November 8, 2023, FDA announced that the enforcement date for cosmetic facility registration and product listing will be delayed until July 1, 2024. The announcement stated that this was "to provide regulated industry additional time to comply with these requirements." However, the guidance document itself [...]
As noted in a previous post, there are a number of new regulations that cosmetic companies must comply with by December 29, 2023 as part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The regulations that are effective at the end of 2023 [...]
The device industry in the US continues to wonder what will become of the 510(k) process. Senator John Kerry of Massachusetts has written a letter to FDA Commissioner Dr. Margaret Hamburg raising concerns that the medical device industry has over potential changes to the 510(k) [...]