FDA defines “small business” which includes all its affiliates with gross sales or earnings not exceeding $100 million, $30 million, or $1 million, for the most recent tax year, are eligible for small business fee waivers.
Qualified small businesses, with all affiliates with gross earnings of not more than $100 million are eligible for reduced fees for certain type of CDRH submissions that are required to pay user fee by the businesses.
Below are the application types that are eligible for reduced small business fees.
- Premarket Notification (510K)
- De Novo request
- Premarket Approval Application
- Biologics License Application (BLA)
- Product development Protocol (PDP)
- Premarket Reporting (PMR)
- PMA/BLA supplements and PMA annual reports
- 30-day-Notices
- 513(g) Requests for Information
Small business is eligible for “First premarket application/report” fee waives if the business and affiliate gross income are no more than $30 million for first their PMA, PDP, PMR, or BLA application.
FDA has introduced a new small business fee waiver program for MDUFA fees.
This fee waiver is not applicable for initial registration.
Companies are eligible for small business fee waivers if they satisfy all the requirements below.
- business, including its affiliates, has gross receipts or sales of $1 million or less in the most recent tax year,
- Must prove that paying the registration fee would represent a financial hardship (for example, proof your business is in active bankruptcy), and
- Proof that they had paid the registration fee in a prior fiscal year.
To apply for SBD, companies must get organization ID and submit form 3602N to FDA.
Liberty Management Group Ltd, as leading FDA consultants will provide assistance in creating user fee account, completing and checking form 3602N and providing assistance with Medical device establishment registration and renewals.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us