FDASIA: FY 2013 Medical Device User Fee

This guidance explains how your business may qualify as a “small business” and pay most FY 2013 medical device user fees at substantially discounted rates; if you qualify as a small business, you may also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report).

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Your business may qualify as a small business if you reported “gross receipts or sales” of no more than $100 million for the most recent tax year. If you have any affiliates, you must add their gross receipts or sales to yours and the total must be no more than $100 million. Section I, Benefits of Qualifying as a Small Business, and Section V, Frequently-asked Questions, provide information of general applicability.

If your business is headquartered in the United States, you should follow the guidance in Section II, Guidance for U.S. Businesses, beginning at p. 8. You will complete an FY 2013 MDUFA Small Business Qualification and Certification, Form FDA 3602 (for FY 2013), and submit it to FDA for review; a copy of this form and instructions for its completion are provided in the Appendix. FDA will review your Small Business Qualification Certification within 60 days of receipt.

If your business is a foreign business headquartered outside the United States, you should follow the guidance in Section III, Guidance for Foreign Businesses, beginning at p. 10. To qualify as a small business, you should complete Section I and II of an FY 2013 MDUFA Foreign Small Business Qualification and Certification, Form FDA 3602A (for FY 2013), and submit it first to your National Taxing Authority (the equivalent of the U.S. Internal Revenue Service), and after the National Taxing Authority has returned the form to you with Section III completed (providing a National Taxing Authority Certification concerning your business), you should then submit the 3602A to FDA for review; a copy of this form and instructions for its completion are provided in the Appendix. You should also review Section IV, Guidance for Foreign Governments. — Preparation of a National Taxing Authority Certification, to understand the role played by your national taxing authority (particularly regarding Section III of the 3602A, which provides the National Taxing Authority Certification concerning the information you intend to submit to FDA). FDA will review your Small Business Qualification Certification within 60 days of receipt.

If you are a National Taxing Authority, you should review the guidance provided in Section IV, Guidance for Foreign Governments — Preparation of a National Taxing Authority Certification; you will complete Section III, National Taxing Authority Certification, of each 3602A submitted to you by a business headquartered in your nation, which you should return to the business seeking small business status.