FDA updates X-ray import rules

by Brendon Nafziger, DOTmed News Associate Editor | September 09, 2011
The Food and Drug Administration has released its latest updates for brokers and manufacturers importing diagnostic X-ray units and other radiation-emitting equipment.

In a letter published Sept 6., the agency advised import brokers and others receiving medical X-ray and other products from abroad to submit the proper Affirmation of Compliance codes. While doing so is voluntary, it could help expedite the admission process and reduce the likelihood that the FDA will hold the goods as part of its screening process, the agency said.

These updates follow a March 24 letter in which the FDA said it was concerned with the number of imported medical devices that lack "sufficient data entry" to allow them to be promptly admitted at their U.S. port of entry. The FDA said it has created new AofC codes and revised some old ones to speed the process along.
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To learn more and to see the updated codes, check out the Sept. 6 letter and the March 24 letter.

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