No More Crying Over Pacifiers: FDAImports.com Persuades FDA to Change ABI System
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May 15, 2012
Company News, Law & Regulatory, Medical Devices
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Tags: ABI, automated broker interface, FDA, FDA detention, FDA hold, medical device, pacifiers, regulations, submission, teething
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
