CSMS # 58378189 – Food and Drug Administration (FDA) End-Dating Center for Devices and Radiological Health (CDRH) Product Codes The Food and Drug Administration (FDA) will be end-dating the Center for Devices and Radiological Health (CDRH) product codes listed below. The end-date will be in 30 days, December 13, 2023. Product Code/Description 78L[][]ST/Device, Erectile Dysfunction […]
Category Archives: FDA
Please note the following guidance released today by FDA regarding MoCRA: November 8, 2023 Today, the U.S. Food and Drug Administration (FDA) issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure […]
November 2, 2023 Today, the U.S. Food and Drug Administration (FDA) proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. This action is part of our regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns. Brominated vegetable oil (BVO) is a vegetable oil that is modified […]
November 1, 2023Today, the U.S. Food and Drug Administration (FDA) is providing an update on ongoing activities related to the new cosmetic product facility registration and cosmetic product listing mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).In August 2023, FDA issued draft guidance on cosmetic product facility registrations and product listings. FDA received more than […]
FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. This will help the respondent organize their registration and listing submission to include the […]
Constituent Updates Center for Food Safety and Applied Nutrition View on the FDA Website July 24, 2023 The U.S. Food and Drug Administration (FDA) will reopen the comment period for the 30-day procedural notice to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods” that appeared in the Federal Register on June […]