Medical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration Staff and Foreign Governments; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Medical Device User Fee Small Business Qualification and Determination Guidance." This guidance updates the previous version of the guidance, titled "Medical Device User Fee Small Business Qualification and Certification Guidance", issued on August 1, 2018. The guidance includes updates 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 details what information FDA intends to review and consider in making this determination.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.