FDA has jurisdiction over pacifiers - which become a medical device - only when they are intended for teething.
Glen Burnie, MD (PRWEB) May 16, 2012
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 were medical devices – otherwise why would the importer submit information to FDA? In turn, FDA would detain the entry alleging the pacifiers failed to comply with the medical device regulations. That’s no surprise, because they are not medical devices.
In the past, it could take an importer up to two months to get FDA to review the entry and release the pacifiers – all the while costing time and money. FDAImports.com successfully articulated this problem to FDA and persuaded them to change the system. Now an importer can simply disclaim FDA jurisdiction when importing pacifiers and avoid the unnecessary time and money costs previously associated with importing pacifiers.
FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact: Jon Barnes, (410) 220-2800 or pr(at)fdaimports(dot)com.