FDA Clearance and 2023 Medical Device User Fees – MDUFA

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The Medical Device User Fee or MDUFA is a funding source for the FDA.  As a medical device manufacturer, it is important to understand why you are paying this fee and what it will get you. The MDUFA cost is expected to change every year on or around October 1st. The fee medical device companies are required to pay is for the review and FDA decision when seeking premarket approval or 510(k) clearance to sell a medical device in the US marketplace. The process through which you receive clearance is the 510(k) process. A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate or legally marketed device. Below are some of the questions we are asked frequently regarding these fees.  These are summarized answers taken directly from the FDA website.  The link to the full content is located at the bottom of this post as well as the new MDUFA schedule.

User Fees Explained

The FDA collects fees from companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies. These fees are called “user fees.” The FDA collects user fees to supplement the funding they receive from Congress. User fees help the FDA fulfill its mission of protecting the public health. Every five years these fees are negotiated between the FDA and industry and then presented to Congress.  When Congress reauthorizes the legislation, the new fees are put into place

User Fees are Important to the FDA

The FDA has two types of funding.  The first is funding that Congress provides the agency and the second is user fees.  These fees help fund the FDA to ensure expected timelines during the review process and to allow for the staffing to review items and support agency programs.  An example of one of these activities would be the FDA’s role in helping to ensure safety for patients enrolled in clinical trials.

FDA process in determining user fees

There are separate user fees dependent on the type of product the FDA regulates.  User fee negotiations primarily involve the FDA and regulated industry the FDA also includes Congress and patient advocacy groups offering them the opportunity to provide input as well.

The FDA retains all decision-making authority regarding the marketing approval of medical products 

It is important to note that the FDA retains all decision-making authority regarding marketing approval of medical products regardless of the funding source. The FDA is committed to their mission and will not compromise their standards.  Public health is their focus and there is no connection/promise between the payment of a fee and clearance.  The fees are used to help fund the agencies costs.

There are restrictions on how the FDA may use fees for medical devices

For medical device user fees, funds can only be used for the process for the review of device applications, which includes monitoring of research, review of device applications, and a defined set of post-market activities.

The Third Party Review Group’s process provides the opportunity to move through the clearance program in 30 days

As part of the FDA’s commitment to their mission they created an expedited clearance program for low to moderate risk medical devices.  The Third Party Review Group [TPRG] has been accredited by the FDA to support this program.  In fact, TPRG has been in business working with and accredited by the FDA for 12 years; same owner, same review team, accredited to review over 1,500 product codes, supporting 14 device branches. That stability offers our clients a level of expertise that is unmatchable. Contact us now to see how we can help you!

» Click Here For FDA MDUFA Medical Fee Admendments

» Click Here For FDA MDUFA Pre-Market Submissions Fees