Last week, the US Food and Drug Administration (FDA) released all of the updated user fees various regulated industries will need to pay to the agency in the coming 2014 fiscal year, including special exemptions for some medical device companies. Now FDA is out with a new guidance document meant to explain exactly which medical device companies are eligible for reduced rates, and how to determine eligibility.
Since the Medical Device User Fee Act (MDUFA) was first negotiated and passed into law in 2002, the medical device industry has, like its pharmaceutical counterparts, paid user fees to FDA to fund the agency's regulatory activities. The basic premise of the fees is that giving FDA more resources will allow it to hire more staff, who can in turn review applications more expeditiously. In return for the user fees, FDA also agrees to meet certain performance metrics for the review of applications, and to track its performance in a number of different areas.
Under the third and most recent iteration of MDUFA, also known as MDUFA III and passed under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, FDA agreed to establish two sets of fees for device companies: a standard fee, and a reduced fee for small business entities.
As evidenced below, the difference in fees can be substantial.
Medical Device User Fee Act (MDUFA)
Small Business Fee
Product Development Protocol
Biologics Licensing Application
510(k) Premarket Notification Submission
513(g) Request for Classification Information
Annual Fee for Class III Device
Annual Establishment Registration
As FDA explained in Federal Register, "If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA."
Guidance: How to Qualify
So how does a company qualify as a "small business for purposes of medical device fees?" While FDA's user fee notice in the Federal Register includes some language explaining the eligibility qualifications, the agency is also now out with a new guidance document meant to provide a clear answer to the question.
To be eligible for the small business fee, companies must have gross receipts or sales (including from all affiliated and subsidiaries) of no more than $100 million in the most recent tax year. This process requires filling out Form FDA 3602, MDUFA Small Business Qualification and Certification for a Business Headquartered in the US, which will be reviewed by FDA within 60 days of receipt. Attached to this form should be the company's most recent federal income tax return and the returns of any US or foreign affiliate.
Foreign companies will need to fill out Form FDA 3602A, MDUFA Small Business Qualification and Certification for a Business Headquartered Outside the US. Unlike US companies, foreign companies will need to submit the form to, and obtain certification from, their National Taxing Authority.
As shown in the table, small businesses are eligible for a vastly reduced fee. Not shown in the table, however, is an even more substantial benefit: Small businesses with sales less than $30 million per year which are filing a premarket application (PMA), product development protocol (PDP) or biologics license application (BLA) for the first time (i.e. their first-ever filing to FDA) are all eligible for a total waiver of user fees.
"FDA must determine that this is your first premarket application," the agency explains in its guidance. "Specifically, if you or any affiliate previously submitted a premarket application, then your next application does not qualify for the "first premarket application" fee waiver, and you must pay the fee that would otherwise apply."
Also of note: The annual establishment registration fee is not eligible for a reduced rate, but is the smallest of all levied fees at $3,313.
In addition, if an application is submitted to FDA before a company is qualified as a small business, the company should pay the standard fee rate. Importantly, FDA says it will not refund the difference if the company later qualifies as a small business. This means that smaller companies should take care to file for qualifying status early in the regulatory process or risk delays or a substantially higher filing fee.
All applicable forms are attached to FDA's guidance document, which may be found on its website.
Guidance for Industry and Food and Drug Administration Staff and Foreign Governments: FY 2014 Medical Device User Fee Small Business Qualification and Certification