Regulatory Open Forum

Hi Akanksha,

A designated small business is eligible for a reduced fee for some types of CDRH submissions that require user fees.  Some examples are PMA, 510(k), De Novo, BLA.  To qualify as a small business the business, including any affiliates, must have gross receipts and sales of less than $100 million for the most recent tax year.  A small business is also eligible for a first premarket application/report fee waiver (PMA, BLA, PMR, PDP) if gross receipts or sales are no more than $30 million.

Getting qualified as a small business involves completing forms for your company and any affiliates - there are different forms and steps depending on if the company is foreign or in the USA.  As a foreign company, I had to submit the forms to be verified/authorized by our "National Taxing Authority" before I could submit them to FDA.  For USA companies, I believe you just submit a copy of the most recent tax return.

In my experience, what took the longest was getting the form/information authorized by our tax authority.  Once the completed forms got to the FDA it was processed within a couple of weeks.

The FDA released a guidance on small business qualification in 2018; please find it here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification

Hi Akanksha,

A designated small business is eligible for a reduced fee for some types of CDRH submissions that require user fees.  Some examples are PMA, 510(k), De Novo, BLA.  To qualify as a small business the business, including any affiliates, must have gross receipts and sales of less than $100 million for the most recent tax year.  A small business is also eligible for a first premarket application/report fee waiver (PMA, BLA, PMR, PDP) if gross receipts or sales are no more than $30 million.

Getting qualified as a small business involves completing forms for your company and any affiliates - there are different forms and steps depending on if the company is foreign or in the USA.  As a foreign company, I had to submit the forms to be verified/authorized by our "National Taxing Authority" before I could submit them to FDA.  For USA companies, I believe you just submit a copy of the most recent tax return.

In my experience, what took the longest was getting the form/information authorized by our tax authority.  Once the completed forms got to the FDA it was processed within a couple of weeks.

The FDA released a guidance on small business qualification in 2018; please find it here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification