhelmingly to reauthorize the FDA's user fees agreement with medical device manufacturers for another five years. The President promptly signed the bill which called for an overall user fee increase of more than $320 million from the previous year. Now we've learned how those fees will be spread out for approvals, clearances and updates.

According to the FDA's website, 510(k) clearance fees will rise from $4,690 in 2017 to $10,566 in 2018. For PMAs (premarket approval) applications, a product development protocol (PDP) or a biologics license application (BLA), the fees will rise from $234,495 in 2017 to $310,764 in 2018.

There is also a new fee, that did not exist in prior years for de novo classification requests, which will run companies $93,017.

FDA User Fees / Source: FDA

The fees are less for small businesses. On August 28, 2017, the FDA issued a 39-page guidance for device companies in determining how to qualify and be certified as a small business. "This is defined as having gross receipts or sales of no more than $100 million for the most recent tax year," the guidance says.

In return for the higher cost, industry is being promised faster review times. For 510(k) products, the total time goal is currently 124 days. The new agreement lowers that goal by 13% to 108 days by the fifth year. For PMA products, the total time to decision goal is currently 385 days. The new agreement lowers that goal by 25% to 290 days by the fifth year.

As we reported back in August, the device industry's trade association, AdvaMed was happy. "Passage of this important legislation will enable FDA to continue its critical mission of ensuring safe and effective medical devices and diagnostics remain available to patients everywhere," stated a company press release.

“The robust FDA performance goals, process improvements, increased accountability and additional resources provided for under the new user fee agreement represent a victory for the agency, innovation and, most importantly, patients. The bill also includes pro-innovation provisions to improve the FDA inspections process and streamline device accessory classification."

Speaking in support of the legislation at a congressional hearing, AdvaMed President and CEO Scott Whitaker said the new agreement would lead to timelier patient access to devices.

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