FDA Finalizes Electronic Registration Rule For Devices

Law360, Washington (August 1, 2012, 5:05 PM EDT) -- The U.S. Food and Drug Administration released its final rule Wednesday requiring medical device manufacturers to register their products electronically rather than via paper forms, saying the system will help the agency be more efficient in its surveillance and recall activities.

The rule, which will be published in the Federal Register on Thursday, will help the agency identify device shortages and sources of product issues as well as conduct recalls and post-market surveillance.

"The new electronic system will allow FDA to more effectively gather information concerning...
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