- The US FDA has published new guidance explaining how companies should apply to qualify for small-business medical device user fees instead of much higher standard fees.
- Generally, companies must have no more than $100 million in sales to qualify for the FDA’s small business user fee program.
- The guidance includes separate requirements for US-based and foreign medical device market applicants.
To qualify for small-business status, a manufacturer must submit a FY 2018 Small Business Qualification and Certification request to the FDA no later than September 30, 2018. Firms that prefer to do so may obtain small-business certification before submitting a medical device application that requires user fee payment. The content of the qualification request to FDA is provided in the table here bellow.
| Qualification for US companies | Qualifications for foreign companies |
| · FY 2018 MDUFA Small Business Qualification and Certification request form (Form FDA 3602) | · Complete Sections I and II of FY 2018 MDUFA Foreign Small Business Qualification and Certification, for a Business Headquartered Outside the United States (Form 3602A) |
| · A copy of the applicant’s US federal income tax return for the most recent tax year | · Generate an Organization ID Number (Org ID) and include it in Form 3602A
· Submit Form 3602A to your national taxing authority; the authority must then complete Section III of the form and return it to you |
| · Copies of tax returns for any of the firm’s US affiliates | · Submit completed Form 3602A to the FDA for review |
| · A certified Section III of Form 3602A for each of the firm’s affiliates not based in the US | · An additional Form 3602A Section III must be completed for any foreign affiliate of your company as well; income tax returns must be provided for any US-based affiliate you have |
- It will take 60-calendar-day for FDA to review the qualification request, after which the agency will notify the applicant in writing whether they qualify as a small business. Qualified firms will receive a Small Business Decision number, which should be provided in each instance where the firm seeks a small-business user fee discount.