If you quickly scan through the Federal Register looking for notices that affect either the drug or device industry, you may have missed seeing something important on September 25th. The title of the notice for a proposed rule was “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products.” The title of the notice may be focused on tobacco, but if you look closely, you will see that the proposed changes will modify the definition of “intended use” for drugs (§201.128 Meaning of intended uses) and devices (§801.4 Meaning of intended uses). It is worth a read. There is also a great discussion of this by Jeff Shapiro on the Hyman Phelps FDA Law Blog (http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/10/a-long-overdue-revision-to-the-intended-use-regulation-.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29)

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