CDRH Industry: Comment Period Extended to April 10, 2017; “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

The U.S. Food and Drug Administration (FDA) has decided to extend the comment period by 90 days, to April 10, 2017, for the following notice of public hearing that appeared in the FEDERAL REGISTER of September 1, 2016:

• “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

We are taking this action to allow interested persons additional time to submit comments.  FDA intends to formally announce the extension with a notice in the Federal Register in the near future.

FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the comments received in response to this notice of public hearing will inform FDA’s policy development in this area. 

For more information:

Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products:http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm489499.htm