On July 28, 2023, the U.S. Food and Drug Administration (FDA) posted a Federal Register notice announcing the User Fees for Fiscal Year 2024. The fees have increased by 9.5% and will be effective October 1, 2024. You can find the new User Fees below.
Medical Device User Fee Rates for Fiscal Year 2024
Application Fee Type
FY 2024 Standard Fee
FY 2024 Small Business Fee
|Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))||$483,560||$120,890|
|Premarket report (submitted under section 515(c)(2) of the FD&C Act)||$483,560||$120,890|
|De novo classification request||$145,068||$36,267|
|510(k) premarket notification submission||$21,760||$5,440|
|513(g) request for classification information||$6,528||$3,264|
|Annual fee for periodic reporting on a class III device||$16,925||$4,231|
|Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding or processing of a device, as defined by 21 U.S.C. 379i(14))||$7,653||$7,653|
To view the notice on Federal Register, visit https://www.federalregister.gov/documents/2023/07/28/2023-15919/medical-device-user-fee-rates-for-fiscal-year-2024.
How Can NAMSA Help?
Navigating the FDA regulatory landscape can be overwhelming for any medical device manufacturer—not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving regulatory requirements, market success and accelerated timelines.
NAMSA is here to help. We are the industry leader in driving successful regulatory outcomes for medical device manufacturers. NAMSA’s regulatory team has completed numerous Q-Submissions. We maintain a strong relationship with the FDA and are able to provide communication and logistic resources.
If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please Contact Us, or learn more about our Regulatory Experts at namsa.com/subject-matter-experts.
Marcella Martin, MBA, RAC is a Senior Regulatory Consultant at NAMSA with over ten years’ experience working in regulatory affairs in the medical device and pharmaceutical industries. She has authored and managed a variety of submissions to FDA, Health Canada and notified bodies. These have included pre-submission, IDE, IND, technical file, master file, device license application, ANDA, Annual Report and vigilance reporting. She has completed regulatory assessments and regulatory strategies for products in development and for proposed changes to products already on the market. Marcella holds a Masters of Business Administration (MBA) degree from Colorado State University, Fort Collins and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).