This post was contributed by FDAImports.com Regulatory Consultant, Walt Brittle Recently, Dan Starks, CEO of St. Jude Medical, Inc., announced to the media and investors that their Sylmar plant would likely receive a Warning Letter in response to an inspection...
This post was contributed by FDAImports.com Senior Regulatory Advisor, Tom Knott FDAImports.com recently saved a U.S importer of medical components the substantial cost of unnecessary laboratory testing for one of their products. When the U.S. Food and Drug...
The U.S. Food and Drug Administration (FDA) has extended the registration renewal deadline for medical device establishments from Dec. 31, 2012 to Jan. 31, 2013. In addition, FDA has been drastically overloaded and delayed in responding to communications from the...
If you distribute or import radiation-emitting electronic products, you may have already heard of FDA’s accession number system. However, we have found that many importers are perplexed when they are required complete Customs Form 2877 which, in part, asks the...
The U.S. Food and Drug Administration recently released a proposed rule that will require that most medical devices distributed in the United States carry a unique device identifier (“UDI”). A UDI is a unique code that is designed to allow anyone to identify the model...
If a labor dispute between U.S. seaport workers and port managers is not resolved before an impending September 30th deadline, then October 1 will represent more than the start of a new Federal Government Fiscal Year. It will also mark the start of a new import/export...
The FDAImports.com team is pleased to welcome Steven A. Johnson to our team! Mr. Johnson joins the firm as Principal, bringing nearly 20 years of FDA, Pharmaceutical, Biotech and Medical Device experience to the firm. He will be assisting clients with biotech and...
FDAImports.com achieved a major victory this month, making life easier for importers of pacifiers. The Automated Broker Interface utilized for making entry with U.S. Customs and Border Protection was originally set-up to force importers to notify and submit...
FDA recently issued new guidance regarding how FDA responds to device classification questions submitted under Section 513(g) of the Federal Food, Drug, and Cosmetic Act. In short, a 513(g) Request for Information must be submitted in writing to FDA, must be for a...
FDA’s quest for an increased budget and resources continues, as evidenced by its recently released FY 2013 Budget request. As FDA Commissioner Margaret Hamburg noted in her statement before the Committee on Appropriations, FDA believes that it’s bridging the gap...
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