Small Business Certification – FDA

Is your gross receipts or sales not more than $100 million for the most recent tax year? Is your added gross receipts or sales of your affiliates total is not more than $100 million??

Congratulations! You are qualified as “small business” under the FDA. You are eligible for a substantial reduction in the user fees for most types of medical device applications.

Now, follow the below steps.

Now strategize your plan to request the certification.

The FDA accepts Small Business Certification Request beginning August 1 prior to next FY starting on October 1. For example, requests for FY 2019 status (which runs from October 1, 2018, through September 30, 2019) will be accepted from August 1, 2018, through September 30, 2019.

Small Business Certification Request for the next FY received before August 1 will not be accepted.

After reviewing the tax documents and the FDA forms, ring the courier person!!!!!!

Now you are going to send these documents to the FDA @ the below address.

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

Here we are done. The clock starts for the FDA’s review of your Small Business Certification after its receipt.  Just within 60 calendar days, you get a letter that says your business has been qualified as a small business.

Hurry up!!! Get your application ready to file.  Go through the below board for the fees of the FY 2021 (October 1, 2020, through September 30, 2021)

 

MDUFA User Fees Structure – FY 2021

 

Application Type
Standard Fee
Small Business Fee
510(k)$12,432$3,108
513(g)$4,936$2,468
PMA, PDP, PMR, BLA$365,657$91,414
De Novo Classification Request$109,697$27,424
Panel-track Supplement$274,243$68,561
180-Day Supplement$54,849$13,712
Real-Time Supplement$25,596$6,399
BLA Efficacy Supplement$365,657$91,414
30-Day Notice$5,851$2,926
Annual Fee for Periodic
Reporting on a Class III device
(PMAs, PDPs, and PMRs)
$12,798$3,200

REFERENCES

Click on the below link to get more details on the Small Business Certification

FDA Guidance

Are you qualified as a small business and your gross receipts or sales are not more than $30 million?

Congratulations again!!

Your fee for your first premarket application/ reports ((i.e., PMA, including Modular PMA, BLA, PDP, or PMR) is waived off*.

*The “first premarket application/report” is defined as the FIRST PMA (including Modular PMA), BLA, PDP, or PMR received by FDA from a business entity or any of its affiliates. FDA determines that this is your first premarket application/report.

If you or any affiliate previously submitted a premarket application/report, then your next application does not qualify for the “first premarket application/report” fee waiver, and you must pay the fee that would otherwise apply.

Abrar Ahmed

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1 Comment

  • Tina Patil

    Hi,

    Where can I find MADUFA calendar by year such as all upcoming MADUFA in 2021, 2022?

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