FDA Reveals New Medical Device User Fees for Fiscal Year 2023
The U.S. Food and Drug Administration (FDA) has released the announcement of rates for Fiscal Year (FY) 2023 under the Medical Device User Fee Amendments (MDUFA).
Introduction
The FDA, as the regulatory body for medical devices in the United States, plays a critical role in ensuring the safety and effectiveness of these products. As part of its functions, the FDA requires medical device establishments to pay fees to maintain their compliance status. In this sense, the FDA has revealed the new medical device user rates for fiscal year 2023, which will go into effect from October 1, 2022 and will extend until September 30, 2023.
Medical device fees
Medical device user fees cover various aspects related to the regulation of these products. Among the required fees are medical device applications, periodic reports on class III devices, and annual establishment registration. These fees are essential to fund the FDA's activities in the oversight and control of medical devices.
Small business rates
In recognition of the needs and characteristics of small businesses, the FDA offers certain special considerations. If a business has total sales less than $100 million in the most recent fiscal year, it may qualify as a small business and get a reduced rate on applications. Additionally, companies with total sales less than $30 million may receive an exemption from first-time applications or premarket reports.
Importantly, if a company qualified for a reduced or waived fee in FY 2022, it will need to resubmit its information during FDA renewal to continue to qualify and benefit from these special considerations.
Establishment registration
Establishment registration is an essential requirement for all medical device establishments, regardless of size. Each physical location that handles certain functions regarding medical devices must pay the establishment registration fee. Unlike small business rates in other categories, there are no exemptions or reductions for small establishments, businesses or groups.
Payment of the establishment registration fee must be made for each physical location that the company has. This ensures that all medical device facilities are properly registered and comply with FDA requirements.
Rate increase for fiscal year 2023
Compared to fiscal year 2022, medical device rates for fiscal year 2023 have seen an increase. The FDA has mentioned that this increase is due to taking into account inflation over the last year. It is important to take this increase into account when planning for the costs associated with submitting applications and maintaining establishment registration.
Fiscal Year 2023 MDUFA Rates
Below is a comparative table showing establishment application and registration rates for fiscal year 2022 and 2023:
| Rate Type | 2022 | 2023 |
| Annual Registration of Establishments | $5,546 | $6,493 |
| Application Fees | Standard | Small company |
| 510(k) | $12,745 | $3,186 |
| 513(g) | $5,061 | $2,530 |
| New Classification | $112,457 | $28,114 |
| PMA, PDP, PMR, BLA | $374,858 | $93,714 |
| Panel Track Extender | $281,143 | $70,286 |
| 180 day supplement | $56,229 | $14,057 |
| Real Time Supplement | $26,240 | $6,560 |
| BLA Efficacy Supplement | $374,858 | $93,714 |
| PMA Annual Report | $13,120 | $3,280 |
The FDA emphasizes that medical device registrations are not considered complete unless all required payments have been submitted. It is essential to meet payment obligations within the deadlines established by the FDA. If the FDA has not received payments by the December 31 deadline, the establishment may be removed from the FDA database, which will invalidate its registration. It is essential to ensure punctuality in the payment of fees to avoid unintended consequences.
Export Global Opportunity Support
To help establishments determine the fees they are subject to and facilitate payment to the FDA, Export Global Opportunity can assist them.
This specialized organization can provide guidance and support throughout the process of meeting payment obligations.
Export Global Opportunity has the knowledge and experience necessary to ensure that establishments comply with FDA requirements appropriately and in a timely manner.
The FDA has announced new medical device user fees for fiscal year 2024. These fees are critical to maintaining FDA compliance status and cover things like medical device applications, periodic reporting, and annual establishment registration.
It is important to keep in mind the special requirements and considerations for small businesses.
Likewise, the increase in rates for fiscal year 2023 and the consequences of not paying them are highlighted.
Export Global Opportunity can assist with the fee compliance and payment process.
The U.S. Food and Drug Administration (FDA) has released new medical device user fees that will be in effect during fiscal year 2023. These fees are necessary to maintain medical device establishments' compliance with the FDA and fund the agency's oversight and oversight activities.
It is important to note that rates have seen an increase compared to the previous fiscal year, which is due to inflation consideration.
In addition, special considerations have been established for small businesses, which may benefit from reduced rates or exemptions in certain circumstances.
