The Food and Drug Administration (FDA) requires registration of manufacturing warehousing facilities for most product categories under the agency’s jurisdiction. This is true for food, dietary supplement, pet food, animal feed, drug, medical device, and biologic facilities. The only exception is the cosmetic sector; registration [...]
The year 2020 started out ordinarily enough for the FDA Compliance Simplified team. We had projects related to foods, dietary supplements, over the counter drugs (OTC), pet foods, and medical devices. On March 2nd we received our first call regarding a project related to the new virus that was beginning to affect the United States.
Helping companies comply with FDA regulations is our specialty. But FDA is not the only regulatory body our clients need to be aware of. As our readers know, from time to time we invite other experts to provide other regulatory information essential to market success [...]
FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
2017 was a bit of a wild year with many twists and turns, stops and starts in the form of FDA actions. The agency once more delayed enforcement of restaurant menu labeling regulations; now set for May 7, 2018. The enforcement date for the revised [...]
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) [...]
The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. The Regulatory Flexibility Act of 1980 [...]
Hello! Last week the Food and Drug Administration and the Federal Communications Commission issued a joint statement regarding their intent to proactively address issues that arise when medical devices send patient information to physicians wirelessly. Issues such as the reliability and privacy of the communication [...]