Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance." The guidance includes select updates to the guidance "Medical Device User Fee Small Business Qualification and Certification" which describe how FDA plans to determine if a small business is experiencing "financial hardship" which makes them eligible for a waiver of their registration fee. The guidance will detail what information FDA will review and consider in making this determination. This draft guidance is not final nor is it for implementation at this time.