FDA Publishes Final Electronic Registration Rule for Medical Device Manufacturers

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[author: Eric Johnston]

The U.S. Food and Drug Administration (FDA) published in the Federal Register on August 2, 2012 a final rule requiring medical device manufacturers to register their products electronically on the FDA Unified Registration and Listing System, or FURLS.  As part of the new rule, each medical device manufacturer, both foreign and domestic, will establish an account on the FDA’s online device establishment registration and device listing system, which will be used to update information regarding its medical device.  “The new electronic system will allow FDA to more effectively gather information concerning marketed devices,” the Federal Register posting states.

 

The rule applies to both the end product manufacturers and contract manufacturers. “When an establishment experiences a problem, it can have a significant impact on the product lines for one or multiple firms for which it is contracted to provide manufacturing or sterilization services,” the Federal Register reported.  Accordingly, the rule allows the FDA to efficiently and effectively identify which products are manufactured or sterilized at the affected site, and quickly facilitate a recall of impacted devices.

 

Also of note, the rule eliminates an existing exemption that foreign companies that re-export devices from a foreign trade zone didn’t have to comply with electronic registration requirements. By closing the exemption, the rule would facilitate the FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. “The rule will update certain provisions in the regulations to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives,” according to the notice.

 

The final rule is expected to go into effect on October 1, 2012.  A copy of the Federal Register posting may be obtained here.

 

Published In: Administrative Agency Updates, General Business Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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