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.
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.
Just curious where in the US Constitution the Congress is authorized to create and fund the FDA?
I see someone wasn’t paying attention in Civic’s class. Article 1 — yes, the very first one — sets forth the powers of Congress to, among other things, pay the bills (all financial and budgetary matters) and to lay and collect taxes, duties, imposts and excises, to pay the debts and provide for the common defense and general welfare of the United States. The Constitution also grants Congress exclusively the power to appropriate funds. This power of the purse is one of Congress’ primary checks on the executive branch. That’s how Congress funds the FDA.
How was the FDA created? Congress created the FDA in 1906 by exercising its Constitutionally granted powers to provide for the general welfare of the United States. The 1906 law which created the FDA was the Pure Food and Drug Act.
Let me know if you have any other questions
Robin