Big Savings For Small Businesses – Does Your Medical Device Company Qualify?

While very rewarding, it is no surprise that being an entrepreneur in the medical device industry will come with its own set of challenges. One of the hurdles you can expect to face is affording the costs associated with the FDA.  The FDA knows that these costs are a challenge for entrepreneurs trying to improve healthcare through innovation and has fee reductions for qualified small business under the Center for Devices and Radiological Health (CDRH). So, the question is, what do you have to do to be a classified as a “Small Business”?

The CDRH classifies a small business has a company with an annual revenue under $100 million in their most recent tax year. Companies under this annual revenue can be eligible for fee reductions when submitting the following items to the FDA:

Application Type Standard FeeSmall Business Fee
510(k)$12,745$3,186
513(g)$5,061$2,530
PMA, PDP, PMR, BLA$343,858$93,714
De Novo Classification Request$112,457$28,114
Panel-track Supplement$281,143$70,286
180-Day Supplement$56,229$14,057
Real-Time Supplement$26,240$6,560
BLA Efficacy Supplement$374,858$93,714
30-Day Notice$5,998$2,999
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)$13,120$3,280

Additional to these benefits, companies with a reported annual revenue under $30 million specialized in Class III medical devices, are also eligible for a “first premarket application/report” fee waiver.

So how do you apply for a Small Business Certification Request? Firstly, you’ll need to gather your U.S. Federal income tax return for the most recent fiscal tax year. Next, obtain your Organization ID number. This number is specific to your business and assigned to you when you register with the FDA. This number is not the same as your Federal Employer Identification Number or Taxpayer Identification Number. Following this step, download and complete the appropriate form for your business, Form FDA 3602 or Form FDA 3602A. Once all the sections required have been completed, you can mail a hard copy to the following address:

FY 20__ MDUFA Small Business Qualification
Small Business Certification Program
10903 New Hampshire Avenue
Building 66, Room 5305
Silver Spring, MD 20993
U.S.A.

Once received by the FDA, your application will be reviewed within 60 days of its arrival and a decision will be given to you on your business’ status. In our experience, the full turn around time from application receipt to the final status update is quite rapid and does not take a full 60 days. While this may be a confusing journey, the FDA offers several forms of aid to further assist and facilitate this process for you.

If you have any questions regarding this process, you can always contact the User Fees Help Desk at 301-796-7200 or send an email to userfees@fda.gov. In addition to these forms of contact, you can also visit the FDA Guidance Document for Medical Device User Fee Small Business Qualification and Certification at the following link.

If you are approved for your Small Business Application, the FDA will provide you with a start and end date of this business status. Make sure to reapply prior to your end date to keep your small business status up to date with the FDA and reap the benefits of being a Small Business!

Still unsure of this process? No worries, our PrimePath Medtech team is ready and happy to further assist and guide you through this process!