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Medical Device User Fees (MDUFA)MDUFA Fee Increases and FDA Small Business Certification

The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees for certain medical device applications, submissions, reporting on class III devices and fees for establishments subject to registration. These fees are in effect from October 1, 2017 through September 30, 2018.

2018 MDUFA Fees

FDA user fees have increased across all categories. This increase will substantially impact larger companies. Most FDA user fees increased 33%; however the standard application fee for a 510(k) submission rose 125% to $10,566. The increase in fees is a result of inflation adjustment plus any additional increase FDA feels is necessary to reach the inflation adjusted total revenue amount the agency has identified for the year.

Application Type2018 Standard Fees2018 Small Business Fees
510(k) premarket notification submission$10,566 (+125%)$2,642 (+13%)
513(g) request for classification information$4,195 (+33%)$2,098 (+33%)
Premarket application (PMA)$310,764 (+33%)$77, 691 (+33%)
De novo classification request$93,229 (new)$23,307 (new)
Annual fee for periodic reporting on a class III device$10,877 (+33%)$2,719 (+33%)
Annual establishment registration$4,624 (+37%)$4,624 (+37%)

Qualifying for Small Business User Fees

At the same time that the FDA announced their 2018 fees, they also updated their guidance FY 2018 Medical Device User Fee Small Business Qualification and Certification. A business that is qualified as a “small business” is eligible for reduced user fees. A small business must have no more than $100 million in gross sales for the most recent tax year. If your business is only submitting the annual establishment registration fee, you will not receive any reduction in cost, as indicated in the table above. The FDA asks that FY 2018 Small Business Qualification and Certification requests not be submitted in these cases.

MDUFA Small Business Certification Requirements for US Companies

If your company is headquartered in the US and wishes to become certified, you must:

MDUFA Small Business Certification Requirements for Non-US Companies

If your business is headquartered outside the US and does not file a US Federal tax return, you must:

What Happens After Submitting MDUFA Small Business Qualification to FDA

If you are intending to prepare a submission before 2017 is over, you will have to act fast to attain your small business certification. Your small business qualification submission will undergo a 60-calendar-day review. Then, a letter will be sent to your company identifying if your business qualifies, and you will receive a Small Business Decision number that will be needed when you pay qualifying user fees. Your company must be granted small business status prior to submitting a submission that requires a user fee. If an application is submitted before the FDA has awarded your small business status, the full standard fee will be required. FDA will not refund the difference. If you qualify as a small business, your status will expire on Sept 30, 2018. A new MDUFA Small Business Qualification and Certification should be sent to the FDA each year.

Helpful Information for Medical Device User Fees

When completing the form for Small Business Certification, the company will need an Organization ID Number. This number uniquely identifies the business with the FDA. Obtaining an ID number can be done here.

Answers to frequently asked questions about MDUFA can be found here.

 

Other FDA Medical Device Regulatory Support:

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