March 12, 2014 by MassDevice
By Stewart Eisenhart, Emergo Group
US regulators have published updated draft guidance on recommendations for distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight. The agency is accepting public comments on the guidance through April 2014.
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. Read more