FDA Small Business Determination (SBD) Support
Eligible medical device businesses may qualify for reduced US FDA user fees through the FDA's Small Business Determination (SBD) programme. Obtaining the appropriate determination can help qualifying companies understand whether reduced fees may be available for certain FDA submissions and regulatory activities.
Cosmetic Compliance Nest provides documentation and application-preparation support to help medical device businesses organise the information required for an FDA Small Business Determination request.
What Is FDA Small Business Determination?
The FDA Small Business Determination process allows eligible businesses to apply for recognition as a small business for applicable FDA user-fee purposes. Eligibility is assessed under FDA requirements, which may include financial information relating to the business and its affiliates, where applicable.
A small business determination does not automatically reduce every FDA fee. The applicable fee category, fiscal-year requirements and any separate submission-specific conditions must be checked before relying on a reduced fee.
What Does Our SBD Support Include?
- Eligibility information review: Initial review of your business details against the relevant FDA small business criteria.
- Application preparation support: Assistance organising the information needed for the SBD request.
- Company information checklist: Guidance on business identity, ownership and other relevant details that may be required.
- Financial documentation organisation: Help identifying and organising applicable financial information and supporting records.
- Affiliate information review: Consideration of relevant parent companies, subsidiaries or affiliates where required by FDA rules.
- Completeness review: A review of the prepared information for apparent omissions before submission.
- Submission guidance: General guidance on the applicable FDA process and next steps based on the request type.
Who May Benefit From an SBD Application?
- Small medical device manufacturers
- Medical device start-ups preparing for FDA submissions
- Companies planning applicable FDA regulatory activities with user fees
- Businesses seeking to determine whether they may qualify for reduced FDA user fees
- Companies reviewing their regulatory costs for an upcoming fiscal year
Potential Benefits of Small Business Determination
- Helps eligible businesses assess access to applicable reduced FDA user fees.
- Supports more informed regulatory budgeting and planning.
- Helps organise the information needed for an SBD request.
- May reduce certain eligible regulatory costs if the FDA grants the determination and the relevant fee rules permit the reduction.
Information You May Need to Provide
The documentation required depends on your business structure and the applicable FDA requirements. Information may include:
- Legal business name and contact details
- Business address and relevant registration information
- Ownership and affiliate details, where applicable
- Financial information for the relevant period
- Supporting records requested by the FDA for the applicable determination
- Information about the FDA activity or submission for which you are assessing fee eligibility
Our SBD Support Process
- Initial assessment: We review your company profile and understand your intended FDA regulatory activity.
- Document checklist: We identify the information and records that may be required for your application.
- Preparation: We help organise the relevant business and financial information for the request.
- Completeness review: We review the available documents for consistency and apparent missing information.
- Submission preparation: We provide guidance on the next steps for submitting the request through the applicable FDA process.
Important Considerations
- Eligibility depends on the FDA's applicable definitions and requirements.
- Parent companies, subsidiaries and other affiliates may affect the eligibility assessment.
- Financial information must be accurate, complete and supported by appropriate records.
- Determinations and fee benefits are subject to FDA review and applicable rules.
- Renewal or a new determination may be needed for a later fiscal year, depending on FDA requirements.
Frequently Asked Questions
For further information about service scope, required documents and the application process, please visit our dedicated FAQ page or contact Cosmetic Compliance Nest.
Request FDA Small Business Determination Support
Planning an FDA submission and want to assess whether your business may qualify for reduced user fees? Contact Cosmetic Compliance Nest to discuss your company structure, available documentation and SBD application-support requirements.
Important Disclaimer
This service provides administrative and documentation-preparation support only. Cosmetic Compliance Nest does not represent that any business will qualify for an FDA Small Business Determination or receive reduced fees. The FDA makes the determination under its applicable requirements. Fee eligibility, supporting documentation and submission procedures may change, so applicants should verify current requirements with official FDA resources. This service does not constitute legal, accounting or tax advice, and no approval or cost saving is guaranteed.