Dollar, money

FY 2019 Medical Device User Fees Increase 4%

By MedTech Intelligence Staff
Dollar, money

The increase is significantly less than FY 2018, which saw user fees go up 33%.

This week FDA released the new figures for medical device user fees, annual establishment registration fees, and small business designation and fees for FY 2019 (October 1, 2018–September 30, 2019). The notice was posted on the Federal Register on July 30.

User fees, which will increase about 4%, go into effect on October 1. The agency requires user fees for many types of medical device submissions, including PMAs, 510(k)s, premarket reports, product development protocols (PDPs), premarket reports, annual reports for PMAs, PDPs, and PMRs, and De Novo classification requests. The fees are reduced for qualified small businesses, which fall into the category of $100 million or less in gross receipts or sales. If a business has gross receipts or sales of $30 million or less, the company is eligible for a fee waiver for its first PMA, PDP, PMR or biologics license application.

FY 2019 User Fees for Medical Device Submissions
Application Type Standard Fee ($ U.S.) Small Business Fee ($ U.S.)
510(k) 10,953 2,738
513(g) 4,349 2,175
PMA, PDP, PMR, BLA 322,147 80,537
De Novo classification request 96,644 24,161
Panel-track supplement 241,610 60,403
180-day supplement 48,322 12,081
Real-time supplement 22,550 5,638
BLA efficacy supplement 322,147 80,537
Annual report 11,275 2,819
30-day notice 5,154 2,577

All companies, regardless of size, must pay the annual establishment registration fee, which is $4,884 for FY 2019.

Related Articles

  • Hand holding globe - diversity

    “Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.

  • RQM plus logo

    Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.

  • Pixabay Globe

    The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current…

  • ISO_13485

    Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026.

About The Author

MedTech Intelligence