FDA has Revoked Three EUAs for Medical Devices that Detect/ Diagnosis COVID-19
In July and August of 2021, the Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorizations (EUAs) for Gravity Diagnostics, LLC for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America for the...
FDA’s New OTC Drug Facility User Fees Announced – OMUFA Fee Not Tied to Registration Renewal Season
In March of this year, the Center for Drug Evaluation and Research (CDER) branch of the Food and Drug Administration (FDA) implemented a new fee under the OTC Monograph User Fee Program (OMUFA). The fee was required of all facilities that produced OTC monograph drugs...
CDER Now Requiring Confirmation of U.S Agency for NDC Labeler Code Requests
Effective summer 2021, the Center for Drug Evaluation and Research (CDER) requires confirmation of U.S. Agency assignments for National Drug Code (NDC) drug labeler code requests submitted to the Food and Drug Administration (FDA). If the U.S. Agent has not been...
Pet Food Processors – Additional Enforcement Looming
The Food & Drug Administration (FDA) has begun to apply Import Alert 99-29, "Detention Without Physical Examination of All Vegetable Protein Products From China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs," to imported...
Registration Season is Coming! FDA has announced the Medical Device User Fees for Fiscal Year 2022
FDA has officially announced the updated medical device fees for the 2022 fiscal year (October 1, 2021 – September 30, 2022). All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait...
US Senators Introduce Bipartisan Legislation to Require Manufacturers of ENDS Products to Pay User Fees
On Friday, July 23rd, a bipartisan group of Senators introduced legislation that, if enacted, would require the manufacturers of e-cigarettes, vaping products, and other forms of electronic nicotine delivery systems (ENDS) to pay annual user fees to the Food and Drug...
Reconditioning Proposals for Adulterated Seafood: What FDA Wants to See
Our team has noted a recent and significant uptick in the Food and Drug Administration’s (FDA) enforcement with respect to seafood imports. Specifically, FDA has been heavily encouraging the use of the draft guidance document entitled “Reconditioning of Fish and...
FDA Expands Scope of Chinese Vegetable Protein Import Alert for Melamine
In 2012 FDAImports represented a Chinese primary vegetable protein processor to obtain the first Green Ticket from the Food and Drug Administration's (FDA) Import Alert (IA) #99-29. Since then, multiple other Chinese vegetable protein processors have obtained a Green...
FSVP Records Submission to FDA Now has a Portal on FURLS to Streamline Process
The Foreign Supplier Verification Program for Food Importers (FSVP) is one of the most significant Food Safety Modernization Act (FSMA) provisions and greatly impacted the food industry. On May 10, 2021, the Food and Drug Administration (FDA) opened a specific “FSVP...
Kratom-Navigating the Murky Regulatory Waters
On March 29, 2021, the Food and Drug Administration (FDA) updated and republished Import Alert 54-15, which allows for the detention without physical examination of dietary supplements containing Mitragyna Speciosa, otherwise known as Kratom. Kratom is a botanical...