FDA: Request Small Business Status Before Submitting FY2017 Applications

Devicemakers seeking small business status for fiscal year 2017 should apply before submitting any product applications, a new FDA guidance advises.

Businesses with gross receipts or sales of $100 million or less for the most recent tax year qualify for a “significant reduction” in user fees, the FDA said. Those with $30 million or less qualify for a one-time waiver of the fee for their first-ever PMA application, BLA application, product development protocol or premarket report.

For fiscal 2017, the Premarket Application (PMA, BLA, PDP) fee for standard businesses is $234,495 while small businesses pay $58,624. The establishment registration fee remains the same for both small businesses and standard businesses (IDDM, Aug. 1).

Requests for small business status for fiscal 2017 must be submitted by Sept. 30. If the status is granted, it will expire Sept. 30, 2017. Devicemakers should submit a new MDUFA Small Business Qualification and Certification each year to qualify as a small business, the guidance advises.

For both U.S.-based and foreign applicants, the FDA will review the application and supporting documents within 60 days. If a business qualifies, the FDA’s decision letter will assign a Small Business Decision number that should be provided anytime a discount or waiver is sought.

U.S. businesses applying for small business status should submit:

• A completed Form FDA 3602 for FY 2017;
• A copy of their original federal income tax return for the most recent tax year;
• A separate federal income tax return for each U.S. affiliate; and
• A certified Section III of Form 3602A for each foreign affiliate.

Foreign businesses should take several steps in the following order:

• Complete Sections I and II of Form FDA 3602A for FY 2017;
• Submit Form FDA 3602A for FY 2017 to their national taxing authority, which completes Section III of that form;
• Receive the updated form back from the national taxing authority; and
• Submit the completed Form FDA 3602A to the FDA.

Companies with foreign affiliates should submit a separate certified Section III of Form FDA 3602A for each foreign affiliate. If the company has U.S. affiliates, it should send a U.S. federal income tax return for each of them.

The guidance is available at www.fdanews.com/08-04-16-smallbusiness.pdf. — April Hollis