• 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.

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