FDA Announces Opening of FY2027 MDUFA Small Business Determination Window
The U.S. Food and Drug Administration (FDA) has published updated operational timelines and requirements for its Medical Device User Fee Amendments (MDUFA) Small Business Determination (SBD) Program.
The Agency confirmed that the application window for Fiscal Year 2026 (FY2026) Small Business Requests (SBR) will formally close on August 1, 2026, at 4:00 PM ET. The application window for Fiscal Year 2027 (FY2027) will open one minute later, on August 1, 2026, at 4:01 PM ET. Submissions uploaded before or after these exact deadlines will not be processed for the respective fiscal year.
Purpose and Scope of the SBD Program
Managed by the Center for Devices and Radiological Health (CDRH), the Small Business Determination Program is designed to reduce the financial barrier for small- and medium-sized enterprises (SMEs) seeking U.S. market access for innovative medical devices.
Qualifying as a "small business" allows medical device developers to pay significantly reduced user fees for eligible premarket submissions, or in certain high-impact cases, receive complete fee waivers.
Because standard FDA user fees for premarket notifications (510(k)), De Novo requests, and Premarket Approvals (PMA) represent substantial capital expenditures, obtaining SBD qualification prior to submitting applications is a cornerstone of regulatory budgeting.
Eligibility Criteria and Reduced User Fee Categories
Eligibility for the SBD program is determined strictly by the combined financial records of the applicant entity and all of its global affiliates (including parent companies, subsidiaries, and joint ventures):
Standard Small Business Discount ($100 Million Threshold): Businesses with combined gross sales or receipts of $100 million or less for the most recent tax year qualify for reduced user fees across most CDRH application types.
Eligible Submission Types: Reduced fees apply to Premarket Notifications (510(k)), De Novo classification requests, Premarket Approvals (PMA), Biologics License Applications (BLA), Product Development Protocols (PDP), Premarket Reports (PMR), PMA/BLA supplements, PMA annual reports, 30-day notices, and 513(g) Requests for Information.
First PMA/BLA Fee Waiver ($30 Million Threshold): Entities with combined gross sales or receipts of $30 million or less are eligible for a 100% fee waiver for their first PMA, BLA, PDP, or PMR submission received by the FDA.
Registration Fee Exemption Limitations: The annual medical device establishment registration fee is generally excluded from small business discounts. A waiver of registration fees is restricted solely to entities earning $1 million or less that demonstrate severe financial hardship and have proof of prior-year registration payment.
Mandatory Electronic Submission and Documentation Requirements
In accordance with CDRH modernization mandates, all Small Business Requests must be submitted electronically via the CDRH Portal. Paper submissions or email requests are no longer accepted.
Applicants preparing an FY2027 SBR must execute a structured 6-step workflow:
Complete Form FDA 3602N: Prepare the standardized Small Business Request form electronically.
Gather Certified Tax Records: Provide certified U.S. Federal income tax returns for the most recent tax year. For foreign businesses without U.S. tax filings, certification must be obtained from the appropriate National Taxing Authority alongside Form FDA 3602N.
Identify Affiliated Entities: Disclose all domestic and international affiliates. Failure to include foreign parent companies or subsidiaries constitutes grounds for application denial.
Submit via CDRH Portal: Upload the completed Form FDA 3602N and tax certifications through the portal starting August 1, 2026, at 4:01 PM ET.
Track Review Status: Monitor the CDRH Portal dashboard for real-world processing updates and automated FDA notifications.
There is no submission fee charged by the FDA for processing a Small Business Request.
Strategic Timing and Planning Considerations
Small Business Determinations expire at the end of each FDA fiscal year (September 30). Consequently, SBD approvals granted for FY2027 will remain valid from October 1, 2026, through September 30, 2027.
Sponsors should note that SBD status is not retroactive. To benefit from reduced rates, a company must receive its official Small Business Determination approval decision from the FDA before paying the MDUFA user fee and submitting the corresponding premarket application.
Impact on Medical Device Manufacturers and Startups
For biotechnology startups, healthtech innovators, and international medical device exporters planning FDA submissions in late 2026 or 2027, the FY2027 SBD window opening provides a critical opportunity to optimize regulatory capital.
Manufacturers should focus on:
Auditing corporate structure to identify all domestic and foreign affiliated entities;
Securing certified tax documentation for the most recent completed tax year;
Aligning submission timelines so that SBR approval precedes premarket application filing;
Utilizing the CDRH Portal early after the August 1 opening to avoid submission bottlenecks;
Verifying that 510(k), De Novo, or PMA budgets reflect the specific small business fee tiers for FY2027.
By securing SBD status early in the fiscal cycle, device developers can dramatically lower regulatory filing costs and allocate financial resources toward clinical validation and commercialization.
