US FDA Considering New Requirements for Off-Label Use Data

Revising guidelines originally issued in 2009, the FDA has now developed recommended best practices for manufacturers providing information to medical or scientific publications that discuss unapproved uses for devices already registered for sale in the US.  The guidance includes recommendations for three broad types of information:

  • Scientific or medical journals;
  • Scientific or medical reference texts; and
  • Clinical Practice Guidelines.

Device manufacturers intending to distribute information on unapproved uses of their products should take steps such as peer review, separation of scientific information from promotional or marketing materials, disclosure of any financial ties authors or publishers of materials may have to featured devices or manufacturers, and systematic reviews of existing clinical or scientific evidence.  The FDA’s call for comments on these recommendations were welcomed by industry participants given how thorny the issue of discussing uses of medical devices not covered by their 510(k) premarket notification or Premarket Approval (PMA) registrations can be.

REFERENCE:  Emergo Group; Stewart Eisenhart; 6 MAR 2014

Leave a Comment