FDA Won't Change Medical Device Notification Rules

Law360, Washington (February 26, 2014, 3:50 PM EST) -- In line with industry feedback, the U.S. Food and Drug Administration said Wednesday it will leave largely unchanged its existing guidance for when a so-called 510(k) notification must be submitted after an existing medical device is modified.

With the 2012 passage of the Food and Drug Administration Safety and Innovation Act, the FDA was required to develop and submit to Congress a report on when a premarket notification under Section 510(k) of the Food, Drug and Cosmetic Act — meant for premarket review of modifications to...
To view the full article, register now.