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...
Seafood HACCP Implementation for Foreign Suppliers
The Food & Drug Administration’s (FDA) Hazard Analysis and Critical Control Points (HACCP) principles and practices started as a joint project between NASA and Pillsbury in the 1960s. The goal of HACCP was to ensure safe food for NASA’s astronaut program. Since...
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...
FDA Draft Guidance for Nonprescription Drugs Should Improve Labeling Consistency to Empower Consumer Choice
During the first full week of September, the Food & Drug Administration (FDA) released a draft guidance titled “Statement of Identity and Strength–Content and Format of Labeling for Human Nonprescription Drug Products.” This guidance outlines suggestions for...
MonkeyPox Declared as Public Health Emergency Medical Device companies Should Begin Preparing Now for EUA Submissions
The Biden administration has declared monkeypox to be a public health emergency in the United States. This is going to likely result in emergency use authorizations (EUAs) for medical products to diagnose and perhaps even reduce the symptoms related to the spreading...
FDA Calls on Companies to be “Recall Ready”…Are You?
On March 3, 2022, the U.S. Food & Drug Administration (FDA) issued a guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff,” to help companies prepare for voluntary recalls. Part 7 of Title 21 of the Code of...