EMERGO SUMMARY OF KEY POINTS:

• US FDA has updated guidance for small-business certification in order to qualify for reduced medical device user fees for the 2019 fiscal year.
• A company must have no more than $100 million in sales for its most recent tax year in order to qualify for the FDA’s small-business designation.

US regulators have published updated guidance on how to qualify as a small business for discounted medical device user fees taking effect October 1, 2018.

The latest Food and Drug Administration guidance replaces similar guidance issued last year in conjunction with the agency’s 2018 fiscal year user fees. Small-business qualifications may be granted to US-based as well as foreign manufacturers applying for FDA registration.

Eligibility for small-business designation and reduced user fees

Qualifications for FDA designation as a small business and reduced medical device user fees have not changed substantially since the previous fiscal year. A manufacturer must have gross sales of $100 million or less for the most recent tax year in order to qualify for the program.

Small business certifications for the 2019 fiscal year begin October 1, 2018 and remain valid through September 30, 2019. FDA will accept small business certification requests from August 1, 2018 to September 30, 2019.

Application requirements for US companies

US-based medical device companies seeking FDA small business certification should submit Form FDA 3602; copies of their US income tax returns for their most recent tax year; separate copies of tax returns for any US-based affiliates; and Form FDA 3602A with certified Section IIIs for any foreign affiliates.

FDA has set 60-day timeframes for reviews of US small business certification requests.

Submission requirements for foreign companies

Companies based outside the US should complete Sections I and II of Form FDA 3602A, and then submit their forms to their appropriate national taxing authorities; said authorities must then complete Section III of the form and return to the company. (Separate Section IIIs must be completed for each affiliate of the applicant, as well.)

The applicant should then submit the completed Form FDA 3602A to FDA, which will review and determine qualification within 60 days.

Learn more about US FDA regulations for medical devices:

• US FDA medical device and IVD regulatory strategy
• FDA medical device Establishment Registration support
• FDA Agent Representation in-country representation