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Guidance on industry and fda staff for bed rails

Guidance on industry and fda staff for bed rails 2026

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The document provides guidance on the qualification and certification process for small businesses seeking reduced medical device user fees under the FY 2016 Medical Device User Fee Amendments (MDUFA). It outlines eligibility criteria, fee schedules, and application procedures for both U.S. and foreign businesses, including necessary forms (FDA 3602 and FDA 3602A) and instructions for completion. The guidance emphasizes that qualifying as a small business can lead to significant fee reductions and potential waivers for first-time premarket applications.

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Click ‘Get Form’ to open the guidance document in the editor.
Begin by reviewing Section I, which requires you to provide the name of your business and its Federal Employer Identification Number (EIN). Ensure that this information matches your official documents.
In Section II, list any affiliates of your business. You will need to provide their names, Taxpayer ID Numbers, and gross receipts or sales figures. This is crucial for determining your eligibility as a small business.
Complete the certification section at the end of the form. This includes signing and dating the document, confirming that all information provided is accurate and complete.
Once completed, save your form and submit it along with any required supporting documentation to the FDA as outlined in the guidance.

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