March 28, 2023
Startups are always on the lookout for ways to cut costs while still achieving their goals. When it comes to medical device submissions, navigating the FDA's regulatory requirements can be daunting and expensive. Did you know that there is a program specifically designed to help small businesses save money? That's right – the FDA Small Business Determination Program could be your pathway to savings some funds! In this blog post, we'll explore some of the best strategies for leveraging this program and streamlining your medical device submission process, so you can focus on what really matters: bringing innovative products to market.
Introduction to the FDA Small Business Determination Program
The FDA Small Business Determination (SBD) program offers certain benefits to small businesses that are seeking to market their medical devices in the United States. CDRH's Small Business Program determines whether a business is qualified and certified as a "small business" and eligible for a reduced fee for some types of CDRH submissions that require a user fee.
In order to be eligible for the SBD program, a small business must meet the following criteria:
A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.
The FDA SBD program is a great way for small businesses to save money on regulatory costs associated with marketing their medical devices in the United States. For more information on how to leverage the SBD program, see FDA Guidance Medical Device User Fee Small Business Qualification and Certification
Benefits of Using the Small Business Determination Program for Medical Device Submissions
The SBD program allows small businesses to submit their medical devices for FDA review with reduced fees.
The application types eligible for a reduced small business fee are: Premarket Notifications (510(k)), De Novo requests, Premarket Applications (Premarket Approval Application [PMA], Biologics License Applications [BLA], Product Development Protocols [PDP]), Premarket Reports (PMR), PMA/BLA Supplements and PMA Annual Reports, and 513(g) requests for classification information.
To see the current FY2023 FDA review fees visit Medical Device User Fee Amendments (MDUFA), where you can see the standard review fee for a 510(k) Notification is $19,870. If you qualify as a small business the FDA review fee is reduced to $4,967. Similarly, the standard FDA review fee for a PMA is $441,547, whereas if you qualify as a small business it is reduced to $110,387.
In addition, a small businesses are eligible for a "first premarket application/report" fee waiver where the PMA review fee is $0, if the business/affiliate gross receipts or sales are no more than $30 million. The "first premarket application/report" is defined as the first PMA (including Modular PMA), BLA, PDP, or PMR received by the FDA from a business entity or any of its affiliates.
Importantly, the FDA establishment registration fee is not eligible for a reduced small business fee.
How to Apply and Submit Documents to Receive the Small Business Determination
To receive a SBD, you must first submit an application to the FDA. The application must include:
1. If you are located in the US, a completed and signed Form FDA 3602 “MDUFA SMALL BUSINESS CERTIFICATION REQUEST For a Business Headquartered in the United States” if you are located outside the US, or have any affiliates outside the US, a completed and signed Form FDA 3602A “MDUFA SMALL BUSINESS CERTIFICATION REQUEST For a Business Headquartered in the Outside the United States”
2. The name and address of the manufacturer requesting small business certification.
3. Your Organization ID number (Org ID). The Org ID uniquely identifies a business in the FDA User Fee Website. The Org ID is a system-generated number assigned to a new organization during the account creation process.
4. The name and address of the person who will serve as your primary contact with the FDA during the small business certification request.
5. A list of any affiliated businesses.
6. Documentation to support your small business status, includes most recent federal tax return. You should provide the complete, signed and dated U.S. Federal income tax returns for the most recent tax year for a U.S. business and all U.S. Affiliates.
The FDA will complete its review of the Small Business Certification Request within 60 calendar days. Upon completion of FDA’s review, they will send you a letter that indicates whether or not the business has been qualified as a small business.
Tips for Maximizing Savings When Using the Small Business Determination Program
The FDA Small Business Determination (SBD) program offers many benefits for small businesses, including reduced fees. Here are some tips for maximizing your savings when using the program:
1. Know the eligibility requirements. To be eligible for the SBD program, your business must have less than $100 million in gross receipts and sales. If you meet this criteria, you can save over 50% on FDA review fees.
2. Understand the submission process. Be sure to review the requirements and instructions on Form FDA 3602 and the FDA Guidance Medical Device User Fee Small Business Qualification and Certification to ensure that your application is complete and accurate.
3. Plan your small business designation application around your FDA submissions. A small business designation application is required every year for small businesses to ensure you still meet the eligibility requirements. FDA’s calendar year begins on October 1. So if you are planning a submission in October, be sure to submit your Small Business Designation Application before October 1st to get the application in FDA’s review queue so it does not hold up your premarket submission.
4. Be sure to have your most recent tax return available to include with submission of Form FDA 3602. FDA generally prefers prior year tax returns as evidence that you meet the eligibility criteria.
5. Utilize available resources. The FDA provides many resources to help small businesses navigate the regulatory process, including online tutorials, webinars, and publications. Be sure to take advantage of these resources to help reduce your costs and save time.
The FDA Small Business Determination Program is a great way for startup medical device companies to save money on their regulatory submissions. By taking advantage of this program, companies can reduce regulatory costs. With the right approach and understanding of the program’s requirements, startups can leverage it to maximize savings and still get their premarket submissions reviewed by FDA. For assistance submitting your Small Business Determination Application to FDA, contact Folio Consulting Group, LLC today. We have helped countless small businesses successfully apply and get their FDA Small Business Certification from FDA.