EMERGO SUMMARY OF KEY POINTS:

• 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.

New guidance from the US Food and Drug Administration explains how domestic and foreign medical device manufacturers may qualify as small businesses in order to pay reduced 2018 user fees for market applications such as 510(k) premarket notifications.

The new guidance coincides with the release of the FDA’s 2018 fiscal year user fees established by the Medical Device User Fee Act of 2017, or MDUFA IV. Most fees will increase by more than 30% from current rates starting October 1, 2017. Small-business user fees are significantly lower than standard fees; for example, the FDA’s 2018 standard fee for a 510(k) submission will total $10,566, versus $2,642 for applicants qualifying as small businesses.

(US FDA medical device registrants have until October 1, 2017 to submit market applications and pay lower 2017 fiscal year user fees.)

FDA’s general small-business eligibility requirements

Firms eligible for reduced small-business user fees must have $100 million or less in sales for the most recent tax year.

In order 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.

Qualification for US companies

US-based companies seeking to qualify for small-business user fees should submit the following materials to the FDA:

• FY 2018 MDUFA Small Business Qualification and Certification request form (Form FDA 3602; currently the FYE 2017 request form is found at this link)
• A copy of the applicant’s US federal income tax return for the most recent tax year
• Copies of tax returns for any of the firm’s US affiliates
• A certified Section III of Form 3602A for each of the firm’s affiliates not based in the US

Submissions will undergo a 60-calendar-day review by the FDA, 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.

Qualifications for foreign companies

Manufacturers based outside the US must follow a slightly different process for small-business user fee qualification:

• 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)
• 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
• Submit completed Form 3602A to the FDA for review
• 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

Following submission of all required documents, the FDA will review foreign applicants’ requests within 60 calendar days and notify firms in writing whether they qualify for 2018 small-business user fees.

Additional US medical device regulatory information:

• US FDA consulting services for medical device and IVD companies
• US FDA Establishment Registration and FURLS listing services
• US FDA medical device regulatory process chart
• Whitepaper: Early communication with the FDA