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 extra MDUFA III requirements this year and is asking industry to allow two weeks for responses. FDA is also rolling out a new online registration and listing platform.

Background
The Food and Drug Administration Safety and Innovation Act (FDASIA), passed in July 2012, is intended to help increase … READ MORE

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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 information to FDA every time they brought in pacifiers. Only one problem: FDA has jurisdiction over pacifiers–which become a medical device–only when they are intended for teething.

This ABI setup, which forced an FDA submission, often caused FDA to hold the pacifiers under the mistaken belief the pacifiers … READ MORE

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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 single device, currently costs approximately $3,500 in (up front) user fees, and may take up to 60 days to process.  So what does one get for all that time and money?  In responding to … READ MORE

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