FDA Updates Disclosure Rules On Medical Device Changes

By Jeff Overley (February 7, 2014, 7:57 PM EST) -- The U.S. Food and Drug Administration on Friday updated its policies on how medical device makers disclose manufacturing and design changes to previously approved products, a process intended to keep regulators apprised of alterations that could influence safety or effectiveness.

In its finalized guidance, the FDA focused on annual reports for riskier Class III devices that are subject to so-called premarket approval, or PMA.

"Annual reports are one of the important tools that FDA relies on to gather information about the device in its post-approval setting," the agency said.

The timing of annual reports corresponds to a device's original approval date....

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