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At FDAImports, we solve the problems involved in bringing products to the highly regulated U.S. market. Our team has over 100 years of direct FDA experience, helping manufacturers, distributors, importers and exporters of regulated products navigate the regulatory maze and successfully enter and stay in U.S. markets.
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The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) 2020 – Is your OTC Drug Company Ready?
On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of COVID-19. In addition to COVID-19 response efforts, the CARES Act includes new reforms intended to...
Beginning October 1, 2020, FDA will require a unique facility identification (UFI) number when registering food production facilities. Right now FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs for food facility registration. DUNS...
FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with the newly established Over-the-Counter Monograph User Fee Program (OMUFA), enacted as part of the...