The Association of American Feed Control Officials (AAFCO) recently developed new Model Regulations for Pet Food and Specialty Pet Food. AAFCO model rules are used by most states as part of their charge to regulate the manufacture, sale, and distribution of animal...
Registration
Registration Season is Coming! FDA has announced the Medical Device User Fees for Fiscal Year 2024
FDA recently announced the updated medical device fees for the 2024 fiscal year (October 1, 2023 – September 30, 2024). All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait until the...
FDA Registration Renewal Season Opens Oct 1, 2023
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is...
FDA Cancels Food Facility Registrations for Failure to Comply with UFI Requirement by Final Deadline
During the 2020 biennial renewal period, FDA began requiring food facilities to include a unique facility identifier (UFI) on their registration. The required UFI must be a DUNS number obtained through third-party company Dun & Bradstreet. FDA extended this due...
Cosmetic Regulation (Finally) Modernized…at Least in the Coming Years
After several decades, the U.S. Food and Drug Administration (FDA) will soon be required to update its regulation of cosmetic products following the amendment to Chapter VI of the federal Food, Drug, and Cosmetic Act (FDCA) as a part of the “Modernization of Cosmetics...
Congress Reauthorizes Collection of User Fees for 2023
UPDATE:Breaking News: The Medical Device User Fees have just been announced for FY2023. The Annual Establishment Registration Fee is $6,493. Other fees are now listed and can be found...
FDA Announced Final UDI Compliance Dates for Class I & Unclassified Medical Devices
Over the past several years, the Food and Drug Administration (FDA) has been phasing in requirements for Unique Device Identifiers (UDI) to be displayed on various classes of medical devices. The UDI system identifies medical devices sold in the United States and is...
Update On DUNS Requirement for 2022 Food Facility Registrations
In October of 2020, the Food and Drug Administration (FDA) introduced the requirement for all food facility registrations to include a UFI (Unique Facility Identifier). Currently, FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs...
WARNING: FSVP Importers, Time is Running Out
Beginning July 24, 2022, consistent with 21 CFR 1.509(a), food importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. As an Importer, what does this mean for you and your operation? Simply...
Mandatory Product Listing For Dietary Supplements
The Food and Drug Administration (FDA) is getting closer to requiring manufacturers and distributors of dietary supplements to list their products on a public FDA electronic database. On Tuesday, June 14, 2022, the US Senate Committee on Health, Education, Labor, and...