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Regulatory Requirements › Food and Drug Administration (FDA) › Small Business

Hogan Lovells

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

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On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous guidance document dated...more

Wiley Rein LLP

FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

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The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more

Hogan Lovells

FDA Announces Inspections of Small Businesses under FSMA Intentional Adulteration Rule to Begin March 2021

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The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will...more

Hogan Lovells

FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive...

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The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive...more

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