On 10 September 2026, the U.S. Food and Drug Administration (FDA) updated the Small Business Determination (SBD) program for medical devices. The update sets out the FY 2027 application schedule, the fee reduction and waiver benefits available, the electronic submission process, and the documentation required to support an application.
Source: FDA — Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program | www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program
1. FY 2027 Application Windows
The FDA updated guidance page carries an update date of 13 July 2026 and confirms both the closure of the FY 2026 window and the opening of the FY 2027 window.
| Item | Date or Requirement |
| FY 2026 application window | Closed on 1 August 2026 at 4:00 PM ET. Applications submitted after that time were not accepted for FY 2026. |
| FY 2027 application window | Opened on 1 August 2026 at 4:01 PM ET. |
The following key dates apply to the FY 2027 cycle:
| Item | Date or Requirement |
| FY 2027 application window opens | 1 August 2026, 16:01 (U.S. Eastern Time) |
| FY 2027 regular application period | 2 August 2026 to 1 August 2027 |
| FY 2027 annual establishment registration fee waiver period | 2 August 2026 to 1 November 2026 |
| FDA review target | Within 60 calendar days of receipt of the application |
| Fiscal year to which FY 2027 small business status applies | From 1 October 2026 or the later of the approval date, through 30 September 2027 |
2. Fee Reduction and Waiver Benefits
Three tiers of fee benefit are available under the SBD program:
| Benefit Tier | Revenue or Sales Threshold | Key Conditions | Applicability |
| Application or report fee reduction | Not more than USD 1 million | Total revenue or sales of the company and all affiliates in the most recent fiscal year does not exceed USD 1 million. | Not applicable to the annual establishment registration fee. |
| Waiver of fees for a first premarket application or report | Not more than USD 30 million | Revenue of the company and all affiliates meets the threshold, and none of them has previously submitted a first premarket application or report within the defined scope. | Applies only to PMA, PMR, PDP and BLA. Not applicable to 510(k). |
| Annual establishment registration fee waiver | Not more than USD 1 million | In addition to the revenue threshold, the company must demonstrate financial hardship and that it has previously paid an annual establishment registration fee and registered with the corresponding Owner/Operator Number. | The financial hardship circumstances currently listed by FDA are companies in bankruptcy proceedings. |
Qualification does not carry over. Small business status does not renew automatically. A company wishing to benefit from the reduced fees in the following fiscal year must submit a new application for each fiscal year.
3. Application Materials
A complete SBD application typically includes the following:
| Material | When Required |
| Form FDA 3602N | All applicant companies |
| Tax documents for the most recent fiscal year | To evidence the company’s revenue or sales |
| Tax documents for all affiliates | Where affiliates exist |
| National tax authority certification | Foreign companies or foreign affiliates, where required |
| Financial hardship documentation | When applying for the annual establishment registration fee waiver |
| Proof of previous annual establishment registration fee payment | When applying for the annual establishment registration fee waiver |
| Other supporting materials | For example certified translations and evidence of company name changes |
Foreign Companies
Foreign companies must declare both the local currency amount and the US dollar amount, and must state the exchange rate used.
Where no national tax authority exists in the jurisdiction in which the company is established, the company may submit annual financial statements, shareholder reports or other evidence of revenue, together with a declaration signed by an authorised officer of the company confirming that no such tax authority exists locally and that the information submitted is true and accurate. FDA will review each such submission on a case-by-case basis.
4. Online Submission Process
Electronic submission is mandatory. FDA confirms that all Small Business Requests (SBR) must be submitted electronically through the CDRH Portal. Applications submitted by post will not be accepted.
| Step | Key Content |
| Step 1 | Look up the company Organization Number (Org ID). Companies that already have a User Fee System account must not create a duplicate. |
| Step 2 | Prepare the tax and supporting materials for the company and all affiliates. |
| Step 3 | Complete Form FDA 3602N, including the national tax authority certification section where required. |
| Step 4 | Log in to the CDRH Portal, create a “Small Business Determination request” and upload the materials. |
| Step 5 | Monitor FDA email and Portal notifications. Where issues arise, FDA may request additional information. |
| Step 6 | Check the application status and the final determination in the CDRH Portal. |
5. Recommendations for Companies
- Recalculate revenue before applying. Confirm the revenue or sales of the company and all affiliates for the most recent fiscal year, and identify the applicable tier of fee reduction.
- File within the applicable window. The regular application period runs to 1 August 2027, but the annual establishment registration fee waiver period closes on 1 November 2026.
- Prepare the documentation early. Assemble tax documents, Form FDA 3602N and supporting materials, including national tax authority certification for foreign companies and financial hardship evidence where a registration fee waiver is sought.
- Reapply each fiscal year. Small business status is granted for the applicable fiscal year only and must be renewed in the next fiscal year.
- Allow for the review timeline. FDA targets a decision within 60 calendar days of receipt. Where a financial hardship claim is made, case-by-case review may extend the timeline.